A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study of T-817MA in Post-stroke Patients Undergoing Rehabilitation for Upper Limb Hemiplegia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031190110

Enrollment

Registered

2019-10-04

Start date

2019-06-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with upper limb hemiplegia after stroke (other than subarachnoid hemorrhage)

Interventions

T-817MA or placebo will be administered in patients with upper limb hemiplegia after stroke undergoing rehabilitation.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Efficacy Change from baseline in the total FMA (upper limb motor function) score	—

Secondary

Measure	Time frame
Efficacy Change from baseline in the total Wolf Motor Function Test (WMFT) score Change from baseline in the total Functional Independence Measure (FIM) score	—

Contacts

Public ContactClinical Trial Information Officer

FUJIFILM Toyama Chemical Co., Ltd

fftc-clinicaltrial-info1@fujifilm.com+81-3-6228-3129

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026