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PrimeC for ALS (PARADIGM Trial)
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.
PARADIGM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPARADIGM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PARADIGM Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: PrimeC
- Group 2: Placebo
- 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
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."
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."
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."
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."
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 ≥"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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