Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)

A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glenrose Rehabilitation Hospital, Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
subjects who are not currently receiving any PD treatment

Exclusion criteria

female of child-bearing potential
history of neurosurgical procedures for PD
history of severe psychiatric illness

Treatment and study plan

PYM50028

Drug

IMP

Placebo

Drug

Matching placebo comprising identical vehicle to active doses

Primary outcomes

Unified Parkinson's Disease Rating Scale parts II & III combined score

Time frame: 28 Weeks

Sponsors and collaborators

Lead sponsor

Phytopharm

Industry

Registry information

Official study title

Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks

Acronym: CONFIDENT-PD

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Feb 2, 2010
Registry last updated: Mar 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed