Safety and Effectiveness of Cinnomer® (Glatiramer Acetate) in Multiple Sclerosis (MS) Treatment in Iran
NCT ID: NCT04928313
Last Updated: 2021-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
368 participants
OBSERVATIONAL
2015-04-12
2020-02-17
Brief Summary
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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
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Detailed Description
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The primary objective of this study was safety evaluation. To evaluate the safety of Cinnomer®, at each visit, the AEs, seriousness of observed AEs, and abnormal laboratory findings were recorded.
To evaluate the effectiveness of Cinnomer® as the secondary objective, the indicative parameters of MS activity, including relapse information, MRI findings, and EDSS scores were considered. Also, questionnaires assessing the patients' QoL and depression were evaluated.
The sample size of 368 patients and the 14 months of the study was considered applicable for safety and effectiveness evaluation of Cinnomer®, 40 mg/ml, three times per week, in patients with relapsing forms of MS.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Glatiramer Acetate
Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* In the investigator's opinion, any reason that makes the subject unsuitable for treatment with Cinnomer®.
18 Years
60 Years
ALL
No
Sponsors
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Cinnagen
INDUSTRY
Responsible Party
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Principal Investigators
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Abdorreza Naser Moghadasi, Assistant Professor
Role: PRINCIPAL_INVESTIGATOR
Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran
Other Identifiers
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CINNOMER.CIN.AN.94 (IV)
Identifier Type: -
Identifier Source: org_study_id
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