Coya 302 in ALS Assessment (Animal/Cell Study)
A study involving 120 participants is investigating the drug COYA 302 against a placebo over 24 weeks to evaluate its impact on disease progression in Amyotrophic Lateral Sclerosis (ALS) using various clinical measures, although results are not yet available.
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- #MSResearch
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- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
This research is essential as it aims to identify potential effects of COYA 302 on disease progression, contributing to the understanding and management of ALS.
What this does not prove
No results from the study are posted, and planned enrolment and endpoints do not provide conclusive findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 120 · basis not reported
- Randomised
- Yes
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Yes
- Research areas
- Not classified
Original sources
- Trial registrationStudy of COYA 302 for the Treatment of ALS ↗
Supporting passages (10)
study design"studyType": "INTERVENTIONAL"
sample size"count": 120, "type": "ESTIMATED"
randomized"allocation": "RANDOMIZED"
regulatory approval"isFdaRegulatedDrug": true
intervention"Drug: COYA 302"
comparator"Drug: Placebo"
primary endpoint"measure": "The change in disease progression as measured by the Revised ALS Functional Rating Scale (ALSFRS-R)"
follow up"timeFrame": "Baseline to Week 24"
findingsUpon completion of the EXT phase of the study, participants will be invited to participate in an open label extension (OLE).\n\nThe study will assess changes in disease progression using established ALS clinical outcome measures, including the ALS Functional Rating Scale-Revised (ALSFRS-R), neurofilament (NfL), maximal inspiratory pressure (MIP), slow vital capacity (SVC), and neurological assessments.
limitationsPlanned enrolment and endpoints are not findings.
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