Safety and Tolerability of Terfenadine Added to Standard Therapy in MS (Planned Study)
An interventional study planned to assess the safety and tolerability of terfenadine (60 mg daily) when combined with standard first-line MS therapy in 100 participants. The study is randomized and controlled, with a follow-up of 12 months to evaluate the outcomes of the treatment.
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Why it matters
This study aims to explore whether terfenadine can be safely added to existing treatments for relapsing-remitting multiple sclerosis, potentially widening treatment options if deemed effective.
What this does not prove
No results have been posted; planned enrolment and endpoints are not actual findings and thus do not provide conclusions.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 100 · Estimated
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Not classified
Original sources
Supporting passages (14)
study phase"phases": [ "PHASE2" ]
study design"studyType": "INTERVENTIONAL"
sample size"count": 100
sample size basis"type": "ESTIMATED"
randomized"allocation": "RANDOMIZED"
controlled"type": "ACTIVE_COMPARATOR"
regulatory approval"isFdaRegulatedDrug": false
relevant ms types"description": "Participants will receive standard first-line disease-modifying therapy for relapsing-remitting multiple sclerosis according to routine clinical practice.",
intervention"description": "Terfenadine will be administered orally at a dose of 60 mg once daily at bedtime for 1 month as add-on therapy to standard first-line disease-modifying therapy.",
comparator"Standard First-line Disease-Modifying Therapy Alone",
primary endpoint"Safety and tolerability of terfenadine during the treatment period"
follow up"description": "Participants will receive standard first-line disease-modifying therapy alone according to routine clinical practice and will be followed for 12 months.",
findings"briefSummary": "The goal of this clinical trial is to evaluate the safety and tolerability of terfenadine when added to standard first-line disease-modifying therapy in adults with multiple sclerosis.
limitationsPlanned enrolment and endpoints are not findings.
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