Safety Study of VM202 to Treat Amyotrophic Lateral Sclerosis

Safety Study of VM202 to Treat Amyotrophic Lateral Sclerosis

Quick Info:

Status:
Ongoing, But Not Recruiting
Estimated Enrollment:
18
Phase:
I/II
Treatment Type:
Intramuscular injection, VM202
Trial Type:
Open Label
Sponsor:
ViroMed Co., Ltd. (VM BioPharma)
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
≥ 60%
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
< 2 years
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
N/A
DPS Allowed

Diaphragm Pacer (DPS)

an PALS use a DPS in the trial?
N/A

Update Notes:

11/2/2016No significant updates
2/19/2016No significant updates.
5/21/2015No significant updates.
2/25/2015No significant updates.
1/26/2015Recruitment status updated
8/25/2014No significant updates.
3/5/2014No significant updates.
2/28/2014Recruitment Status Updated.
2/14/2014No significant updates
2/6/2014No significant updates.
2/3/2014No significant updates.
1/27/2014Contact email updated.
1/21/2014New trial added.

Locations:

Northwestern University, Chicago, 60611

Other Information:

Purpose: The purpose of this study is to determine the safety and tolerability of injections of VM202, plasmid DNA encoding two isoforms of hepatocyte growth factor (HGF), into different muscles of people with amyotrophic lateral sclerosis.
Eligibility: People with probable or definite ALS between 21 years to 75 years. Both genders. Not accepting healthy volunteers.
Details: A total dose of 64 mg of VM202 will be administered over the course of four visits: Day 0, Day 7, Day 14, and Day 21. The final dose of VM202 for each target muscle group will be divided and administered 2 weeks apart. A follow-up at 30, 60 and 90 days will then be performed. The primary purpose of this study is to determine whether the drug is safe for people with ALS. Other outcome measures include changes in Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS FRS), forced vital capacity (FVC) and muscle measures including muscle strength.
Collaborator(s):
ALS Forum:
First Published on Clinicaltrials.gov: 1/15/2014
ClinicalTrials.gov ID: NCT02039401
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov