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Cancer Vaccine
CTI-1601 for Friedreich's Ataxia (Jive Trial)
Phase 2
Waitlist Available
Research Sponsored by Larimar Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Subject requires use of amiodarone
Subjects who are confirmed as compound heterozygous (GAA repeat expansion on only one allele) for FRDA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at the long-term effects of giving CTI-1601, a medication, to people with Friedreich's ataxia. The study aims to see if the medication is safe
Who is the study for?
This trial is for individuals with Friedreich's Ataxia, a genetic movement disorder. Participants must have completed a prior CTI-1601 study to join this extension and continue evaluating the drug's effects.
What is being tested?
The trial tests long-term safety and effects of CTI-1601, administered under the skin, on disease symptoms, gene expression, and specific lipid levels in patients with Friedreich's Ataxia.
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, potential allergic responses to components of CTI-1601 or general discomfort.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need to take amiodarone for my condition.
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I have a specific genetic form of Friedreich's ataxia.
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My heart's electrical activity (QTcF) is within a safe range.
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I have not used erythropoietin, etravirine, or gamma interferon in the last 90 days.
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I take more than 3 grams of acetaminophen daily.
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I take medication that is injected into my abdomen or thigh.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in left ventricular ejection fraction (LVEF)
Change from baseline in left ventricular end-diastolic volume (LVEDV)
Change from baseline in neurologic function as assessed by the modified Friedreich's Ataxia Rating Scale (mFARS) total score
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CTI-1601Experimental Treatment1 Intervention
CTI-1601 will be administered daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CTI-1601
2020
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Larimar Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
193 Total Patients Enrolled
6 Trials studying Friedreich Ataxia
193 Patients Enrolled for Friedreich Ataxia