Phase 2A Study of GM 608 in Mild to Moderate Parkinson Disease
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
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.