Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients
NCT ID: NCT00875316
Last Updated: 2009-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2009-04-30
2009-08-31
Brief Summary
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It is expected that the study will prove that Cogane™ is safe and well tolerated and will provide us with a pharmacokinetic profile for both subject groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Cohort A
Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Cohort B
Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Cohort C
Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Cohort D (Optional)
Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Interventions
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Cogane™ (PYM50028)
Orally active neurotrophic factor inducer
Eligibility Criteria
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Inclusion Criteria
* Females of non-childbearing potential
* General Good Health
* 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
Exclusion Criteria
* 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
* Diagnosis of dementia
* Parkinson's disease of a known genetic cause
* History of surgical intervention for Parkinson's disease
40 Years
80 Years
ALL
Yes
Sponsors
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Phytopharm
INDUSTRY
Responsible Party
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Phytopharm plc
Principal Investigators
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Investigator
Role: PRINCIPAL_INVESTIGATOR
Cambridge, UK
Locations
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LCG Bioscience
Bourn, Cambridgeshire, United Kingdom
Countries
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Other Identifiers
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LCG 2237/08
Identifier Type: -
Identifier Source: secondary_id
P58/07CL/ST/08/01
Identifier Type: -
Identifier Source: org_study_id
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