Monthly MS injection aims to halt disability progression
NCT ID NCT03362294
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a long-acting form of glatiramer acetate (GA Depot) given as a monthly shot to people with primary progressive multiple sclerosis (PPMS). The goal was to see if it could safely slow down worsening disability. The trial was stopped early, but it involved 30 adults aged 18-65 with PPMS who received either 25 mg or 40 mg of the drug every four weeks for nearly three years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Dec 2017
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mapi Pharma Research site 01
Tel Aviv, Israel
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Mapi Pharma Research site 06
Rehovot, Israel
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Mapi Pharma Research site 07
Jerusalem, Israel
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Mapi Pharma Research site 08
Petah Tikva, Israel
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Mapi Pharma Research site 09
Haifa, Israel
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Mapi Pharma Research site 20
Chisinau, Moldova
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Mapi Pharma Research site 22
Chisinau, Moldova
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Other studies related to the condition(s) this trial covers.
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- Can engineered immune cells tame autoimmune diseases?
- Can a blood pressure pill slow MS disability?
- Could a simple injection replace an IV for MS treatment?
- Could a common supplement fight fatigue in progressive MS?
- Tears may replace spinal taps for MS diagnosis