NCT05357950Phase 2Completed

A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

Study sponsor: NeuroSense Therapeutics Ltd. · NRSN

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-11-02Actual

Enrollment · participants69Actual

Source updated2025-09-05Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Amyotrophic Lateral Sclerosis; ALS

Treatments or interventions studied

PrimeCDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: Incidence and severity of treatment-emergent adverse events (TEAEs); description: Treatment emergent adverse event is any medical event associated with the drug; timeFrame: 6 months; measure: Number of subjects who discontinued treatment prematurely; description: Number of subjects whose treatment is stopped prematurely for any reason; timeFrame: 6 months; measure: Number of patients who discontinued treatment prematurely due to adverse events; description: Number of patients whose treatment is stopped prematurely specifically due to adverse events; timeFrame: 6 months; measure: Number of patients with clinically significant abnormal laboratory values; timeFrame: 6 months; measure: The mean difference between PrimeC and Placebo in serum concentration of NDE TDP-43 at month 6; timeFrame: 6 months; measure: The mean difference between PrimeC and placebo in serum concentration of NDE PgJ2 at month 6; timeFrame: 6 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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