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Research summary · AI summary · not yet reviewedHuman studyPhase 1/2Trial registry
Human Subjects: Safety and Efficacy Study of PRO-1562 in Multiple Sclerosis
A Phase 1/2 study is evaluating the oral drug PRO-1562. Phase 1 focuses on safety and pharmacokinetics in healthy adults, while Phase 2a will investigate its efficacy for remyelination in RMS patients with chronic optic neuropathy over 6 months.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
Understanding the safety and efficacy of PRO-1562 could provide new options for treating relapsing MS and related vision issues, significantly impacting patient care.
What this does not prove
The study has not reported results yet, and details on planned enrollment and endpoints are not definitive, limiting conclusions about the findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (9)
study phaseA Phase 1/2a Study of Oral PRO-1562 in Healthy Subjects and Patients With Relapsing Multiple Sclerosis
study designA Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Trial of PRO-1562 in Healthy Adults and Adults With Multiple Sclerosis and Chronic Optic Neuropathy
subjectsPhase 1 will test single oral doses of PRO-1562 in healthy adult subjects to characterize the safety and the amount of drug that is absorbed into the body.
controlledPhase 2a is a randomized, double-blind, placebo-controlled, multi-center, 6-month trial of PRO-1562 in adult patients with relapsing multiple sclerosis who also have chronic optic neuropathy.
peer reviewedNo results are posted.
relevant ms typesSome subjects will have lumbar punctures performed to measure the amount of drug that crosses the blood-brain barrier since that is the site of drug activity.\n\nPhase 2a will be a 6-month trial to test the ability of once monthly dosing of PRO-1562 to promote remyelination of the CNS and provide clinical benefit to adult patients with relapsing multiple sclerosis (RMS) who also have long-term vision problems diagnosed as chronic optic neuropathy.
interventionOral PRO-1562 or placebo will be dosed once a month at scheduled clinic visits.
findings"briefSummary": "Phase 1 will test single oral doses of PRO-1562 in healthy adult subjects to characterize the safety and the amount of drug that is absorbed into the body.
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
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