Overview

This trial is active, not recruiting.

Condition idiopathic parkinson's disease
Treatments istradefylline 40 mg, istradefylline 20 mg, placebo
Phase phase 3
Sponsor Kyowa Hakko Kirin Pharma, Inc.
Collaborator Kyowa Hakko Kirin Company, Limited
Start date October 2013
End date November 2016
Trial size 609 participants
Trial identifier NCT01968031, 2013-002254-70, 6002-014

Summary

This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
istradefylline 20 mg KW-6002
Istradefylline 20 mg and placebo
placebo
Placebo
(Experimental)
Istradefylline 40 mg and placebo to match istradefylline 20 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
istradefylline 40 mg KW-6002
Istradefylline 40 mg and placebo
placebo
Placebo
(Placebo Comparator)
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg: A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
placebo
Placebo

Primary Outcomes

Measure
The primary efficacy variable is change from Baseline in the total hours of awake time per day spent in the OFF state.
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.

Secondary Outcomes

Measure
Total hours of ON time per day without troublesome dyskinesia;
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
UPDRS Motor Examination Score (Part III);
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
UPDRS Activities of Daily Living (ADL) score (Part II);
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
UPDRS Mentation, Behaviour and Mood (Part I)
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Total UPDRS (Parts I + II + III);
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
PGI-I scale
time frame: Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit
Sleep time in hours per day based upon 24-hour diaries.
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of awake time per day spent in the OFF state
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Percentage of ON time per day without troublesome dyskinesia.
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Total hours of ON time and percentage of ON time per day (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
time frame: Baseline, Week 2, Week 6, Week 10 and Week 12.
Montreal Cognitive Assessment (MoCA)
time frame: Baseline and Week 12.
Beck Depression Inventory (BDI)
time frame: Baseline and Week 12.

Eligibility Criteria

Male or female participants at least 30 years old.

Inclusion Criteria: - 30 years of age or older. - UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD - PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale. - On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit - Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization - Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization - Documented end-of-dose wearing-off and levodopa-induced dyskinesia - Have an average of two hours of OFF time per day Exclusion Criteria: - Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion. - Subject who have had neurosurgical operation for PD - Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers - Subjects who smoke > 5 cigarettes/day

Additional Information

Official title A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Kyowa Kirin Pharmaceutical Development, Inc..