Patients with upper limb hemiplegia after cerebral infarction or cerebral hemorrhage (other than subarachnoid hemorrhage)
Conditions
Interventions
investigational material(s)
Generic name etc : T-817MA
INN of investigational material : Edonerpic
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage and Administrati
Sponsors
FUJIFILM Toyama Chemical Co., Ltd
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 during the study drug administration period
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 [Efficacy] Change from baseline in the total FMA (upper limb motor function) score | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics [Efficacy] Change from baseline in the total Wolf Motor Function Test (WMFT) score Change from baseline in the total Functional Independence Measure (FIM) score [Safety] Adverse events [Pharmacokinetics] Change in plasma concentration of T-817 and Pharmacokinetic parameters for T-817 | — |
Countries
Japan
Outcome results
None listed