Multiple SclerosisPhase 1/2NCT02212886
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS
A Phase 1/2 study testing GA Depot 80 mg and GA Depot 40 mg in people with Multiple Sclerosis, run by Mapi Pharma Ltd. at 3 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- GA Depot 80 mg and GA Depot 40 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesIsrael
- Study dates
- Oct 2014to 20 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Barzilai Medical Center
Ashkelon
Rambam Medical Center
Haifa
TASMC
Tel Aviv
About this study
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)
- 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
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- GA Depot 80 mg, GA Depot 40 mg
- Keywords
- Glatiramer acetate, Copaxone®, Multiple sclerosis, Relapsing remitting multiple sclerosis, RRMS, GA Depot, Monthly injection
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GA Depot 80 mgDrug
Also called Microspheres containing GA
Recruitment completed
GA Depot 40 mgDrug
Also called Microspheres containing GA
Recruitment completed
| Study group | Role | What they receive |
|---|---|---|
| GA Depot 80mg | Experimental | Monthly IM injection Receives: Drug: GA Depot 80 mg |
| GA Depot 40mg | Experimental | Monthly IM injection Receives: Drug: GA Depot 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety / Adverse events
Number of patients experiencing adverse events and assessments of localized skin reactions at injection sites.
Measured: During the study (1 year treatment)
Secondary outcomes (3)
Efficacy/Change in Relapse Rate
Relapse rate detected during the study compared to relapse rate observed in the 12 months prior to study start.
Measured: During the study (1 year treatment)
Efficacy/Changes in brain MRI
Changes from baseline to end of treatment visit in the number of enhancing lesions and new lesions images of brain MRI
Measured: During the study (1 year treatment)
Efficacy/Changes in EDSS
Change from baseline to end of treatment visit of Expanded Disability Status Scale (EDSS) score.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2017
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mapi Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomo Flechter, M.D, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212886
- Sponsor's protocol ID
- MI GA Depot - 001
- Status last verified
- Dec 2024
- First submitted
- 5 Aug 2014
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02212886
- Acronym / sponsor ID
- MI GA Depot - 001
- Conditions
- Multiple Sclerosis
- Keywords
- Glatiramer acetate, Copaxone®, Multiple sclerosis, Relapsing remitting multiple sclerosis, RRMS, GA Depot, Monthly injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mapi Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA Depot 80mg | Experimental | Drug: GA Depot 80 mgMonthly IM injection |
| GA Depot 40mg | Experimental | Drug: GA Depot 40 mgMonthly IM injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GA Depot 80 mgAlso: Microspheres containing GARecruitment completed | Drug | GA Depot 80mg |
| GA Depot 40 mgAlso: Microspheres containing GARecruitment completed | Drug | GA Depot 40mg |
Primary outcome
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.
3 secondary outcomes
Efficacy/Change in Relapse Rate
Time frame: During the study (1 year treatment)
Efficacy/Changes in brain MRI
Time frame: During the study (1 year treatment)
Efficacy/Changes in EDSS
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomo Flechter, M.D principal investigator
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GA Depot 80 mg and GA Depot 40 mg in people with Multiple Sclerosis, run by Mapi Pharma Ltd. at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety / Adverse events (time frame: During the study (1 year treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.