Evidence map›Paper›PMID 27159993›Full record

Trial reportJournal of neurology2016

A double-blind, randomized, cross-over, placebo-controlled, pilot trial with Sativex in Huntington's disease.

Jose Luis López-Sendón Moreno, Juan García Caldentey, Patricia Trigo Cubillo, Carolina Ruiz Romero, Guillermo García Ribas, M A Alonso Alonso Arias, María Jesús García de Yébenes, Rosa María Tolón, Ismael Galve-Roperh, Onintza Sagredo and 7 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01502046 (A Double Blind, Randomized, Cross Over, Placebo Controlled Phase 2 Clinical Trial to Asses Neuroprotection by Cannabinoids in Huntington's Disease), which is not on this map. Cited by 66 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 7 pooled it
7.5field-weighted citation impact, top 2% 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.

NCT01502046 phase2completednot on this map

A Double Blind, Randomized, Cross Over, Placebo Controlled Phase 2 Clinical Trial to Asses Neuroprotection by Cannabinoids in Huntington's Disease

TypeinterventionalSponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalRan2011 to 2012Enrolled25ConditionsHuntington's DiseaseArmsdelta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), Placebo
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 7 syntheses or guidelines pooled it, 156 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Cannabinoids for the treatment of dementia.The Cochrane database of systematic reviews · 2021
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Article
  9. Review
  10. The Use of Cannabis-Based Medicine in Selected Neurological Disorders.Current topics in behavioral neurosciences · 2026
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Therapeutic use of medical Cannabis in neurological diseases: a clinical update.Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Review
  17. Review
  18. Review
  19. Article
  20. Review

6 more citing papers are in PubMed but not listed here.

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

17 authors at 6 institutions in 1 country.

Jose Luis López-Sendón MorenoNeurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain. joselopezsendon@hotmail.com.
Juan García CaldenteyNeurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain.
Patricia Trigo CubilloNeurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain.
Carolina Ruiz RomeroNeurobiology Department, Hospital Ramón y Cajal, Madrid, Spain.
Guillermo García RibasNeurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain.
M A Alonso Alonso AriasNeurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain.
María Jesús García de YébenesInstituto de Salud Músculoesquelética, Madrid, Spain.
Rosa María TolónFundación Hospital de Alcorcón, Madrid, Spain.
Ismael Galve-RoperhDepartment of Biochemistry and Molecular Biology I, Faculty of Biology, Complutense University, Madrid, Spain.
Onintza SagredoCentro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain.
Sara ValdeolivasCentro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain.
Eva ReselDepartment of Biochemistry and Molecular Biology I, Faculty of Biology, Complutense University, Madrid, Spain.
Silvia Ortega-GutierrezDepartment of Organic Chemistry I, Faculty of Chemistry, Complutense University, Madrid, Spain.
María Laura García-BermejoInstituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.
Javier Fernández RuizCentro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Madrid, Spain.
Manuel GuzmánDepartment of Biochemistry and Molecular Biology I, Faculty of Biology, Complutense University, Madrid, Spain.
Justo García de Yébenes ProusNeurology Department, Hospital Ramón y Cajal, Carretera de Colmenar Km 9.100, 28034, Madrid, Spain.
Hospital Universitario Ramón y Cajal · ESBiomedical Research Networking Center on Neurodegenerative Diseases · ESInstituto Ramón y Cajal de Investigación Sanitaria · ESHospital Universitario Fundación Alcorcón · ESInstituto de Salud Musculoesquelética · ESUniversidad Complutense de Madrid · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Huntington's disease (HD) is a neurodegenerative disease for which there is no curative treatment available. Given that the endocannabinoid system is involved in the pathogenesis of HD mouse models, stimulation of specific targets within this signaling system has been investigated as a promising therapeutic agent in HD. We conducted a double-blind, randomized, placebo-controlled, cross-over pilot clinical trial with Sativex(®), a botanical extract with an equimolecular combination of delta-9-tetrahydrocannabinol and cannabidiol. Both Sativex(®) and placebo were dispensed as an oral spray, to be administered up to 12 sprays/day for 12 weeks. The primary objective was safety, assessed by the absence of more severe adverse events (SAE) and no greater deterioration of motor, cognitive, behavioral and functional scales during the phase of active treatment. Secondary objectives were clinical improvement of Unified Huntington Disease Rating Scale scores. Twenty-six patients were randomized and 24 completed the trial. After ruling-out period and sequence effects, safety and tolerability were confirmed. No differences on motor (p = 0.286), cognitive (p = 0.824), behavioral (p = 1.0) and functional (p = 0.581) scores were detected during treatment with Sativex(®) as compared to placebo. No significant molecular effects were detected on the biomarker analysis. Sativex(®) is safe and well tolerated in patients with HD, with no SAE or clinical worsening. No significant symptomatic effects were detected at the prescribed dosage and for a 12-week period. Also, no significant molecular changes were observed on the biomarkers. Future study designs should consider higher doses, longer treatment periods and/or alternative cannabinoid combinations.Clincaltrals.gov identifier: NCT01502046.

Indexed as

Plant StructuresAdultAmino AcidsAmyloid beta-PeptidesBiogenic MonoaminesCannabidiolCross-Over StudiesDronabinolDrug CombinationsEndocannabinoidsFemaleFibroblastsFollow-Up StudiesGene Expression RegulationHumansHuntington DiseaseAmino AcidsAmyloid beta-Peptidesamyloid beta-protein (1-42)Biogenic MonoaminesCannabidiolDronabinolDrug CombinationsEndocannabinoidsMicroRNAsMIRN34 microRNA, humannabiximolsPeptide FragmentsPlant Extractstau ProteinsCannabinoidClinical trialHuntington’s diseaseSativex

Identifiers

PMID27159993
OpenAlexW2346108119

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.