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IRCT20260202068737N1 IRCT 2026-02-05 Ahvaz University of Medical Sciences A Clinical Trial Comparing Gastrointestinal Tolerability of Diroximel Fumarate and Dimethyl Fumarate in Patients with RRMS Gastrointestinal Tolerability of Diroximel Fumarate Compared with Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis: Clinical Trial Study 2026-03-20 anticipated 40 Complete https://irct.ir/trial/88959 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After confirming eligibility criteria and obtaining written informed consent, eligible patients will be randomly assigned in a 1:1 allocation ratio to receive either diroximel fumarate (DRF) or dimethyl fumarate (DMF). Randomization will be performed by a statistician using a random number table or validated statistical software (such as SPSS or R). To minimize selection bias and ensure balance of baseline characteristics between the two treatment groups, treatment allocation will be conducted in an unpredictable manner. Given the open-label design of the study, both investigators and participants will be aware of the assigned treatment. 4 Relapsing–Remitting Multiple Sclerosis (RRMS). Intervention 1: Intervention group: The first group receives diroximel fumarate (DRF) with a dose of 231 mg twice daily during the first week, and 462 mg twice daily from week 2 to week 5. Intervention 2: Intervention group: The second group receives dimethyl fumarate (DMF) with a dose of 120 mg twice daily during the first week, and 240 mg twice daily from week 2 to week 5. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No information
public Roya Bahram pourian
Ahvaz, Ostadan Quay, West Coast Boulevard, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) ۶۱۱۳۵۱۳۱۱۱ +98 61 3311 1565 bahrampourian.roya67@gmail.com Ahvaz University of Medical Sciences scientific Roya Bahram pourian
Ahvaz, Ostadan Quay, West Coast Boulevard, Golestan Boulevard
Ahvaz Iran (Islamic Republic of) ۶۱۱۳۵۱۳۱۱۱ +98 61 3311 1565 bahrampourian.roya67@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) A confirmed diagnosis of relapsing–remitting multiple sclerosis (RRMS) according to the McDonald criteria Age between 18 and 65 years at the time of study entry. Not pregnant or breastfeeding at screening, with agreement to use effective contraception during the study period No history of hypersensitivity or severe adverse reactions to fumarates or related compounds. No active or clinically significant gastrointestinal disease that could interfere with drug tolerability assessment No active or clinically significant gastrointestinal disease that could interfere with drug tolerability assessment No severe hepatic or renal impairment based on medical history, physical examination, and baseline laboratory evaluations. Acceptable baseline laboratory values, including hematologic and biochemical parameters. No diagnosis of progressive forms of multiple sclerosis. No prior treatment with dimethyl fumarate or switching from DMF to DRF before screening. Willingness and ability to complete daily study questionnaires throughout the follow-up period. Provision of written informed consent prior to enrollment and randomization. 18 years 65 years Both G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: The first group receives diroximel fumarate (DRF) with a dose of 231 mg twice daily during the first week, and 462 mg twice daily from week 2 to week 5 Intervention group: The second group receives dimethyl fumarate (DMF) with a dose of 120 mg twice daily during the first week, and 240 mg twice daily from week 2 to week 5 Drug gastrointestinal tolerability, measured by IGISIS and GGISIS scales. This variable includes assessment of the occurrence, severity, duration, and functional impact of key gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhea during the 5-week treatment period. Timepoint: Measurements and assessments will be conducted daily from the first day of treatment (week 1) through the end of week 5 (day 35). Additionally, safety follow-ups and adverse event monitoring will continue for two weeks after the treatment period. Method of measurement: The primary outcome, gastrointestinal tolerability, is measured using two validated questionnaires: IGISIS (Individual Gastrointestinal Symptom and Impact Scale) and GGISIS (Global Gastrointestinal Symptom and Impact Scale). Patients report the severity of gastrointestinal symptoms—including nausea, vomiting, upper and lower abdominal pain, and diarrhea—daily on a numerical scale from 0 to 10. Additionally, the duration of symptoms and their impact on daily activities are recorded. These questionnaires are completed daily, and the data are collected for statistical analysis. Treatment adherence: The extent of continued drug use and the number of doses taken during the 5-week period. Timepoint: Measurements and assessments will be conducted daily from the first day of treatment (week 1) through the end of week 5 (day 35). Additionally, safety follow-ups and adverse event monitoring will continue for two weeks after the treatment period. Method of measurement: The primary outcome, gastrointestinal tolerability, is measured using two validated questionnaires: IGISIS (Individual Gastrointestinal Symptom and Impact Scale) and GGISIS (Global Gastrointestinal Symptom and Impact Scale). Patients report the severity of gastrointestinal symptoms—including nausea, vomiting, upper and lower abdominal pain, and diarrhea—daily on a numerical scale from 0 to 10. Additionally, the duration of symptoms and their impact on daily activities are recorded. These questionnaires are completed daily, and the data are collected for statistical analysis. Health-related quality of life (HRQoL): Assessed by the SF-36 questionnaire at baseline and at the end of treatment, including physical (PCS) and mental (MCS) component summaries. Timepoint: Measurements and assessments will be conducted daily from the first day of treatment (week 1) through the end of week 5 (day 35). Additionally, safety follow-ups and adverse event monitoring will continue for two weeks after the treatment period. Method of measurement: Health-related quality of life (HRQoL) is assessed using the standardized SF-36 questionnaire at baseline and at the end of the treatment period. The questionnaire covers 8 domains, with scores ranging from 0 to 100 for each domain. Two main summary components, Physical Component Summary (PCS) and Mental Component Summary (MCS), are derived from the questionnaire. Higher scores indicate better quality of life. Ahvaz University of Medical Sciences Approved 2026-01-30 Research Ethics Committee of the University Block 4 (Unit Golestan 4), Golestan Hospital, Golestan Street, Golestan Town, Ahvaz, Khuzestan Province, Iran Ahvaz Jundishapur University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)