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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mapi Pharma Ltd.
ClinicalTrials.gov Identifier:
NCT02212886
First received: August 5, 2014
Last updated: June 1, 2016
Last verified: June 2016
  Purpose
  • 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 Intervention Phase
Multiple Sclerosis
Drug: GA Depot 80 mg
Drug: GA Depot 40 mg
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Mapi Pharma Ltd.:

Primary Outcome Measures:
  • 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:
  • Efficacy [ 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.

  • Efficacy [ 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

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


Enrollment: 24
Study Start Date: October 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02212886

Locations
Israel
Barzilai Medical Center
Ashkelon, Israel
Carmel Medical Center
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Hadassah Ein-Kerem
Jerusalem, Israel
Kaplan Medical Center
Rehovot, Israel
TASMC
Tel Aviv, Israel
Sheba MC
Tel Hashomer, Israel
Assaf Harofeh MC
Tzrifin, Israel
Sponsors and Collaborators
Mapi Pharma Ltd.
Investigators
Principal Investigator: Ariel Miller, M.D
  More Information

Responsible Party: Mapi Pharma Ltd.
ClinicalTrials.gov Identifier: NCT02212886     History of Changes
Other Study ID Numbers: MI GA Depot - 001
Study First Received: August 5, 2014
Last Updated: June 1, 2016

Keywords provided by Mapi Pharma Ltd.:
Glatiramer acetate
Copaxone
Multiple sclerosis
Relapsing remitting multiple sclerosis
RRMS
GA Depot
Monthly injection

Additional relevant MeSH terms:
Sclerosis
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
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 25, 2017