CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Botulinum toxin, type Bdrug
Likely dose
Botulinum toxin type B 500 Units/0.1 ml, injected into affected muscle(s) with electromyographic guidance; dosage adjusted according to muscle(s) and symptom severityAI-extracted
Key inclusion· 1
  • ✓Focal, task-specific dystonia resulting from high level of musical skill and intensive performance history
Key exclusion· 4
  • ✕Neurological disorders other than dystonia
  • ✕Clinical depression, dementia, or inability to complete 1 hour of testing
  • ✕Prior pallidotomy, thalamotomy, or deep brain stimulator implantation
  • ✕Recent use of medications with extrapyramidal or tremorogenic side effects

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00208091
NCT00208091Phase 4Completed
CompareCT.gov

An Open Label Evaluation of MIDI to Quantify Performance Change in Subjects With Musician's Dystonia After Treatment With Botulinum Toxin Type B (Myobloc ®).

Columbia University·interventional·Posted Sep 21, 2005·Updated May 9, 2014

In Brief

A Phase 4 clinical trial evaluating Botulinum toxin, type B for Focal Dystonia. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This study uses a computerized method of musical instrument digital interface (MIDI) quantification of performance before and after treatment with botulinum toxin type B (Myobloc ®, Solstice Neurosciences). Myobloc is a purified and diluted form of botulinum toxin used medically to relax unwanted muscle spasms and movements. The aim of the study is to determine the feasibility of quantifying change in performance following treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFocal Dystonia
CountriesUnited States
CollaboratorsSolstice Neurosciences

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartApr 1, 2003
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.8 years ago

Interventions

Botulinum toxin, type Bdrug

Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.