A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Placebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250393
• Other study ID #: 6002-0407
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2005
• Last updated: August 28, 2012
• Start date: November 2005
• Est. completion date: October 2006

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

To establish the efficacy of 40 mg/day doses of istradefylline for the change in Unified Parkinson's Disease Rating Scale (UPDRS) part-III (Motor examination) score in patients with Parkinson's disease (PD).

Description:

To establish the efficacy of 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD). Patients who meet entry criteria will be randomly assigned to receive study drug in 1 of 2 arms: Condition A (doses of 40mg/d istradefylline) in Period 1 followed by Condition B (matching placebo) in Period 2 (putting 4 weeks interval phase between two periods ) or Condition B in Period 1 followed by Condition A in Period 2(putting 4 weeks interval phase between two periods ). Patients will be participated 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: 64
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 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 1-3 for Modified Hoehn and Yahr Scale.

3. Be at least 30 years of age.

Exclusion Criteria:

1. Neurosurgical treatment for PD.

2. History of psychosis.

3. Diagnosis of cancer within 5 years.

4. Diagnosis of clinically significant illness of any organ system.

5. Mini-mental status examination score of 25 or less.

6. Taking any excluded medications.

7. History of drug or alcohol abuse or dependence within the past two years.

8. History of seizures or neurological malignant syndrome.

9. Clinical depression.

10. Pregnant or lactating females.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Istradefylline (KW-6002)

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 40mg/d doses of istradefylline for the change in UPDRS part-III (Motor examination) score in patients with Parkinson's disease (PD).
Secondary	To evaluate the efficacy of 40mg/d dose of istradefylline for the change in UPDRS part-I (Mentation, behavior and mood), part-II (Activities of daily living) score and UPDRS total (parts I-III) score.
Secondary	To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).
Secondary	To evaluate change in the Clinical Global Impression - Severity of Illness scale (CGI-S).
Secondary	To evaluate the safety of 40mg/d doses of istradefylline.