Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02107261 · ClinicalTrials.gov registry record · Phase 2
Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
A Phase 2 study of Dystonia, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT02107261 is a Phase 2 study of Dystonia that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 21 participants, below the 539-participant average among 28 other Dystonia trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02107261, a Phase 2 study of Dystonia, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®). Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves, inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be critical for the musical professional to continue his or her career. With the use of EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize the individual muscles that are affected in this condition with great accuracy. Prior studies have shown that BoNT injections produce beneficial effects in forearm muscles, and less effect in shoulder or proximal arm muscles. Possible risks in treating patients with BoNT include excessive weakness of the injected muscles. The drug may also affect non-targeted muscles. However these risks will be minimized during the screening period by carefully targeting the affected muscles and by administering low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks after the primary injection date) if the initial injection was insufficient to produce sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of the targeted muscle.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG incobotulinumtoxin A
Study Locations (2)
New York
- NYU Langone Health - New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2014-03 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02107261
The ClinicalTrials.gov registry entry for NCT02107261 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 539-participant average among 28 other Dystonia trials with a reported enrollment target (96% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dystonia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02107261 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT02107261 about?
NCT02107261 is a clinical study titled "Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand". The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®). Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves, inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In musician's dystonia, the ability to...
What is the current status of trial NCT02107261?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2014-03. Estimated completion is 2020-01-27.
What conditions does trial NCT02107261 study?
This clinical trial studies the following conditions: Dystonia.
What interventions are being tested in trial NCT02107261?
The interventions under investigation include: Placebo (DRUG), incobotulinumtoxin A (DRUG).
Who is sponsoring clinical trial NCT02107261?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02107261 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dystonia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
RECRUITING · Phase 2
-
Effects of Exercise on Dystonia Pathophysiology
RECRUITING · NA
-
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
RECRUITING
-
Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
RECRUITING · NA
-
Dystonia Genotype-Phenotype Correlation
RECRUITING
-
Sleep-specific DBS Therapy in Parkinson's Disease
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.