PrimeC for ALS
(PARADIGM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called PrimeC for people with ALS, a condition affecting nerve cells in the brain and spinal cord, leading to muscle weakness. The trial compares PrimeC to a placebo (a pill with no active ingredient) over six months to assess its safety and effectiveness. Those with ALS who have had symptoms for less than 30 months and experience muscle weakness may be suitable for this study. Participants will take four tablets a day and can continue using other ALS treatments if they have been stable on them for at least 60 days before joining. After six months, all participants will receive the actual treatment for another year to further evaluate its benefits. As a Phase 2 trial, this research measures how well PrimeC works in an initial, smaller group of people, offering participants a chance to contribute to important ALS treatment advancements.
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.
Is there any evidence suggesting that PrimeC is likely to be safe for humans?
Research has shown that PrimeC has met safety and tolerability goals in studies. PrimeC combines two FDA-approved drugs: ciprofloxacin and celecoxib. Tests have assessed how well people can handle this combination. Studies found no major safety issues, and participants generally tolerated the treatment well.
Promising data also indicate that PrimeC positively affects certain biological markers, which could benefit people with ALS. These results support the short-term safety of PrimeC.
As further testing continues, researchers will closely monitor any new safety information. Prospective trial participants may find this background reassuring regarding the safety of PrimeC.12345Why do researchers think this study treatment might be promising?
Most treatments for ALS, like riluzole and edaravone, work by slowing the progression of the disease or reducing oxidative stress. But PrimeC works differently, targeting multiple pathways involved in ALS. It combines two active ingredients, ciprofloxacin and celecoxib, which aim to reduce inflammation and protect nerve cells. Researchers are excited about PrimeC's potential to offer a more comprehensive approach to managing ALS, possibly improving both survival and quality of life for patients.
What evidence suggests that PrimeC might be an effective treatment for ALS?
Research has shown that PrimeC, which participants in this trial may receive, may help slow the progression of ALS (amyotrophic lateral sclerosis). In one study, individuals taking PrimeC experienced a 36% slower progression of the disease compared to those who initially received a placebo (a non-active treatment) and then switched to PrimeC. Another study found a similar result, with a 32.8% reduction in the rate of disease progression. Additionally, lab tests on ALS models demonstrated that PrimeC improved the survival of motor neurons, the nerve cells affected by ALS. PrimeC also met important safety and effectiveness goals in earlier studies, showing benefits for both function and survival in people with ALS.12678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study drug or placebo twice daily for 6 months
Open-label extension
Participants who complete the initial treatment phase switch to the active arm for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PrimeC
Find a Clinic Near You
Who Is Running the Clinical Trial?
NeuroSense Therapeutics Ltd.
Lead Sponsor