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Trial record 1 of 1 for:    NCT03362294
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Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS

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ClinicalTrials.gov Identifier: NCT03362294
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : November 1, 2022
Information provided by (Responsible Party):
Mapi Pharma Ltd.

Brief Summary:

This is a phase IIa study with GA Depot in subjects with Primary Progressive MS. GA Depot will be administered intramuscularly (IM), once every four weeks for 148 weeks.

The purpose of this study is to assess the safety and efficacy of GA Depot to slow the accumulation of disability progression in subjects with Primary Progressive MS.

Condition or disease Intervention/treatment Phase
Primary Progressive Multiple Sclerosis Drug: GA Depot 40mg once monthly Drug: GA Depot 25mg once monthly Phase 2

Detailed Description:
  • 30 Subjects with a diagnosis of primary progressive multiple sclerosis (PPMS) who are not treated for PPMS at study entry (except for symptoms relief).
  • 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 156 weeks, consisting of 4 weeks of screening evaluation (weeks -4 to 0), followed by a 148-week open-label treatment period, and a 4 weeks follow up period: through a total of 41 visits.
  • Vital signs and safety assessment will be performed at each visit during the study.
  • Physical examination will be performed at screening, baseline, 1 week after the second GA Depot treatment, 3 months after first GA Depot treatment and every 3 months thereafter. Last physical examination will be performed at FU visit.
  • MRI will be performed at screenings and every 6 months thereafter until the end of the treatment period .
  • Safety laboratory tests will be performed at screening, baseline, 1 month after first treatment, and every 3 months thereafter.
  • Neurological assessment will be performed at screening, baseline, 3 months, and then every 3 months until end of treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: The first 20 subjects are allocated to the 40mg arm and the last 10 subjects are allocated to the 25mg.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: GA Depot 40mg once monthly
Monthly IM injection
Drug: GA Depot 40mg once monthly
Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)

Experimental: GA Depot 25mg once monthly
Monthly IM injection
Drug: GA Depot 25mg once monthly
Once-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot)

Primary Outcome Measures :
  1. Safety (Adverse Events and Injection Site Reactions) [ Time Frame: 152 weeks ]
    Assessment of Adverse events (AEs) & Injection Sites Reactions (ISRs)

Secondary Outcome Measures :
  1. Efficacy (Confirmed Disease Progression) [ Time Frame: 148 weeks ]
    Time to onset of Confirmed Disease Progression (CDP) assessed by Expanded Disability Status Scale (EDSS). EDSS is a method of quantifying disability in people with MS. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

  2. Efficacy (Whole brain volume change) [ Time Frame: 148 weeks ]
    MRI assessment of percent of whole brain volume change.

  3. Efficacy (Cortical volume change) [ Time Frame: 148 weeks ]
    MRI assessment of percent of cortical volume change.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female subjects diagnosed with PPMS; Diagnosis of PPMS consistent with the McDonald Criteria (revisions of 2010).
  2. Age between 18 and 65 years (inclusive).
  3. Subjects diagnosed with PPMS for at least 1 year and with signs of disease progression in the year prior to screening, in a rate of ≥ 1 point increase / year in the EDSS score for EDSS between 2-5 and a rate of ≥0.5 point increase / year in the EDSS scores > 5.
  4. EDSS ≥2 and ≤ 6.5 (Pyramidal or Cerebellar FS ≥ 2).
  5. Documented history or the presence at screening of > 1 oligoclonal band (OCB) if quantitative testing was done, or OCB+ if not quantitative testing done and/or positive IgG index in the cerebrospinal fluid (CSF).
  6. Women of child bearing potential must have a negative urine pregnancy test at screening and use an adequate contraceptive method throughout the study.
  7. Ability to provide written informed consent.

Exclusion Criteria:

  1. Subjects with RRMS, SPMS, or PRMS.
  2. Subjects with a documented history of clinical relapse events.
  3. 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.
  4. Contraindications or inability to successfully undergo magnetic resonance imaging (MRI) scanning.
  5. Subjects diagnosed with any other than MS systemic autoimmune disease that may impact the CNS with MS like lesions such as Sarcoidosis, Sjögren's syndrome, Systemic Lupus Erythematosus (SLE), Lyme disease, APLA syndrome, etc.. Subjects with stable local/organ autoimmune disease such as psoriasis, Cutaneous Lupus erythematosus, thyroiditis (Hashimoto, grave) etc. may be considered eligible upon the PI's discretion.
  6. Severe anemia (hemoglobin <10 g/dL).
  7. Abnormal renal function (serum creatinine >1.5xULN or creatinine clearance <30 ml/min).
  8. Abnormal liver function (transaminases >2xULN).
  9. Pregnant or breast-feeding women.
  10. Treatment with any kind of steroids during the last month prior to screening visit.
  11. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a known hypersensitivity to any component of the study drug, e.g. glatiramer acetate (GA), polylactic-co-glycolic acid (PLGA), polyvinyl alcohol (PVA).
  12. Known or suspected history of drug or alcohol abuse.
  13. Known as positive for HIV, hepatitis, VDRL, or tuberculosis.
  14. Active malignant disease of any kind. However, a patient, who had a malignant disease in the past, was treated and is currently disease - free for at least 7 years, may be considered eligible, upon the PI and sponsor's discretion.
  15. Previous treatment with B-cell-targeting therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab or ofatumumab) within 6 months prior to screening visit.
  16. Previous treatment with cladribine within 2 years prior to screening visit
  17. Previous treatment with azathioprine, mitoxantrone or methotrexate within 6 months prior to screening visit.
  18. Previous treatment with lymphocyte-trafficking modifiers (e.g. natalizumab, fingolimod) within 6 months prior to screening visit. Subjects should have a total lymphocyte count within normal range.
  19. Previous treatment with beta interferons, intravenous immunoglobulin, plasmapheresis within 2 months prior to screening visit.
  20. Previous treatment with any glatiramer acetate therapy within 3 months prior to screening visit.
  21. Uncontrolled diabetes.
  22. Participation in an investigational study drug within 30 days prior to study entry.

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): NCT03362294

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Mapi Pharma Research site 09 Recruiting
Haifa, Israel
Contact: Svetlana Afanasiev    +972 4 7771926    s_afanasiev@rmc.gov.il   
Mapi Pharma Research site 07 Recruiting
Jerusalem, Israel
Contact: Keren Dambinsky    02-6777716    keidy@hadassah.org.il   
Mapi Pharma Research site 08 Recruiting
Petah tikva, Israel
Contact: Yaniv Rodity    03-6528734    yar@clalait.org.il   
Mapi Pharma Research site 06 Recruiting
Rehovot, Israel
Contact: Shiran Rogof    08-9441364    shiranro1@clalit.org.il   
Mapi Pharma Research site 01 Recruiting
Tel Aviv, Israel
Contact: Irina Komarov    03-6974380    irinako@tlvmc.gov.il   
Moldova, Republic of
Mapi Pharma Research site 20 Recruiting
Chisinau, Moldova, Republic of
Contact: Mihail Gavriliuc, MD    +37322205383    mgavriliuc@gmail.com   
Mapi Pharma Research site 22 Recruiting
Chisinau, Moldova, Republic of
Contact: Olesea Odainic, MD    +37379443354    oodainic@mail.ru   
Sponsors and Collaborators
Mapi Pharma Ltd.
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Principal Investigator: Arnon Karni, MD Coordinating PI
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Responsible Party: Mapi Pharma Ltd.
ClinicalTrials.gov Identifier: NCT03362294    
Other Study ID Numbers: PPMS-GA Depot 002
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Chronic Disease
Disease Attributes