Overview

This trial is active, not recruiting.

Condition multiple sclerosis
Treatments ga depot 80 mg, ga depot 40 mg
Phase phase 1/phase 2
Sponsor Mapi Pharma Ltd.
Start date October 2014
End date June 2017
Trial size 24 participants
Trial identifier NCT02212886, MI GA Depot - 001

Summary

- This is a phase IIa study in which GA Depot 80 or 40mg is administered as an IM injection to subjects with RRMS at 4 week intervals for 52 weeks of treatment.

- The purpose of the study is to assess safety, tolerability, and efficacy of a monthly long-acting IM injection of 80 or 40mg GA Depot in subjects with RRMS. The study will include subjects switching from daily or thrice weekly administration of 20 mg or 40mg respectively of glatiramer acetate (GA, i.e., Copaxone) injection

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Monthly IM injection
ga depot 80 mg Microspheres containing GA
Recruitment completed
(Experimental)
Monthly IM injection
ga depot 40 mg Microspheres containing GA
Recruitment completed

Primary Outcomes

Measure
Safety / Adverse events
time frame: During the study (1 year treatment)

Secondary Outcomes

Measure
Efficacy
time frame: During the study (1 year treatment)
Efficacy
time frame: During the study (1 year treatment)
Efficacy
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Male or female subjects with a diagnosis of RRMS. - Diagnosis of multiple sclerosis (MS) consistent with the McDonald Criteria (revisions of 2010). - Treatment with 20 mg or 40 mg of GA (Copaxone) during the previous 12 months with ongoing treatment at the Screening Visit. - Normal renal function. - Normal liver function. - Normal hemoglobin concentration. - Absence of any clinically significant medical, psychiatric or laboratory abnormalities. - Ability to provide written informed consent. Exclusion Criteria: - Any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study. - Severe anemia (hemoglobin < 10 g/dL). - Abnormal renal function (serum creatinine > 1.5xULN). - Pregnant or breast-feeding women. - Women capable of child bearing must have a negative urine pregnancy test at screening visit and use an adequate contraceptive method throughout the study. Women who are surgically sterile (hysterectomy or tubal ligation) or whose last menstruation was 12 months or more prior to the Screening Visit are considered to be of non-child-bearing potential. Acceptable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; estrogen patch; and adequate barrier methods in conjunction with spermicide. Abstinence is considered an acceptable contraceptive regimen. - History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study drug, e.g. GA, polylactic-co-glycolic acid (PLGA), polyvinyl alcohol (PVA). - Known or suspected history of drug or alcohol abuse. - Positive test for HIV, hepatitis, venereal disease research laboratory test (VDRL), or tuberculosis. Participation in an investigational drug study within 30 days prior to start of this study. - Treatment with any kind of steroids during the last 30 days. - Confirmed relapse during the last 30 days.

Additional Information

Official title A Prospective 1-year, Open-label, Two Arms, Multicentre, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis(RRMS)
Principal investigator Ariel Miller, M.D
Description - 24 Subjects with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who are treated with daily or thrice weekly subcutaneous injections of 20 mg or 40 mg respectively of GA (Copaxone) during the previous 12 months - Study product is GA long-acting injection (GA Depot) which is a combination of extended-release microspheres for injection and diluent (water for injection) for parenteral use. GA Depot will be administered intramuscularly (IM). - The study duration for an individual subject will be 60 weeks, consisting of 4 weeks of screening evaluation (weeks -4 to 0), followed by a 52-week open-label treatment period, and a 4 weeks follow up period: through a total of 17 visits - Physical, vital signs and safety assessment - at each visit - MRI at visit 1 (screenings), at week 24, and week 52 (end of treatment visit) - Neurological and safety laboratory tests at screening visit and on visits in weeks 4, 12, 24, 36, and 52 (end of treatment)
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Mapi Pharma Ltd..