Status:
COMPLETED
Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
Lead Sponsor:
Phytopharm
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
Phytopharm plc is developing Cogane™ which is a new medicine for the treatment of Parkinson's disease (PD). The purpose of the study is to find out if Cogane is safe and well tolerated in both healthy...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (Healthy Volunteers):
- Male \& Female healthy volunteers aged between 40 and 80 years at the time of informed consent
- Females of non-childbearing potential
- General Good Health
- Key Exclusion Criteria (Healthy Volunteers):
- No clinically significant and relevant medical history
- Smoked within the 3 months prior to screening
- Use of prescription or non-prescription systemic or topical medication (including herbal remedies) within 14 days of the first dose administration
- Key Inclusion Criteria (Parkinson's disease patients):
- Male \& Female Parkinson's disease patients aged between 40 and 80 years at the time of informed consent
- Must have a diagnosis of idiopathic Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria
- Subjects who are taking Parkinson's disease treatments should be on a stable regimen for at least 4 weeks prior to screening
- Key Exclusion Criteria (Parkinson's disease patients):
- Diagnosis of dementia
- Parkinson's disease of a known genetic cause
- History of surgical intervention for Parkinson's disease
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00875316
Start Date
April 1 2009
End Date
August 1 2009
Last Update
August 21 2009
Active Locations (1)
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1
LCG Bioscience
Bourn, Cambridgeshire, United Kingdom, CB23 2TN