Phase 2A Study of GM 608 in Mild to Moderate Parkinson Disease

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

GM608 is an endogenous human embryonic stage neural regulatory and signaling peptide that controls the development, monitoring and correction of the human nervous system. The study drug is an oligopeptide with a sequence identical to one of the active sites of human Motoneuronotrophic Factor and is manufactured by solid phase synthesis. Preclinical research indicates it to be a neuro-protective agent in animal models of PD, other neuro-degenerative diseases and stroke. This trial is designed to test proof of principle, i.e. determine if a 2-week treatment with this agent can restore the non-functioning nigral dopaminergic neurons in PD over a 3 month period, during which the placebo-treated arm is expected to have little or no worsening of the total UPDRS (Unified Parkinson's Disease Rating Scale)score compared to baseline.

Study Objectives are:

1. To compare the safety and tolerability of GM608 with placebo in a population of patients with early PD.

2. To field test the study procedures for feasibility and efficiency

3. To determine if there is any hint that injections of GM608 might slow the rate of clinical worsening of PD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genervon Biopharmaceuticals, LLC
• Collaborator: Columbia University

Criteria

Inclusion Criteria:

• with mild-moderate idiopathic PD diagnosed based on UK (United Kingdom) PD Brain Bank criteria.

• Age > 30

• Motor UPDRS Score ≥ 15

• Hoehn & Yahr stage <3

• Diagnosis of PD <10 years

• Have fully completed informed consent form

• May be on antiparkinsonian medications of an MAO-B (monoamine oxidase -B) inhibitor, an anticholinergic, or amantadine, but not levodopa or dopamine agonist

Exclusion Criteria:

• Patients with atypical parkinsonism: such as suspected progressive supranuclear palsy (PSP), multiple system atrophy (MSA) or Corticobasal degeneration (CBD) and secondary parkinsonism such as normal-pressure hydrocephalus (NPH), drug-induced, or vascular parkinsonism.

• Patients with uncertainty as to having classical Parkinson disease, such as those who might have scans without evidence of dopaminergic deficit (SWEDDs)

• Patients not willing to give an informed consent

• Patients who are on a dopaminergic medication (levodopa or dopamine agonist)

• Presence of a medical or psychiatric comorbidity that can compromise participation in the study