Relapsing Multiple Sclerosis
Conditions
Brief summary
The goal of this clinical trial is to evaluate the efficacy and safety\] in \[subjects diagnosed with RMS according to the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS). The main questions it aims to answer are: \[Question 1\] The efficacy of dimethyl fumarate enteric-coated capsules in the treatment of RMS. \[Question 2\] The safety of dimethyl fumarate enteric-coated capsules in the treatment of RMS. Participants will: Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks. The annualized relapse rate (ARR) at Week 48 will be observed.
Interventions
Eligible 50 RMS patients will orally take dimethyl fumarate enteric-coated capsules during treatment, with an initial dose of 120 mg twice daily for 7 days, followed by a maintenance dose of 240 mg twice daily for 48 weeks
Sponsors
Qilu Pharmaceutical (Hainan) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed RMS per the 2017 McDonald criteria, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS) * At least one documented relapse within 12 months prior to screening; plus evidence of MS-consistent lesions on prior brain MRI or gadolinium-enhancing (GdE) lesions on an MRI performed within 6 weeks before screening * Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0 (inclusive) at screening
Exclusion criteria
* History or current diagnosis of malignancy (except fully resected basal cell carcinoma), or uncontrolled severe diseases of major organ systems (e.g., cardiac, renal, hepatic, neurological \[excluding multiple sclerosis\]) that, in the investigator's assessment, pose a significant risk to the subject or could confound study results. * Protocol-defined multiple sclerosis (MS) relapse within 30 days prior to screening, or failure to achieve clinical stability from a prior relapse. * History of suicidal behavior within 5 years prior to screening. Suicidal ideation (indicated by a Yes response to Item 4 or 5 on the C-SSRS) within 6 months prior to screening.Subjects with a history of suicidal behavior occurring \>5 years prior to screening require investigator assessment of eligibility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Relapse Rate at Week 48 | 48 weeks | The primary efficacy endpoint is the annualized relapse rate (ARR), calculated as total relapses divided by total patient-years of observation, measured at Week 48 |
Contacts
Primary ContactJunwei Hao, doctor
Outcome results
None listed