A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00455507
First received: April 2, 2007
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa.


Condition Intervention Phase
Parkinson's Disease
Drug: Istradefylline
Drug: Placebo
Phase 2

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: Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study)

Resource links provided by NLM:


Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor. [ Time Frame: Last Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state. [ Time Frame: Every Visit ] [ Designated as safety issue: No ]
  • To evaluate mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia). [ Time Frame: Every Visit ] [ Designated as safety issue: No ]
  • To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). [ Time Frame: Every Visit ] [ Designated as safety issue: No ]
  • To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). [ Time Frame: Visit 4 and Last Visit ] [ Designated as safety issue: No ]
  • To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]

Enrollment: 363
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
Drug: Istradefylline
Two 10 mg KW-6002 tablets orally once daily for 12 weeks
Other Name: KW-6002
Experimental: 2
40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)
Drug: Istradefylline
Two 20 mg tablets orally once a day for 12 weeks
Other Name: KW-6002
Placebo Comparator: 3
Two placebo tablets once daily for 12 weeks
Drug: Placebo
Two placebo tablets orally once daily for 12 weeks

Detailed Description:

To establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD.
  2. PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale.
  3. On levodopa/dopa-decarboxylase inhibitor for at least one year.
  4. Taking at least three doses and >=300mg of levodopa per day for at least four weeks before randomization.
  5. Predictable end of dose wearing off.
  6. Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary.
  7. Have an average of two hours of OFF time on 24-hour diaries.
  8. On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization.
  9. Be at least 20 years of age.
  10. Be willing and able to give written informed consent.

Exclusion Criteria:

  1. Taking any excluded medications.
  2. Neurosurgical treatment or Transcranial Magnetic Stimulation for PD.
  3. Diagnosis of cancer within 5 years.
  4. Diagnosis of clinically significant illness of any organ system.
  5. Diagnosis of dementia or mini-mental status examination score of 25 or less.
  6. History of drug or alcohol abuse or dependence within the past two years.
  7. History of psychosis.
  8. Significant drug allergies.
  9. Taking anticonvulsants for seizures.
  10. History of neurological malignant syndrome.
  11. Pregnant or lactating females.
  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: NCT00455507

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: Study Director Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00455507     History of Changes
Other Study ID Numbers: 6002-0608
Study First Received: April 2, 2007
Last Updated: August 28, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
Parkinson's disease
levodopa
end of dose wearing off
OFF time

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 21, 2014