APISJ Study
- Conditions
- Parkinson's disease
- Registration Number
- JPRN-jRCTs051180185
- Lead Sponsor
- Takahashi Makio
- Brief Summary
This is the first clinical study to investigate the efficacy of istradefylline, an adenosine A2A receptor antagonist, also known as a non-dopaminergic anti-parkinsonian agent, for the treatment of postural abnormality in patients with PD using UDRS as the primary outcome during the 24-week treatment. In the present study, Istradefylline was found to be effective for postural abnormalities in PD. Istradefylline may be a potential treatment option for postural abnormality in PD patients on levodopa treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
1) patients with wearing-off phenomena in parkinson's disease currently treated with levodopa-containing products
2) abnormal posture due to parkinson's disease within 2 years from onset of abnormal posture
3) at a stage of <= IV according to the modified hoehn and yahr scale (on state)
4) aged 30 years or older at the time of consent
5) patients who have given written consent. if the patient has difficulty in writing due to his or her condition, a representative may sign the written consent, subject to the patient's prior oral consent.
1) a score of <= 20 on the mini-mental state examination (MMSE)
2) patients with abnormal posture which is not derived from parkinson's disease (e.g. compressed fracture of backbone, fracture of the pelvis, drug-induced abnormal posture)
3) patients with impact for evaluation by such treatment as deep brain stimulation transcranial magnetic stimulation or electroconvulsive therapy et cetera.
4) current use or plan to administer levodopa/carbidopa intestinal gel
5) ongoing treatment with botulinus toxin or passed treatment with botulinus toxin within 6 months
6) ongoing treatment with istradefylline or passed treatment with istradefylline within 1 year
7) moderate to severe hepatic disorder or current treatment with a strong inhibitor of cyp3a4
8) lactating, pregnant, or possibly pregnant women
9) other conditions judged by the investigator or subinvestigator to be unsuitable for participation in the research
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the total UDRS score before and after administration of Istradefylline
- Secondary Outcome Measures
Name Time Method Change in the total score of MDS-UPDRS Part I and Part III, each MDS-UPDRS Part I and Part III score, each UDRS score, mH&Y score (On/Off), FOG-Q score, CGI score and PDQ-8 score