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PrimeC for ALS (PARADIGM Trial)
Phase 2
Waitlist Available
Research Sponsored by NeuroSense Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Item 3 (swallowing) in ALSFRS-R ≥ 3
Upright slow vital capacity (SVC) ≥ 60% of predicted for age, height, weight and sex at screening according to the GLI-2012
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
PARADIGM Trial Summary
This trialwill study a drug for ALS in 69 people. They'll take it twice a day for 6 months and have safety and efficacy tests over that time. 12 more months of testing to follow.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects of PrimeC are not detailed here specifically since it's under investigation; generally such trials monitor for adverse reactions including digestive issues, allergic responses to medication components if known allergies exist and potential interactions with existing medications.
PARADIGM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow without significant difficulty.
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My lung function test shows I'm at least 60% of the expected value for my age, height, weight, and sex.
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I have been diagnosed with ALS.
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I meet the specific reproductive health requirements.
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I have been on stable medication for at least 60 days before joining.
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I am between 18 and 75 years old.
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My muscle weakness started less than 30 months ago.
PARADIGM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of treatment-emergent adverse events (TEAEs)
Number of patients who discontinued treatment prematurely due to adverse events
Number of patients with clinically significant abnormal laboratory values
+3 moreSecondary outcome measures
Change from baseline to 6 months in ALS functional rating scale - revised (ALSFRS-R)
Change from baseline to 6 months in PROMIS-10 quality of life questionnaire
Change from baseline to 6 months in quality of life ALSSQOL-SF
+4 moreOther outcome measures
Change from baseline to 6 months in Patient-ranked order of function (PROOF)
Change from baseline to 6 months in the following serum biomarkers: serum ferritin, transferrin, iron, neurofilaments and exosomal LC3, Dicer, and other biomarkers evaluating the effect of PrimeC on pathophysiological mechanisms in ALS
Effect of PrimeC versus placebo on the time to reach advanced disease stages (King's/MiToS)
PARADIGM Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: PrimeCActive Control1 Intervention
2 tablets of PrimeC administered twice daily (4 tablets a day), at a daily dose of 1496 mg
Group II: PlaceboPlacebo Group1 Intervention
2 tablets of Placebo administered twice daily (4 tablets a day). Placebo tablets are matched in size, color and taste.
Find a Location
Who is running the clinical trial?
NeuroSense Therapeutics Ltd.Lead Sponsor
5 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your ALSFRS-R score at screening needs to be 25 or higher.My kidney function is impaired with high creatinine levels.I can swallow without significant difficulty.I use a tracheostomy or feeding tube.I am a poor metabolizer for certain medications due to my CYP2C9 status.Your ALS symptoms have been getting worse by 0.3 points or more each month since they started.Your body mass index (BMI) is between 18 and 30.I have difficulty with memory or thinking clearly.I have a serious stomach issue, like an ulcer, tumor, or I've had weight loss surgery.I have a serious heart, lung, muscle, or mental health condition.I have heart problems like heart failure, heart attack, high blood pressure, or irregular heartbeat.My blood pressure and heart function meet the study's requirements.My lung function test shows I'm at least 60% of the expected value for my age, height, weight, and sex.I am currently pregnant, breastfeeding, or planning to become pregnant.I have been diagnosed with ALS.I meet the specific reproductive health requirements.I have a history of heart rhythm issues or epilepsy.I have been on stable medication for at least 60 days before joining.My diabetes is hard to control or fluctuates a lot.I am between 18 and 75 years old.I cannot take certain medications due to adverse reactions.I understand what participating in this study involves.I regularly use aspirin or NSAIDs.You are prone to getting tendinitis.I have a condition or situation that makes it hard for me to join the study.I use daily medication for my COPD or asthma.My muscle weakness started less than 30 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: PrimeC
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap on participants in this clinical trial?
"Affirmative, the clinical trial hosted on clinicaltrials.gov is actively searching for participants. This medical study was first announced on May 31st 2022 and modified most recently on November 23rd 2022. To be successful, 69 volunteers must be recruited from 2 distinct sites."
Answered by AI
Does this research protocol currently have room for additional participants?
"The clinical trial is currently in its recruitment phase, as denoted on the clinicaltrials.gov website. The initial listing was posted on May 31st 2022 and has been updated most recently on November 23rd 2022."
Answered by AI
Does the FDA recognize PrimeC as a viable treatment option?
"The risk profile associated with PrimeC is scored at a 2, as the compound has yet to demonstrate efficacy in clinical trials despite having some preliminary data regarding safety."
Answered by AI
Does this clinical investigation accept participants aged 18 or older?
"To be qualified for this research program, participants must be of legal age and no older than 75 years."
Answered by AI
What are the qualifications to participate in this experiment?
"This research trial seeks 69 individuals with amyotrophic lateral sclerosis (ALS) aged between 18 and 75. Each participant must meet certain criteria, such as: Item 3 (swallowing) in ALSFRS-R ≥3, Upright slow vital capacity (SVC) ≥60% of predicted for age, height, weight and sex at screening according to the GLI-2012; BMI between 18 < 30; Diagnosis of familial or sporadic ALS determined by the Gold Coast Criteria; Disease duration after first symptom not exceeding 30 months prior to screening; Pre-enrollment ALSFRS-R slope from disease onset ≥"
Answered by AI
Who else is applying?
What site did they apply to?
Loma Linda University Health Care
What portion of applicants met pre-screening criteria?
Met criteria
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