Safety and Efficacy of Monthly Long-acting IM Injection of 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 : July 31, 2018
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 52 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||Phase 2|
- 12 to 24 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 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.
- Vital signs and safety assessment will be performed at each visit during the study.
- Physical examination will be performed at screening, baseline, weeks 5, 12, 24, 36, 52 (end of study) and follow up visit.
- MRI will be performed at screenings, week 24 and week 52 (end of study).
- Safety laboratory tests will be performed at screening visit, baseline, weeks 4, 12, 24, 36 and 52 (end of study).
- Neurological assessment will be performed at screening visit, baseline, weeks 12, 24, 36 and 52 (end of study).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Single Arm, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 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 2019|
|Estimated Study Completion Date :||December 2019|
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)
- Safety (Adverse Events and Injection Site Reactions) [ Time Frame: 56 weeks ]Assessment of Adverse events (AEs) & Injection Sites Reactions (ISRs)
- Efficacy (Confirmed Disease Progression) [ Time Frame: 52 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: 52 weeks ]MRI assessment of percent of whole brain volume change.
- Efficacy (Cortical volume change) [ Time Frame: 52 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
|Contact: Nir Michal 08-6745036 firstname.lastname@example.org|
|Principal Investigator: Ron Milo, MD|
|Assaf Harofeh MC||Recruiting|
|Be'er Ya'aqov, Israel|
|Contact: Shlomo Flecther, MD 08-9779879 email@example.com|
|Principal Investigator: Shlomo Flecther, MD|
|Bnai Zion MC||Recruiting|
|Contact: Luda Mazarib 052-2794800 firstname.lastname@example.org|
|Principal Investigator: Boaz Weller, MD|
|Contact: Mary Israelson 050-7704618 email@example.com|
|Principal Investigator: Marieta Anca, MD|
|Contact: Ayelet Sherman 08-9441051 ext 2051 AyeletGo@clalit.org.il|
|Principal Investigator: Ronit Gilad, Prof.|
|Tel Aviv Sourasky MC||Recruiting|
|Tel Aviv, Israel|
|Contact: Michal Shenhaut 03-6974380 firstname.lastname@example.org|
|Principal Investigator: Arnon Karni, MD|
|Principal Investigator:||Arnon Karni, MD||Coordinating PI|