A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study of T-817MA in Post-stroke Patients Undergoing Rehabilitation for Upper Limb Hemiplegia
- Conditions
- Patients with upper limb hemiplegia after stroke (other than subarachnoid hemorrhage)
- Registration Number
- JPRN-jRCT2031190110
- Lead Sponsor
- Sakurai Tsutomu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 65
1.Japanese people resident in Japan
2. Patients diagnosed with initial stroke from MRI or CT
3. Taking the onset date of the stroke to be Day 1 of onset, patients who are able to start administration of the study drug within the period of Days 22 to 56 of onset
4. Patients with serve to moderate upper limb motor functional impairment
5. Patients who can undergo hospitalization and rehabilitation for 3 months
1. Patients who showed marked improvement with rehabilitation alone or patients with poor prognosis who show no effect from rehabilitation . in the screening period
2. Patients who cannot perform joint movement due to synkinesis of upper limb or finger mass flexion
3. Patients with concurrent psychiatric disease such as dementia, depression or schizophrenia
4. Patients with diseases or symptoms that make it difficult to perform rehabilitation of the upper limb or evaluate efficacy
5.Patients with concurrent conditions for which movement of the upper limbs is contraindicated (patients with severe heart disease, uncontrolled hypertension, recent pulmonary embolism or severe orthopedic disease)
6. Patients with historical or concurrent epilepsy
7.Patients who developed convulsion after the onset of stroke
8. Others
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>Change from baseline in the total FMA (upper limb motor function) score
- Secondary Outcome Measures
Name Time Method Efficacy<br>Change from baseline in the total Wolf Motor Function Test (WMFT) score<br>Change from baseline in the total Functional Independence Measure (FIM) score