Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects Wit… (NCT03362294) | Clinical Trial Compass
TerminatedPhase 2
Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS
Stopped: The study was terminated early as part of a global realignment of Sponsor's clinical development programs. This decision is not related to any safety concerns regarding the IP.
Israel30 participantsStarted 2017-12-11
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female subjects diagnosed with PPMS; Diagnosis of PPMS consistent with the McDonald Criteria (revisions of 2010).
✓. Age between 18 and 65 years (inclusive).
✓. 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.
✓. EDSS ≥2 and ≤ 6.5 (Pyramidal or Cerebellar FS ≥ 2).
✓. 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).
✓. Women of child bearing potential must have a negative urine pregnancy test at screening and use an adequate contraceptive method throughout the study.
✓. Ability to provide written informed consent.
Exclusion criteria
✕. Subjects with RRMS, SPMS, or PRMS.
What they're measuring
1
Safety (Adverse Events and Injection Site Reactions)
✕. Subjects with a documented history of clinical relapse events.
✕. 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.
✕. Contraindications or inability to successfully undergo magnetic resonance imaging (MRI) scanning.
✕. 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.
✕. Severe anemia (hemoglobin \<10 g/dL).
✕. Abnormal renal function (serum creatinine \>1.5xULN or creatinine clearance \<30 ml/min).
✕. Abnormal liver function (transaminases \>2xULN).