Unilateral upper limb paralysis after onset of cerebral infarction or cerebral hemorrhage (except subarachnoid hemorrhage)
Conditions
Interventions
investigational material(s)
Generic name etc : Synthesis device for [11C]K-2
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : Be
Sponsors
Takuya Takahashi
FUJIFILM Toyama Chemical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients whose consent of participation in T817MAJP201R is confirmed in written form are judged to be eligible for the registration. 2. Patients whose consent of participation in this trial is confirmed in written form*. * It is allowed for the subject whose paralysis is too severe to sign the consent form to make an observer attend in obtaining informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with advanced renal dysfunction in examinations within 7 days prior to enrollment (creatinine level> 1.5 mg / dL) 2. Patients with severe liver dysfunction in examinations within 7 days prior to enrollment (AST or ALT> 150 IU / L) 3. Patients with contraindications to MRI and AMPA-PET examinations (patients with metal in their bodies, patients with tattoos, patients with claustrophobia etc.) 4. Patients who wish to raise their baby by 7 days after the start of the trial and after 2 days of the second AMPA-PET examination (both men and women) 5. Other patients judged to be unsuitable for the study by the investigator ** Use the latest test results before registration. In addition, the test results conducted in the T817MAJP201R test can also be used.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Identification of the brain regions where there are significant correlations between the difference of total FMA score (upper limb function) from the baseline after final administration of T-817MA or placebo and the difference of image values of 1st and 2nd AMPA PET. | — |
Secondary
| Measure | Time frame |
|---|---|
| other 1. Identification of the brain regions where there are significant correlations between the difference of total FMA score (lower limb function) from the baseline after final administration of T-817MA or placebo and the difference of image values of 1st and 2nd AMPA PET. 2. Identification of the brain regions where there are significant correlations between the difference of total Wolf Motor Function Test (WMFT) score from the baseline after final administration of T-817MA or placebo and the difference of image values of 1st and 2nd AMPA PET. 3. Identification of the brain regions where there are significant correlations between the difference of total Action Research Arm Test (ARAT) score from the baseline after final administration of T-817MA or placebo and the difference of image values of 1st and 2nd AMPA PET. 4. Identification of the brain regions where there are significant correlations between the difference of total Motor Activity Log (MAL) score from the baseline after final administration of T-817MA or placebo and the difference of image values of 1st and 2nd AMPA PET. 5. Identification of the brain regions where there are significant correlations between the difference of total Functional Independence Measure (FIM) score from the baseline after final administration of T-817MA or placebo and the difference of image values of 1st and 2nd AMPA PET. 6. Identification of the brain regions where there are significant differences of image values of 1st and 2nd AMPA PET among 3 arms. | — |
Countries
Japan
Outcome results
None listed