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About
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.
Full description
The study will be conducted in three periods:
Enrollment
Sex
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Volunteers
Inclusion criteria
Male or female between 40 years of age and older
Body mass index of 19.0-40.0 kg/m2;
Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;
Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;
Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:
Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment; 8. Properly complete and return a self-reported home diary for motor function status (Hauser Diary) during the Screening Period, which confirms 3 days (ie, 3 consecutive, 24-hour periods) immediately prior to Baseline, each with at least 2½ hours of OFF time during waking hours.
Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
132 participants in 2 patient groups, including a placebo group
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Central trial contact
ITI Clinical Trials
Data sourced from clinicaltrials.gov
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