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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02212886
Recruitment Status : Active, not recruiting
First Posted : August 8, 2014
Last Update Posted : November 1, 2022
Information provided by (Responsible Party):
Mapi Pharma Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: GA Depot 80 mg Drug: GA Depot 40 mg Phase 1 Phase 2

Detailed Description:
  • 25 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 in the core study 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.
  • For both arms, subjects who completed 13 injections and who consented (by signing an informed consent) are able to enter the optional 8 years extension period. During the extension period subjects will receive 40 mg of GA Depot IM once every 4 weeks.
  • Physical, vital signs and safety assessment - will be performed at each visit during the whole study. Physical examination will be performed quarterly during the extension period.
  • MRI at visit 1 (screenings), at week 24, week 52 (end of core study) and every 6 months during the extension period.
  • Neurological and safety laboratory tests at screening visit, on visits in weeks 4, 12, 24, 36, 52 (end of core study) and every 6 months during the extension period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : October 2014
Actual Primary Completion Date : May 2017
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GA Depot 80mg
Monthly IM injection
Drug: GA Depot 80 mg
Recruitment completed
Other Name: Microspheres containing GA

Experimental: GA Depot 40mg
Monthly IM injection
Drug: GA Depot 40 mg
Recruitment completed
Other Name: Microspheres containing GA

Primary Outcome Measures :
  1. Safety / Adverse events [ Time Frame: During the study (1 year treatment) ]
    Number of patients experiencing adverse events and assessments of localized skin reactions at injection sites.

Secondary Outcome Measures :
  1. Efficacy/Change in Relapse Rate [ Time Frame: During the study (1 year treatment) ]
    Relapse rate detected during the study compared to relapse rate observed in the 12 months prior to study start.

  2. Efficacy/Changes in brain MRI [ Time Frame: During the study (1 year treatment) ]
    Changes from baseline to end of treatment visit in the number of enhancing lesions and new lesions images of brain MRI

  3. Efficacy/Changes in EDSS [ Time Frame: 1 year ]
    Change from baseline to end of treatment visit of Expanded Disability Status Scale (EDSS) score.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212886

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Barzilai Medical Center
Ashkelon, Israel
Rambam Medical Center
Haifa, Israel
Tel Aviv, Israel
Sponsors and Collaborators
Mapi Pharma Ltd.
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Principal Investigator: Shlomo Flechter, M.D
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Responsible Party: Mapi Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02212886    
Other Study ID Numbers: MI GA Depot - 001
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: September 2022
Keywords provided by Mapi Pharma Ltd.:
Glatiramer acetate
Multiple sclerosis
Relapsing remitting multiple sclerosis
GA Depot
Monthly injection
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases