Evidence map›Paper›PMID 26405686›Full record

ArticleNeurology(R) neuroimmunology & neuroinflammation2015

Effects of diazoxide in multiple sclerosis: A randomized, double-blind phase 2 clinical trial.

Pablo Villoslada, Alex Rovira, Xavier Montalban, Rafael Arroyo, Friedemann Paul, Virginia Meca-Lallana, Cristina Ramo, Oscar Fernandez, Albert Saiz, Antonio Garcia-Merino and 12 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology(R) neuroimmunology & neuroinflammation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01428726 (A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple Sclerosis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01428726 phase2completednot on this map

A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple Sclerosis

TypeinterventionalSponsorNeurotec PharmaRan2011 to 2014Enrolled99ConditionsRelapsing Remitting Multiple SclerosisArmsNT-KO-003
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 1 institution in 1 country.

Pablo VillosladaInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Alex RoviraInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Xavier MontalbanInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Rafael ArroyoInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Friedemann PaulInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Virginia Meca-LallanaInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Cristina RamoInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Oscar FernandezInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Albert SaizInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Antonio Garcia-MerinoInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Lluís Ramió-TorrentàInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Bonaventura CasanovaInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Celia Oreja-GuevaraInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Delicias MuñozInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Jose Enrique Martinez-RodriguezInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Eckart LenschInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Jose Maria PrietoInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Sven G MeuthInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Xavier NuñezInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Clara CampásInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
Marco PuglieseInstitut d' Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)-Hospital Clinic (P.V., A.S.), Barcelona, Spain; Unitat de RM (Servei de Radiologia) (A.R., X.M.), Departamento de Neurología-Neuroinmunología, Centro de Esclerosis Múltiple de Cataluña (Cemcat), Hospital Vall d'Hebron, Barcelona, Spain; Hospital Clinico San Carlos (R.A., C.O.-G.), Madrid, Spain; NeuroCure Clinical Research Center and Department of Neurology (F.P.), Charité University Medicine Berlin, Berlin, Germany; Hospital de La Princesa (V.M.-L.), Madrid, Spain; Hospital Germans Trias i Pujol (C.R.), Badalona, Spain; Hospital Regional Universitario (IBIMA) (O.F.), Malaga, Spain; Hospital Puerta de Hierro (A.G.-M.), Madrid, Spain; Hospital Universitari Dr Josep Trueta (L.R.-T.), IDIBGI, Girona, Spain; Hospital La Fe (B.C.), Valencia, Spain; Hospital Xeral-Cies (D.M.), Vigo, Spain; Hospital del Mar (J.E.M.-R.), Barcelona, Spain; Deutsche Klinik für Diagnostik (E.L.), Wiesbaden, Germany; Hospital Universitario Santiago de Compostela (J.M.P.), Spain; Department of Neurology (S.G.M.), University of Munster, Germany; TrialFormSupport (X.N.), Barcelona, Spain; Advancell, Advanced In Vitro Cell Technologies, S.A (C.C.), Barcelona, Spain; and Neurotec Pharma S.L (M.P.), Barcelona, Spain.
NeuroAdvan study
Hospital Clínic de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to test the safety of diazoxide and to search for signs of efficacy in patients with relapsing-remitting multiple sclerosis (RRMS).

methodsIn this multicenter, randomized, placebo-controlled, double-blind trial (treatment allocation was concealed), 102 patients with RRMS were randomized to receive a daily oral dose of diazoxide (0.3 and 4 mg/d) or placebo for 24 weeks (NCT01428726). The primary endpoint was the cumulative number of new T1 gadolinium-enhancing lesions per patient, recorded every 4 weeks from week 4 to week 24. Secondary endpoints included brain MRI variables such as the number of new/enlarging T2 lesions and the percentage brain volume change (PBVC); clinical variables such as the percentage of relapse-free patients, relapse rate, and change in the Expanded Disability Status Scale score; and safety and tolerability.

resultsDiazoxide was well-tolerated and it produced no serious adverse events other than 1 case of Hashimoto disease. At the 2 doses tested, diazoxide did not improve the primary endpoint or the MRI and clinical variables related to the presence of new lesions or relapses. Patients treated with diazoxide showed reduced PBVC compared with the placebo group, although such changes could be confounded by the higher disease activity of the treated group and the vascular effects of diazoxide.

conclusionAt the doses tested, oral diazoxide did not decrease the appearance of new lesions evident by MRI. The effects in slowing the progression of brain atrophy require further validation. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with RRMS, diazoxide (0.3 and 4 mg/d) does not significantly change the number of new MRI T1 gadolinium-enhancing lesions.

Identifiers

PMID26405686
PMCPMC4567455
OpenAlexW2261721005

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