Phase 2
Completed N=21
Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
Source: ClinicalTrials.gov NCT02107261 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Physician Global Perception of Change - Blinded Rater 1 — 1; 1; 1; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Global Perception of Change - Blinded Rater 1 |
1; 1; 1; 4; 3; 3 | — |
| PRIMARY Physician Global Perception of Change - Blinded Rater 2 |
0; 0; 1; 2; 4; 5 | — |
| PRIMARY Rating of Overall Musical Performance - Blinded Rater 1 |
0; 1; 2; 2; 0; 3 | — |
| PRIMARY Rating of Overall Musical Performance - Blinded Rater 2 |
0; 0; 3; 2; 0; 4 | — |
| PRIMARY Quantitative MIDI Analysis Comparison |
— | — |
| PRIMARY Blinded High Speed Video Analysis Comparison |
— | — |
| SECONDARY Change in Perceived Stress Scale (PSS) |
-1.429; -0.5031 | — |
| SECONDARY Change in Medical Research Council (MRC) Scale |
0.07; -0.087; -0.013; -0.1190 | — |
| SECONDARY Change in Motor Strength Comparison |
0.679; -3.037; 1.065; -2.323; 0.5570; -2.905 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with focal task-specific dystonia of one or both hands, selectively triggered by performance on a musical instrument.
- Patients must have been evaluated by Dr. Frucht at the Movement Disorders Division of Mount Sinai Medical Center as part of their clinical care.
- Patients whose performance on an instrument is directly linked to their occupation.
- Patients must be between the ages of 18 and 80.
- Impairment in musical performance must be visible and demonstrable.
Exclusion Criteria
- Patients whose dystonia is not severe enough to interfere with musical performance in the opinion of a skilled examiner.
- Patients with unstable medical conditions or psychiatric conditions.
- Patients with a medical condition that precludes them from receiving BoNT injections.
Data sourced from ClinicalTrials.gov (NCT02107261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.