Relapsing–Remitting Multiple Sclerosis (RRMS). Multiple sclerosis
Conditions
Interventions
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. Interventio
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoya Bahram pourian
Ahvaz University of Medical Sciences
Outcome results
None listed