PrimeC for ALS

(PARADIGM Trial)

Recruiting at 5 trial locations

Overseen By Ferenc Tracik

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NeuroSense Therapeutics Ltd.

Must be taking: Riluzole, Edaravone

Must not be taking: NSAIDs, Celecoxib

Disqualifiers: Heart disease, Renal impairment, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 months

69 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial allows participants to continue taking certain ALS treatments like riluzole, edaravone, sodium phenylbutyrate, and taurursodiol if they have been stable on them for at least 60 days before joining. However, if you are on chronic aspirin or NSAIDs and stopping them would be risky, you may not be eligible to participate.

What is the purpose of this trial?

This trial involves ALS patients who will receive a new drug. The goal is to see if the new drug is safe, well-tolerated, and effective in improving their condition. Participants' health will be monitored regularly.

Eligibility Criteria

This trial is for adults aged 18-75 with ALS, who can understand and agree to the study terms. They must have an ALSFRS-R score ≥25, stable swallowing ability, a BMI between 18-30, disease duration less than 30 months from first symptom, and meet specific breathing capacity criteria. Women must meet reproductive standards. Exclusions include severe diabetes, heart issues, renal impairment, cognitive problems or other significant illnesses.

Inclusion Criteria

Your ALSFRS-R score at screening needs to be 25 or higher.

I can swallow without significant difficulty.

Your ALS symptoms have been getting worse by 0.3 points or more each month since they started.

Exclusion Criteria

My kidney function is impaired with high creatinine levels.

I use a tracheostomy or feeding tube.

I am a poor metabolizer for certain medications due to my CYP2C9 status.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study drug or placebo twice daily for 6 months

6 months

Evaluations every 2 months for safety, tolerability, and efficacy

Open-label extension

Participants who complete the initial treatment phase switch to the active arm for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PrimeC

Trial Overview The study tests PrimeC against a placebo in people with ALS. Participants are randomly assigned in a 2:1 ratio to either receive PrimeC or placebo twice daily for six months while continuing standard treatments like riluzole and edaravone. After six months of treatment, all participants will receive PrimeC during a year-long open label extension phase.

Participant Groups

Group I: PrimeC Active Control 1 Intervention

2 tablets of PrimeC administered twice daily (4 tablets a day), at a daily dose of 1496 mg

Group II: Placebo Placebo Group 1 Intervention

2 tablets of Placebo administered twice daily (4 tablets a day). Placebo tablets are matched in size, color and taste.

Who Is Running the Clinical Trial?

NeuroSense Therapeutics Ltd.

Lead Sponsor

Trials

6

Recruited

150+