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.
* 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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)
Once-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot)
Mapi Pharma Research site 09
Haifa, Israel
Mapi Pharma Research site 07
Jerusalem, Israel
Mapi Pharma Research site 08
Petah Tikva, Israel
Mapi Pharma Research site 06
Rehovot, Israel
Safety (Adverse Events and Injection Site Reactions)
Assessment of Adverse events (AEs) \& Injection Sites Reactions (ISRs)
Time frame: 152 weeks
Efficacy (Confirmed Disease Progression)
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.
Time frame: 148 weeks
Efficacy (Whole brain volume change)
MRI assessment of percent of whole brain volume change.
Time frame: 148 weeks
Efficacy (Cortical volume change)
MRI assessment of percent of cortical volume change.
Time frame: 148 weeks
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Mapi Pharma Research site 01
Tel Aviv, Israel
Mapi Pharma Research site 20
Chisinau, Moldova
Mapi Pharma Research site 22
Chisinau, Moldova