Quantifying Musical Performance After Treatment With Myobloc in Musician's Dystonia

This study has been completed.
Sponsor:
Collaborator:
Solstice Neurosciences
Information provided by (Responsible Party):
Seth Pullman, Columbia University
ClinicalTrials.gov Identifier:
NCT00208091
First received: September 13, 2005
Last updated: April 11, 2014
Last verified: April 2014
Results First Received: August 22, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Focal Dystonia
Intervention: Drug: Botulinum toxin, type B

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The dates of recruitment for this study were from April 2003 to May 2008. Both male and female subjects were included. Each subject must have been diagnosed with a focal, task-specific dystonia which was clinically determined to be the result of a high level of musical skill and intensive performance history to be included in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Botulinum Toxin, Type B 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.

Participant Flow:   Overall Study
    Botulinum Toxin, Type B  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Botulinum Toxin, Type B 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.

Baseline Measures
    Botulinum Toxin, Type B  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  49.375  ± 13.93  
Gender  
[units: participants]
 
Female     2  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Note Errors (Related to Errors in Duration)   [ Time Frame: Baseline and 6 weeks post-injection ]

2.  Primary:   Note Errors (Related to Errors in Loudness)   [ Time Frame: Baseline and 6 weeks post-injection ]

3.  Secondary:   Subjective Assessment Ratings of Change   [ Time Frame: Baseline to 6 weeks after injection ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Seth Pullman
Organization: Clinical Motor Physiology Laboratory
phone: 212-305-3808
e-mail: sp31@columbia.edu


No publications provided


Responsible Party: Seth Pullman, Columbia University
ClinicalTrials.gov Identifier: NCT00208091     History of Changes
Other Study ID Numbers: AAAB2808
Study First Received: September 13, 2005
Results First Received: August 22, 2013
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board