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

Phytopharm

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: PYM50028

Study type: Interventional

Funder types: Industry

Identifiers

NCT01060878

P58/07CL/ST/09/02

Details and patient eligibility

About

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.

Enrollment: 425 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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425 participants in 4 patient groups, including a placebo group

Dose I

Experimental group

Treatment:

Drug: PYM50028

Dose II

Experimental group

Treatment:

Drug: PYM50028

Dose III

Experimental group

Treatment:

Drug: PYM50028

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo