Safety Study of VM202 to Treat Amyotrophic Lateral Sclerosis
This trial is active, not recruiting.
|Condition||amyotrophic lateral sclerosis|
|Phase||phase 1/phase 2|
|Sponsor||ViroMed Co., Ltd. dba VM BioPharma|
|Start date||February 2014|
|End date||September 2015|
|Trial size||18 participants|
|Trial identifier||NCT02039401, VMALS-001 / B|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Number of subjects with serious and non serious adverse events
time frame: Throughout the nine month follow up
Hepatocyte Growth Factor (HGF) serum levels
time frame: immediately pre-treatment on Day 0, immediately pre-treatment on Day 7, immediately pre-treatment on Day 14, immediately pre-treatment on Day 21, on Day 30, Day 60 and Day 90
Copies of VM202 in whole blood
time frame: Day 0, 7, 14, 21 (pre and post last injection), and Day 30, 60 and 90
Male or female participants from 21 years up to 75 years old.
Inclusion Criteria: - Age ≥ 21 years, but < or = 75 years - Subjects diagnosed with: - clinically definite ALS, - clinically probable ALS, or - clinically probable-laboratory supported ALS as specified in the revised El Escorial / Airlie House diagnostic criteria - Onset of ALS < 2 years at Screening - Forced Vital Capacity (FVC) ≥ 60% of predicted - Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) ≥ 30 - Not taking riluzole, or on a stable dose for at least thirty days prior to Screening (defined as no noted toxicities) - Able and willing to give informed consent - If female of childbearing potential, negative urine pregnancy test at Screening and using acceptable method of birth control during the study. Exclusion Criteria: - Neurological symptom(s) due to vitamin B12 deficiency - Requires tracheotomy ventilation or noninvasive ventilation > 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 (HBcAb), antibody to Hepatitis B surface antigen (IgG and IgM; HBsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) 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 (< 5 years) of malignant neoplasm except basal cell carcinoma or squamous cell carcinoma of the skin (if excised and no evidence of recurrence); - Subjects requiring > 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.
|Official title||A Phase I/II, Open Label Study to Assess the Safety and Tolerability of VM202 in Subjects With Amyotrophic Lateral Sclerosis|
|Principal investigator||John A Kessler, MD|
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