Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT02212886
• Date of registration: 05/08/2014
• Prospective Registration: Yes
• Primary sponsor: Mapi Pharma Ltd.
• Public title: Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS
• Scientific title: A Prospective 1-year, Open-label, Two Arms, Multicenter, 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)
• Date of first enrolment: October 2014
• Target sample size: 25
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02212886
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Israel

Contacts

• Name: Shlomo Flechter, M.D

Key inclusion & exclusion criteria

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.

- Concomitant Autoimmune disease.

- Severe anemia (hemoglobin < 10 g/dL).

- Abnormal renal function (serum creatinine > 1.5xULN).

- Abnormal liver function (transaminases >2xULN).

- 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.

- Active malignant disease of any kind. However, a patient, who has had a malignant
disease in the past, was treated and is currently disease - free for at least 5 years,
may be considered to be enrolled in the study. In this case the sponsor medical expert
approval is required.

- Treatment with any kind of steroids during the last 30 days.

- Confirmed relapse during the last 30 days.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: GA Depot 80 mg

Drug: GA Depot 40 mg

Primary Outcome(s)

Safety / Adverse events [Time Frame: During the study (1 year treatment)]

Secondary Outcome(s)

Efficacy/Changes in brain MRI [Time Frame: During the study (1 year treatment)]

Efficacy/Changes in EDSS [Time Frame: 1 year]

Efficacy/Change in Relapse Rate [Time Frame: During the study (1 year treatment)]

Secondary ID(s)

MI GA Depot - 001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors