Cyproheptadine and Chlorpromazine Effects on Spasticity
|ClinicalTrials.gov Identifier: NCT01509885|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : November 20, 2012
|Condition or disease|
|Spinal Cord Injuries Muscle Spasticity|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Phase 3 Study of Cyproheptadine and Chlorpromazine Effects on Spasticity After Spinal Cord Injury|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Complete Spinal Cord Injured Subjects
Patients with no motor scores in their legs and suffering a complete spinal cord injury.
Incomplete Spinal Cord Injured Subjects
Patient with some motor preservation below the injury and suffering an incomplete spinal cord injury.
- Cutaneomuscular Reflex Responses [ Time Frame: Change after drug intake at baseline, 30minutes, 60minutes, 90minutes and 120minutes ]Tibialis anterior reflex responses evoked by stimulation of the medial arch of the foot will be measured before and after drug administration.
- Paired motor unit recordings [ Time Frame: Change at baseline and 30, 60, 90 and 120min after drug intake ]We obtain paired motor unit recordings to determine changes in neuronal excitability after drug intake in incomplete spinal-cord injured subjects only.
- Blood pressure and Heart rate [ Time Frame: Change at baseline and 30, 60, 90, 120 minutes after drug intake ]We measure blood pressure and heart rate to determine the safety of the drug during the experiment and whether we can continue safely.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509885
|University of Alberta|
|Edmonton, Alberta, Canada, T6G2R3|
|Principal Investigator:||Monica A Gorassini, PhD||University of Alberta|