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A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (KW-6002)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968031
First Posted: October 23, 2013
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kyowa Hakko Kirin Co., Ltd
Information provided by (Responsible Party):
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )
October 18, 2013
October 23, 2013
December 12, 2016
October 2013
October 2016   (Final data collection date for primary outcome 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. ]
Same as current
Complete list of historical versions of study NCT01968031 on ClinicalTrials.gov Archive Site
  • 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. ]
Same as current
Not Provided
Not Provided
 
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
  • Drug: Istradefylline 40 mg
    Istradefylline 40 mg and placebo
    Other Name: KW-6002
  • Drug: Istradefylline 20 mg
    Istradefylline 20 mg and placebo
    Other Name: KW-6002
  • Drug: Placebo
    Placebo
  • Experimental: Istradefylline 20 mg/day

    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.

    Interventions:
    • Drug: Istradefylline 20 mg
    • Drug: Placebo
  • Experimental: Istradefylline 40 mg/day

    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.

    Interventions:
    • Drug: Istradefylline 40 mg
    • Drug: Placebo
  • Placebo Comparator: Placebo

    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.

    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
October 2016
October 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Germany,   Israel,   Italy,   Poland,   Serbia,   United States
 
 
NCT01968031
6002-014
2013-002254-70 ( EudraCT Number )
No
Not Provided
Not Provided
Kyowa Kirin Pharmaceutical Development, Inc. ( Kyowa Hakko Kirin Pharma, Inc. )
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Co., Ltd
Study Chair: Kyowa Hakko Kirin Pharma, Inc. Kyowa Hakko Kirin Pharma, Inc.
Kyowa Kirin Pharmaceutical Development, Inc.
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP