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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

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ClinicalTrials.gov Identifier: NCT02212886
Recruitment Status : Active, not recruiting
First Posted : August 8, 2014
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mapi Pharma Ltd.

Tracking Information
First Submitted Date  ICMJE August 5, 2014
First Posted Date  ICMJE August 8, 2014
Last Update Posted Date March 19, 2019
Study Start Date  ICMJE October 2014
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02212886 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2019)
  • 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.
  • 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
  • Efficacy/Changes in EDSS [ Time Frame: 1 year ]
    Change from baseline to end of treatment visit of Expanded Disability Status Scale (EDSS) score.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2014)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS
Official Title  ICMJE 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)
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
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 3 years extension period. During the extension period subjects will receive 40 mg of GA Depot IM once every 4 weeks, 36 times for a total of 144 weeks.
  • Physical, vital signs and safety assessment - at each visit during the core study (physical examination will be assessed reduced to quarterly in 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: GA Depot 80 mg
    Recruitment completed
    Other Name: Microspheres containing GA
  • Drug: GA Depot 40 mg
    Recruitment completed
    Other Name: Microspheres containing GA
Study Arms  ICMJE
  • Experimental: GA Depot 80mg
    Monthly IM injection
    Intervention: Drug: GA Depot 80 mg
  • Experimental: GA Depot 40mg
    Monthly IM injection
    Intervention: Drug: GA Depot 40 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 6, 2014)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02212886
Other Study ID Numbers  ICMJE MI GA Depot - 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mapi Pharma Ltd.
Study Sponsor  ICMJE Mapi Pharma Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shlomo Flechter, M.D
PRS Account Mapi Pharma Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP