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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 is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 17, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Idiopathic Parkinson's Disease
Drug: Istradefylline 40 mg
Drug: Istradefylline 20 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Pharma, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 609
Study Start Date: October 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: Istradefylline 20 mg
Istradefylline 20 mg and placebo
Other Name: KW-6002
Drug: Placebo
Placebo
Other Name: 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.

Drug: Istradefylline 40 mg
Istradefylline 40 mg and placebo
Other Name: KW-6002
Drug: Placebo
Placebo
Other Name: 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.

Drug: Placebo
Placebo
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968031

Contacts
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-khk.com

  Show 91 Study Locations
Sponsors and Collaborators
Kyowa Hakko Kirin Pharma, Inc.
Kyowa Hakko Kirin Company, Limited
Investigators
Study Chair: Kyowa Hakko Kirin Pharma, Inc. Kyowa Hakko Kirin Pharma, Inc.
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01968031     History of Changes
Other Study ID Numbers: 6002-014, 2013-002254-70
Study First Received: October 18, 2013
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Kyowa Hakko Kirin Pharma, Inc.:
Parkinson's disease
Mild or moderate Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Istradefylline
Adenosine A2 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists

ClinicalTrials.gov processed this record on October 20, 2014