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 : August 16, 2021
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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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)|
|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|
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)
- Safety (Adverse Events and Injection Site Reactions) [ Time Frame: 152 weeks ]Assessment of Adverse events (AEs) & Injection Sites Reactions (ISRs)
- 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.
- Efficacy (Whole brain volume change) [ Time Frame: 148 weeks ]MRI assessment of percent of whole brain volume change.
- Efficacy (Cortical volume change) [ Time Frame: 148 weeks ]MRI assessment of percent of cortical volume change.
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
|Mapi Pharma Research site 09||Recruiting|
|Contact: Svetlana Afanasiev +972 4 7771926 firstname.lastname@example.org|
|Mapi Pharma Research site 07||Recruiting|
|Contact: Keren Dambinsky 02-6777716 email@example.com|
|Mapi Pharma Research site 08||Recruiting|
|Petah tikva, Israel|
|Contact: Yaniv Rodity 03-6528734 firstname.lastname@example.org|
|Mapi Pharma Research site 06||Recruiting|
|Contact: Shiran Rogof 08-9441364 email@example.com|
|Mapi Pharma Research site 01||Recruiting|
|Tel Aviv, Israel|
|Contact: Irina Komarov 03-6974380 firstname.lastname@example.org|
|Moldova, Republic of|
|Mapi Pharma Research site 20||Recruiting|
|Chisinau, Moldova, Republic of|
|Contact: Mihail Gavriliuc, MD +37322205383 email@example.com|
|Mapi Pharma Research site 22||Recruiting|
|Chisinau, Moldova, Republic of|
|Contact: Olesea Odainic, MD +37379443354 firstname.lastname@example.org|
|Principal Investigator:||Arnon Karni, MD||Coordinating PI|