Mechanisms of Neuromuscular Fatigue Post Stroke
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|ClinicalTrials.gov Identifier: NCT01688570|
Recruitment Status : Completed
First Posted : September 20, 2012
Last Update Posted : November 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: duloxetine Drug: Cyproheptadine Drug: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Mechanisms of Neuromuscular Fatigue Post Stroke|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Active Comparator: Duloxetine
Neuromuscular fatigue testing with duloxetine dose
Single dose, orally (pill), 30 mg, taken 6 hours prior to start of the testing session. Subjects will only take a single dose of duloxetine once.
Other Name: Cymbalta
Active Comparator: Cyproheptadine
Neuromuscular fatigue testing with cyproheptadine dose
Single dose, orally, 8 mg, 6 hours prior to the start of the respective testing session. Subjects will take a single dose of cyproheptadine once.
Placebo Comparator: Placebo
Neuromuscular fatigue testing with placebo dose
Single dose, orally, 6 hours prior to the start of the respective testing session. Subjects take a single dose once.
- Force generation [ Time Frame: At time of each of 4 testing sessions (all sessions within a 2 year period). ]Sub-maximal and maximal force measurements will be made during brief contractions during each of the four testing sessions. All sessions will occur at least one week apart and within a total time span of 2 years.
- Surface electromyography (EMG)of lower leg muscles. [ Time Frame: EMG measurements will be made during each of the four sessions. ]Sessions will occur at least a week apart and within a 2 year time span.
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): NCT01688570
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Philip A. Nelson, MD||Medical College of Wisconsin|