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

Parkinson's Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455507
• Other study ID #: 6002-0608
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2007
• Last updated: August 28, 2012
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2012
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Istradefylline
Two 10 mg KW-6002 tablets orally once daily for 12 weeks
• Istradefylline
Two 20 mg tablets orally once a day for 12 weeks
• Placebo
Two placebo tablets orally once daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Last Visit	No
Secondary	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.		Every Visit	No
Secondary	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).		Every Visit	No
Secondary	To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).		Every Visit	No
Secondary	To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).		Visit 4 and Last Visit	No
Secondary	To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline		Every Visit	Yes