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PTC857 for Amyotrophic Lateral Sclerosis (ALS)(CARDINALS Trial)

Phase 2
Recruiting
Research Sponsored by PTC Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ALS with preserved function, defined as onset of the first symptom leading to the diagnosis of ALS ≤24 months at the time of the initial Screening Visit
Revised EL Escorial criteria of either clinically definite ALS or clinically probable ALS
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upday 1 through week 52
Awards & highlights

CARDINALS Trial Summary

This trial will study the effects of PTC857 on people with ALS.

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

CARDINALS Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have been diagnosed with ALS, and it has been less than 24 months since your first symptoms appeared.
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You have been diagnosed with either definite ALS or probable ALS based on specific criteria.
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Your ALSFRS-R score needs to be at least 34 at the beginning of the screening period.
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Your breathing capacity is not significantly reduced, and you can breathe in a normal way.

CARDINALS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antilymphocyte Serum
Secondary outcome measures
AUC of PTC857 in Cerebrospinal Fluid (CSF)
Area under the Concentration-time Curve (AUC) of PTC857 in Plasma
Change from Baseline in ALS Assessment Questionnaire (ALSAQ-40) Score at Week 24
+11 more

CARDINALS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PTC857Experimental Treatment1 Intervention
Participants will receive PTC857 during the 24-Week Treatment Period. Following successful completion of the Treatment Period, participants who enter the Long-term Extension (LTE) Period, will receive open-label PTC857 for 28 weeks. Following completion of the LTE period, participants who enter the Continued LTE Period will receive open-label PTC857 for an additional 108 weeks.
Group II: PlaceboActive Control1 Intervention
Participants will receive matching placebo during the 24-Week Treatment Period. Following successful completion of the Treatment Period, participants who enter the LTE Period, will receive open-label PTC857 for 28 weeks. Following completion of the LTE period, participants who enter the Continued LTE Period will receive open-label PTC857 for an additional 108 weeks.

Find a Location

Who is running the clinical trial?

PTC TherapeuticsLead Sponsor
72 Previous Clinical Trials
5,734 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
19 Patients Enrolled for Amyotrophic Lateral Sclerosis
Subha KrishnanStudy DirectorPTC Therapeutics

Media Library

Placebo (Placebo) Clinical Trial Eligibility Overview. Trial Name: NCT05349721 — Phase 2
Amyotrophic Lateral Sclerosis Research Study Groups: PTC857, Placebo
Amyotrophic Lateral Sclerosis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05349721 — Phase 2
Placebo (Placebo) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05349721 — Phase 2
Amyotrophic Lateral Sclerosis Patient Testimony for trial: Trial Name: NCT05349721 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

My friend has been diagnosed with ELA some weeks ago and there is no time to waste. He is optimistic and still in pretty good shape to undertake this trial.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of South Florida - Carol and Frank Morsani Center for Advanced Healthcare: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALS
2022. "Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349721.
All > Lou Gehrigs Disease > Als
~79 spots leftby Jul 2024
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