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

NCT ID: NCT00455507

Last Updated: 2012-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease

Keywords

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Parkinson's disease levodopa end of dose wearing off OFF time

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)

Group Type EXPERIMENTAL

Istradefylline

Intervention Type DRUG

Two 10 mg KW-6002 tablets orally once daily for 12 weeks

2

40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)

Group Type EXPERIMENTAL

Istradefylline

Intervention Type DRUG

Two 20 mg tablets orally once a day for 12 weeks

3

Two placebo tablets once daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Two placebo tablets orally once daily for 12 weeks

Interventions

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Istradefylline

Two 10 mg KW-6002 tablets orally once daily for 12 weeks

Intervention Type DRUG

Istradefylline

Two 20 mg tablets orally once a day for 12 weeks

Intervention Type DRUG

Placebo

Two placebo tablets orally once daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

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KW-6002 KW-6002

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Kyowa Kirin Co., Ltd.

Locations

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Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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6002-0608

Identifier Type: -

Identifier Source: org_study_id