Phase 2
N=18
Safety Study of VM202 to Treat Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02039401 ↗Enrolled (actual)
18
Serious AEs
16.7%
Results posted
Sep 2023
Primary outcome: Primary: Number of Subjects With Serious and Non Serious Adverse Events — 1; 1; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VM202 (Biological)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Helixmith Co., Ltd.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious and Non Serious Adverse Events |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY The Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) |
39.89; 38.11; 39; 40.22; 37.11; 38.67 | — |
| SECONDARY Change in Mean Muscle Strength Medical Research Council (MRC) Scores |
-0.67; -3.78; -2.22; -0.63; -2.89; -1.82 | — |
| SECONDARY Change From Baseline (Day 0) in Forced Vital Capacity (%) |
-1.67; -4.11; -2.89; -5; -8.33; -6.76 | — |
Summary
The purpose of this study is to determine the safety and tolerability of intramuscular injections of VM202 at different injection sites in people with amyotrophic lateral sclerosis.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 21 years, but 16 hours / day
- Comorbidities such as Parkinson's disease, schizophrenia, renal failure, or any other severe complication that, in the Investigator's opinion, will compromise the safety of the patient or confound interpretation of the data collected in this study
- Other neuromuscular disease
- Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease)
- Active infection
- Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis)
- Positive HIV or HTLV at Screening
- Active Hepatitis B or C as determined by Hepatitis B core antibody, antibody to Hepatitis B surface antigen (IgG and IgM), Hepatitis B surface antigen and Hepatitis C antibodies at Screening
- Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy
- Stroke or myocardial infarction within last 3 months
- Patients with a recent history ( 81 mg daily of acetylsalicylic acid; subjects may be enrolled if willing/able to switch to ≤ 81 mg daily of acetylsalicylic acid or to another medication
- Subjects requiring regular COX-2 inhibitor drug(s) or non-specific COX-1/COX-2 inhibiting drugs, or high dose steroids (excepting inhaled steroids); subjects may be enrolled if willing/able to undergo medication wash-out prior to the first dosing and to refrain from taking these drugs for the duration of the study
- Have used an investigational drug within 30 days of Screening
- Pregnant or currently lactating
- Major psychiatric disorder in past 6 months
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the Investigator are not suitable to participate.
Data sourced from ClinicalTrials.gov (NCT02039401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.