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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00455507
• Date of registration: 02/04/2007
• Prospective Registration: No
• Primary sponsor: Kyowa Hakko Kirin Company, Limited
• Public title: A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking Levodopa
• Scientific title: Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study)
• Date of first enrolment: March 2007
• Target sample size: 363
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00455507
• 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
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Study Director
• Affiliation: Kyowa Hakko Kirin Company, Limited

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: Istradefylline

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS). [Time Frame: Every Visit]

To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I). [Time Frame: Visit 4 and Last Visit]

To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline [Time Frame: Every Visit]

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]

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]

Secondary ID(s)

6002-0608

Source(s) of Monetary Support

Please refer to primary and secondary sponsors