Myobloc Atrophy Study (MAS)
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|ClinicalTrials.gov Identifier: NCT02052024|
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : December 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Spasticity Secondary to Either a Disorder or Trauma Spinal Cord Injury (SCI) Brain Injury Tumor Stroke||Drug: Botox Drug: MYOBLOC||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myobloc Atrophy Study|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Active Comparator: Botox
Treatment group will receive 100 units of BOTOX and will receive 1-3 injections per muscle at each visit.
Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.
Other Name: Botulinum Toxin Type A
Active Comparator: MYOBLOC
Treatment group will receive 5,000 units of MYOBLOC and will receive 1-3 injections per muscle at each visit.
Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.
Other Name: Botulinum Toxin Type B
- Volume and Cross-Sectional Area of Muscle [ Time Frame: 36 Weeks ]The present pilot study is designed to assess the extent to which BTX-A (BOTOX) and BTX-B (MYOBLOC) cause muscle atrophy in spastic patients. The primary objective is to assess whether there is statistically significant difference in muscle atrophy between the two groups over a one-year period. Patient will complete a MRI of the tested muscle at baseline and at the end of the study. The MRI will be completed and read by the same radiologist throughout the study to account for inter rater variability. Note: The radiologist will be blinded to study treatment.
- Modified Ashworth Scale [ Time Frame: 36 Weeks ]The secondary endpoint is improvement in spasticity using the Modified Ashworth Scale. We will review all measures with our statistician. Modified Ashworth scoring will be completed at every visit to evaluate the extent of spasticity before, during and after treatment of which will be conducted by the same rater throughout course of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052024
|United States, District of Columbia|
|Medstar Georgetown University Hospital|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Fernando Pagan, MD||MedStar Georgetown University Hospital|