ODYSSEI Study

Not Applicable

Completed

• Conditions: Parkinson's disease

• Registration Number: JPRN-jRCTs071180014
• Lead Sponsor: Tsuboi Yoshio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1)Current use of levodopa-containing drugs more than 300mg/day administered at least three times daily
2)Patients with wearing-off
3)Patients who have never previously experienced dyskinesia
4)>= 30 to < 80 years of age at the time of consent.
5)Diagnosed as Parkinson's disease based on UK Parkinson's Disease Society Brain Bank criteria
6)Stages <=4 in the ON state for Modified Hoehn and Yahr Scale.
7)Stable antiparkinson drug regimen for at least 4 weeks prior to study entry.
8)Completion of patient diary training and able to satisfactorily complete patient diary.
9)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

Exclusion Criteria

1)Current use of Istradefylline (within 1 year prior to study entry)
2)Current use of amantadine (within 3 months prior to study entry)
3)Current use of an investigational drug (within 4 months prior to study entry.)
4)Patients with dementia or a score of 23 or less on the Mini-Mental State Examination (MMSE)
5)Patients with a previous history of brain surgery for the treatment of parkinson's disease.
6)Current use or plan to administer levodopa/carbidopa intestinal gel
7)Patients with moderate to severe hepatic disorder
8)Current use of a strong inhibitor of CYP3A4 (within 14days prior to study entry)
9)Current use of typical and atypical antipsychotics (within 3 months prior to study entry)
10)Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
11)Patients who are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.

Study & Design

• Study Type: Interventional
• Study Design: Not specified