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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01060878

Acronym

CONFIDENT-PD

Enrollment

425

Registered

2010-02-02

Start date

2010-11-30

Completion date

2012-12-31

Last updated

2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Early-stage

Brief summary

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.

Interventions

DRUGPYM50028

IMP

DRUGPlacebo

Matching placebo comprising identical vehicle to active doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Unified Parkinson's Disease Rating Scale parts II & III combined score	28 Weeks

Countries

Canada, Czechia, France, Germany, Hungary, Poland, Romania, Serbia, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026