Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease Patients

Parkinson's Disease Clinical Trial

Official title:

A Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One Month

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875316
• Other study ID #: P58/07CL/ST/08/01
• Secondary ID: LCG 2237/08
• Status: Completed
• Phase: Phase 1
• First received: April 2, 2009
• Last updated: August 20, 2009
• Start date: April 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Phytopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 volunteers and Parkinson's disease patients and to determine if there is a difference in the way that the body deals with Cogane (pharmacokinetics) between these two groups.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Cogane™ (PYM50028)
Orally active neurotrophic factor inducer

Locations

Country	Name	City	State
United Kingdom	LCG Bioscience	Bourn	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Phytopharm

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the safety and tolerability of Cogane™ oral solution		Throughout 28 day dosing period	Yes
Secondary	To investigate the pharmacokinetic profile of Cogane™ and its metabolites		Throughout 28 day dosing period	No