Trial record 1 of 20 for:    istradefylline
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Kyowa Hakko Kirin Pharma, Inc.
Sponsor:
Collaborator:
Kyowa Hakko Kirin Company, Limited
Information provided by (Responsible Party):
Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01968031
First received: October 18, 2013
Last updated: September 12, 2014
Last verified: September 2014

October 18, 2013
September 12, 2014
October 2013
October 2015   (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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
  • UPDRS Motor Examination Score (Part III); [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ] [ Designated as safety issue: No ]
  • UPDRS Activities of Daily Living (ADL) score (Part II); [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ] [ Designated as safety issue: No ]
  • UPDRS Mentation, Behaviour and Mood (Part I) [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ] [ Designated as safety issue: No ]
  • Total UPDRS (Parts I + II + III); [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ] [ Designated as safety issue: No ]
  • PGI-I scale [ Time Frame: Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit ] [ Designated as safety issue: No ]
  • Sleep time in hours per day based upon 24-hour diaries. [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ] [ Designated as safety issue: No ]
  • Percentage of awake time per day spent in the OFF state [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ] [ Designated as safety issue: No ]
  • Percentage of ON time per day without troublesome dyskinesia. [ Time Frame: Baseline, Week 2, Week 6, Week 10 and Week 12. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI) [ Time Frame: Baseline and Week 12. ] [ Designated as safety issue: No ]
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

A double-blinded, randomized, placebo-controlled study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease who are already on Levodopa/Carbidopa or Levodopa/Benserazide therapy. 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. Patients will continue on their existing Levodopa combination therapy throughout the study period.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Other Name: 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.
 
Recruiting
609
February 2016
October 2015   (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
Both
30 Years and older
No
Contact: Barbara A. Novak, BS MT(ASCP) +1 609-919-1100 ext 7306 bnovak@kyowa-kirin-pharma.com
Contact: Morven Lawson +44 (0) 1896 664000 ext 8170 Morven.Lawson@prostrakan.com
United States,   Canada,   Czech Republic,   Germany,   Israel,   Italy,   Poland,   Serbia
 
NCT01968031
6002-014, 2013-002254-70
No
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Company, Limited
Study Chair: Kyowa Hakko Kirin Pharma, Inc. Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Pharma, Inc.
September 2014

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