An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 7/14/2016 |
| Start Date: | October 2004 |
| End Date: | May 2007 |
A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.
This is a 1-year, open-label, long-term safety extension for patients who have completed
prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.
prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.
Patients with Parkinson's disease with motor complications on levodopa therapy who completed
the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter
into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg
per day.
the prior double-blind studies 6002-EU-007, 6002-US-013 or 6002-US-018 are eligible to enter
into this 1-year, long-term open safety study with a starting istradefylline dose of 40mg
per day.
Inclusion Criteria:
- Completion of study 6002-EU-007, 6002-US-013 or 6002-US-018
- Non-pregnant and either not of childbearing potential or using specified
contraception
Exclusion Criteria:
- History of psychotic illness
- Variant/atypical Parkinson's disease
- Cancer within 5 years of enrollment
- ALT/AST levels > 1.5 times ULN
- Seizure disorder
- Neuroleptic malignant syndrome
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