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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01850381
• Date of registration: 07/05/2013
• Prospective Registration: Yes
• Primary sponsor: Genervon Biopharmaceuticals, LLC
• Public title: Phase 2A Study of GM 608 in Mild to Moderate Parkinson Disease GAP-PD
• Scientific title: GM 608 in A Phase IIA Pilot Double-blinded, Randomized, Placebo Controlled Trial in Mild to Moderate Parkinson Disease
• Date of first enrolment: June 2013
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01850381
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Stanley Fahn, MD
• Affiliation: Columbia University Medical Center/NY Presbyterian Hospital

Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: GM608

Drug: Placebo Comparator

Primary Outcome(s)

The change from the mean total UPDRS score of the combined screening and baseline visits to the total UPDRS score at the Week-12 visit, comparing treated with placebo.Compare safety and tolerability with placebo. [Time Frame: Baseline, week 2, week 6, week 12]

Secondary Outcome(s)

Change in Schwab & England ADL (activity of daily living) score from baseline to Week 2 (at visit 6 after dosing), 6, or 12. [Time Frame: Baseline, week 2, week 6, week 12]

Change in total UPDRS between the mean screening-baseline visits and end of Week 2 (at visit 6 after dosing), and week 6, comparing the two arms of the study encompassing the entire cohort of 6 subjects. [Time Frame: Baseline, week 2, week 6]

Change in Hoehn & Yahr score (H&Y), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MOCA) scores from baseline to Week 2 (at visit 6 after dosing), 6, or 12. [Time Frame: Baseline, week 2, week 6, week 12]

Time to the development of sufficient disability to require a change in symptomatic therapy. [Time Frame: 12 weeks]

Change in UPDRS sub-scores (Mental, Activities of Daily Living, Motor) between the mean screening-baseline visits and ends of Week 2 (at visit 6 after dosing), 6, and 12, comparing the two arms of the study encompassing the entire cohort of 6 subjects. [Time Frame: Baseline, week 2, week 6, week 12]

Proportion of subjects requiring additional symptomatic treatment due to disability. [Time Frame: 12 weeks]

Secondary ID(s)

GBD 002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Columbia University