Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
Status:
Completed
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborators:
Merz North America, Inc. Merz Pharmaceuticals, LLC
Treatments:
Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA