Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
Sponsored by Cinnagen
About this trial
Last updated 4 years ago
Study ID
CINNOMER.CIN.AN.94 (IV)
Status
Completed
Type
Observational
Placebo
No
Accepting
18 to 60 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 5 years ago
What is this trial about?
This trial was an obsevational phase IV prospective multicenter study designed to
evaluate the safety and effectiveness of Cinnomer® in patients with MS in Iran.
The primary objective of this study was safety assessment of Cinnomer®
Secondary objectives were:
- Effectiveness assessment of Cinnomer®
- Assessment of the patients' QoL
- Evaluation of the patients' depression status
What are the participation requirements?
Inclusion Criteria
- Patients with RRMS
- Patients diagnosed as SPMS with relapse
- All the patients taking other DMTs and their medication had been changed to Cinnomer® due to any reason.
- 0 ≤ EDSS ≤ 5
- 18 ≤ Age ≤ 60
Exclusion Criteria
- History of hypersensitivity to Glatiramer Acetate, mannitol, or any component of the formulation.
- In the investigator's opinion, any reason that makes the subject unsuitable for treatment with Cinnomer®.