Effectiveness of Myobloc in Treating Dystonia in Musicians - Full Text View

Sponsor:	Columbia University
Collaborator:	Solstice Neurosciences
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00208091

Purpose

This study uses a computerized method to quantify musical performance with music notation analysis 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 quantify any improvements or changes in performance following treatment.

Condition	Intervention	Phase
Focal Dystonia	Drug: Botulinum toxin, type B	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Computerized Quantitative Open Label Evaluation of the Efficacy of Myobloc in the Treatment of Focal Dystonia in Musicians

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dystonia

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Pitch [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
Note speed [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
Fatigability [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
Timing [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
Tonal deterioration [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]
Loudness/force [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subjective assessment of improvement by patient on scale of 0-100% [ Time Frame: 6 weeks after injection ] [ Designated as safety issue: No ]

Enrollment:	17
Study Start Date:	April 2003
Estimated Study Completion Date:	January 2009
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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Eligibility

Ages Eligible for Study:	25 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Focal, task-specific dystonia clinically determined to be the result of a high level of musical skill and intensive performance history

Exclusion Criteria:

Neurological disorders other than dystonia
Patients who are clinically depressed, demented or otherwise unable to perform appropriately or sit through 1 hour of testing
Patients who have undergone pallidotomy, thalamotomy or deep brain stimulator implantations
Patients who have who recently have taken medications with extrapyramidal or tremorogenic side effects

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208091

Locations

United States, New York
Neurological Institute, 710 W. 168th Street, NI-1112
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Solstice Neurosciences

Investigators

Principal Investigator:

Seth Pullman, MD

Columbia University Medical Center, Department of Neurology

More Information

No publications provided

Responsible Party:	Columbia University ( Dr. Seth Pullman )
Study ID Numbers:	AAAB2808
Study First Received:	September 13, 2005
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00208091 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dystonic Disorders
Anti-Dyskinesia Agents
Nervous System Diseases
Dystonia
Central Nervous System Diseases
Dyskinesias
Pharmacologic Actions

Signs and Symptoms
Botulinum Toxins
Movement Disorders
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2010