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PTC857 for Amyotrophic Lateral Sclerosis (ALS)(CARDINALS Trial)
CARDINALS Trial Summary
This trial will study the effects of PTC857 on people with ALS.
- ALS (Amyotrophic Lateral Sclerosis)
CARDINALS Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
CARDINALS Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
CARDINALS Trial Design
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Who is running the clinical trial?
- You have a serious medical condition that could make it unsafe for you to participate in the study.You have taken PTC857 before.You are currently taking both edaravone and sodium phenylbutyrate/taurursodiol together within the last 30 days.If you are a woman, you have had breast cancer before or have a close family member who has had breast cancer.You have been diagnosed with ALS, and it has been less than 24 months since your first symptoms appeared.You have been diagnosed with either definite ALS or probable ALS based on specific criteria.Your ALSFRS-R score needs to be at least 34 at the beginning of the screening period.Your breathing capacity is not significantly reduced, and you can breathe in a normal way.
- Group 1: PTC857
- 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
Has the FDA granted authorization for PTC857?
"Since PTC857 is currently undergoing a Phase 2 trial, our team at Power judged its safety to be at level two. This signifies that while there has been some evidence collected demonstrating the drug's security profile, efficacy data has yet to be produced."
Are there any openings in this research project for participants?
"Per the information on clinicaltrials.gov, this medical study is currently recruiting patients; it was originally posted to the website in mid-May 2021 and has seen its last amendment just a few weeks ago at the end of November 2022."
Does the trial's criteria allow for participants aged 60 and over?
"The eligibility criteria for this medical trial requires potential participants to be aged 18 or older and no more than 80 years old."
How many people are involved in this therapeutic trial?
"This trial necessitates the participation of 258 qualified individuals, who can enroll at one of several sites such as California Pacific Medical Center Research Institute, Sutter Health in San Francisco or Austin Neuromuscular Centre."
How many medical facilities are executing this research experiment?
"Currently, this trial is recruiting from 6 different sites located in San Francisco, Austin and Dallas. In order to reduce travel requirements for those involved, it is important to select the closest site."
Is there any criteria for eligibility to take part in this experiment?
"This clinical trial is in search of 258 participants aged between 18 and 80 who are living with amyotrophic lateral sclerosis."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare: < 48 hours
Average response time
- < 2 Days
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