Status:
COMPLETED
Phase 2A Study of GM 608 in Mild to Moderate Parkinson Disease
Lead Sponsor:
Genervon Biopharmaceuticals, LLC
Collaborating Sponsors:
Columbia University
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 oligopep...
Detailed Description
Background The investigational drug GM608 is a synthetic oligopeptide containing 6 amino acids with a sequence identical to one of the active sites of human Motoneuronotrophic factor (MNTF), also refe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01850381
Start Date
June 1 2013
End Date
July 1 2014
Last Update
August 8 2019
Active Locations (1)
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1
Columbia University Medical Center/NY Presbyterian Hospital
New York, New York, United States, 10032