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

Phase 2

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: PYM50028; Drug: Placebo

• Registration Number: NCT01060878
• Lead Sponsor: Phytopharm

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Study Start: 2010-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-01
• Last Update Posted: 2013-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose I	PYM50028	-
Dose III	PYM50028	-
Placebo	Placebo	-
Dose II	PYM50028	-

Primary Outcome Measures

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

Trial Locations

Locations (110)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States

Coastal Neurological Medical Group; 🇺🇸 La Jolla, California, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Pacific Neuroscience; 🇺🇸 Oxnard, California, United States

Ellison Ambulatory Care Center; 🇺🇸 Sacramento, California, United States

The Parkinson's Institute; 🇺🇸 Sunnyvale, California, United States

Colorado Neurological Institute, Rocky Mountain Movement Disorders Center; 🇺🇸 Englewood, Colorado, United States

Hartford Hospital; 🇺🇸 Manchester, Connecticut, United States

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States

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