Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
What it found
We found no results in the registry or in papers.
This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
What it measured
Main measures
Safety assessment
Throughout the study period (up to 14 months for each patient)
Safety
Other measures (6)
Change from Baseline in Annualized Relapse Rate
Baseline, Month 14
RelapsesThe proportion of relapse-free patients
Baseline, Month 14
RelapsesChange from Baseline in Expanded Disability Status Scale (EDSS)
Baseline, Month 14
Disability progressionChange in Mean Number of T2 and Gd-enhancing lesions
Baseline, Month 14
MRI lesionsChange From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Questionnaire Scale Score at Month 14
Baseline, Month 14
Quality of life (reported by participants)Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score at month 14
Baseline, Month 14
Mood and sleep
Who could take part
Relapsing and progressive · 18 to 60
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®.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Loading reviews and guidelines…
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History
Started
Apr 2015
Main results due
Feb 2020
Finished
Feb 2020
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