CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
Cyproheptadine +3 moredrug
Likely dose
Cyproheptadine 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02418949
NCT02418949N/ACompleted
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Altering Activation Patterns in the Distal Upper Extremity After Stroke

Shirley Ryan AbilityLab·interventional·Posted Apr 17, 2015·Updated Mar 31, 2026

In Brief

A clinical study evaluating Cyproheptadine, Placebo for Cyproheptadine, and 2 other interventions for Stroke and 2 related conditions. Completed, enrolled 96 participants across 1 site.

Detailed Summary

This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase of recovery in which the combination of drug therapy (cyproheptadine) and active movement practice (AMP) is used to encourage increased voluntary muscle control and strength.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Muscle Spasticity, Hemiparesis
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 17, 2015
Enrollment StartNov 1, 2015
Primary CompletionAug 1, 2019
Study CompletionMar 23, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.2 years ago

Interventions

Cyproheptadinedrug

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug

Placebo for Cyproheptadinedrug

Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment. Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug

Active Movement Practice (AMP)other

Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.

Passive Cyclical Stretchingother

Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.