Evidence map›Paper›PMID 30009213›Full record

ArticleMovement disorders clinical practice

Injectable DaxibotulinumtoxinA in Cervical Dystonia: A Phase 2 Dose-Escalation Multicenter Study.

Joseph Jankovic, Daniel Truong, Atul T Patel, Allison Brashear, Marian Evatt, Roman G Rubio, Chad K Oh, Daniel Snyder, Gill Shears, Cynthia Comella

Registry-linked trialOpen access · bronzeAbstract read
In one paragraph

Article in Movement disorders clinical practice. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05158166 (DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
4.9field-weighted citation impact, top 5% 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.

NCT05158166 phase1 / phase2completednot on this map

DaxibotulinumtoxinA Injection for Treatment of Adductor Spasmodic Dysphonia

TypeinterventionalSponsorUniversity of California, San FranciscoRan2023 to 2025Enrolled22ConditionsAdductor Spasmodic Dysphonia, Voice Disorders, Spasmodic DysphoniaArmsDaxibotulinumtoxinA
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 55 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Sensorimotor Perceptive Rehabilitation Integrated (SPRInt) program: exercises with augmented movement feedback associated to botulinum neurotoxin in idiopathic cervical dystonia-an observational study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2020
    Trial
  5. Therapeutic botulinum toxin preparations: an update.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. CPP Applications in Immune Modulation and Disease Therapy.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. The Use of Botulinum Toxin for Treatment of Spasticity.Handbook of experimental pharmacology · 2021
    Article
  19. Novel Native and Engineered Botulinum Neurotoxins.Handbook of experimental pharmacology · 2021
    Review
  20. It's tricky: Rating alleviating maneuvers in cervical dystonia.Journal of the neurological sciences · 2020
    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

10 authors at 7 institutions in 2 countries.

Joseph JankovicParkinson's Disease Center and Movement Disorders Clinic Department of Neurology, Baylor College of Medicine Houston TX.
Daniel TruongThe Parkinson's and Movement Disorder Institute Fountain Valley CA.
Atul T PatelKansas City Bone & Joint Clinic Overland Park KS.
Allison BrashearWake Forest Baptist Medical Center Winston Salem NC.
Marian EvattActing Chief, Neurology Department of Veterans Affairs Medical Center, Atlanta, GA and Department of Neurology Emory University Atlanta GA.
Roman G RubioRevance Therapeutics, Inc. Newark CA.
Chad K OhRevance Therapeutics, Inc. Newark CA.
Daniel SnyderRevance Therapeutics, Inc. Newark CA.
Gill ShearsWrite on Target Ltd. Leighton Buzzard UK.
Cynthia ComellaRush University Medical Center Chicago IL.
Covance (United States) · USAtlanta VA Medical Center · USAtrium Health Wake Forest Baptist · USBaylor College of Medicine · USFoundation for Water Research · GBParkinson's and Movement Disorder Institute · USRush University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInjectable daxibotulinumtoxinA (an investigational botulinum toxin, RT002) may offer a more prolonged duration of response-and therefore less frequent dosing-than onabotulinumtoxinA.

objectivesTo perform a phase 2, open-label, dose-escalation study to assess the efficacy and safety of daxibotulinumtoxinA in cervical dystonia.

methodsSubjects with moderate-to-severe isolated cervical dystonia were enrolled in sequential cohorts to receive a single open-label, intramuscular dose of injectable daxibotulinumtoxinA of up to 200 U (

resultsOverall, 33/37 enrollees completed the trial. DaxibotulinumtoxinA was associated with mean reductions in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)-Total score of 16.8 (38%) at week 4, 21.3 (50%) at week 6, and 12.8 (30%) at week 24. The proportion of subjects who were responders (achieved ≥ 20% reduction in TWSTRS-Total score) was 94% at week 6 and 68% at week 24. The median duration of response (time until > 20% of the improvement in TWSTRS-Total score achieved at week 4 was no longer retained or re-treatment was needed) was 25.3 weeks (95% CI, 20.14-26.14 weeks). There were no serious adverse events and there was no apparent dose-related increase in the incidence of adverse events. The most common treatment-related adverse events were dysphagia (14%) and injection site erythema (8%).

conclusionsPreliminary assessments suggest that injectable daxibotulinumtoxinA at doses up to 450 U is well tolerated and may offer prolonged efficacy in the treatment of cervical dystonia. Further studies involving larger numbers of patients are now warranted.

Indexed as

botulinum toxinCDIPcervical dystoniadaxibotulinumtoxinATWSTRS

Identifiers

PMID30009213
PMCPMC6032882
OpenAlexW2793234123

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.