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Protein Replacement Therapy
CTI-1601 for Friedreich's Ataxia
Phase 2
Waitlist Available
Led By Magdy Shenouda, M.D.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 93 days
Awards & highlights
Study Summary
This trial will evaluate if a medicine is safe/well-tolerated, and its effects on Friedreich's ataxia over 28 days.
Eligible Conditions
- Friedreich Ataxia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 93 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 93 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Area under the concentration time curve (AUC) of CTI-1601 from time 0 through the last measurable time point
Changes from baseline in frataxin levels in buccal cells
Cells
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CTI-160lExperimental Treatment1 Intervention
CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia
Group II: PlaceboPlacebo Group1 Intervention
Placebo Comparator
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
4 Previous Clinical Trials
135 Total Patients Enrolled
4 Trials studying Friedreich Ataxia
135 Patients Enrolled for Friedreich Ataxia
Magdy Shenouda, M.D.Principal InvestigatorClinilabs, Inc.
2 Previous Clinical Trials
87 Total Patients Enrolled
2 Trials studying Friedreich Ataxia
87 Patients Enrolled for Friedreich Ataxia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity, as measured by an ECG, is too slow.You take more than 3.0 grams of acetaminophen every day.You need to take amiodarone.You have taken omaveloxolone within the last 30 days before screening.You are taking a medication that needs to be injected under the skin in your belly or thigh.You have a specific genetic mutation related to Friedreich's ataxia.You have a confirmed genetic diagnosis of FRDA with specific GAA repeat expansions.You have taken more than 30.0 mcg/day of biotin (found in some multivitamins or standalone supplements) within 7 days before starting the study drug.Your heart's pumping ability, measured by a screening test called ECHO, is less than 45%.You have taken erythropoietin, etravirine, or gamma interferon in the 90 days before the screening.
Research Study Groups:
This trial has the following groups:- Group 1: CTI-160l
- 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.
Are any fresh volunteers currently being accepted for this research?
"Affirmative. The information hosted on clinicaltrials.gov verifies that this particular medical experiment is actively accepting volunteers, having been posted on September 21st 2022 and recently updated on October 11th 2022. 15 subjects are sought from 1 site for enrolment in the trial."
Answered by AI
Has the FDA officially validated CTI-160l?
"Considering the nature of this Phase 2 trial, wherein safety has been demonstrated but efficacy remains unknown, our team at Power have assigned CTI-160 a score of 2 on their scale from 1 to 3."
Answered by AI
What is the projected sample size for this clinical research?
"Affirmative, clinicaltrials.gov hosts evidence that this medical survey is presently in the process of recruiting participants. It was opened for enrollment on September 21st 2022 and edited most recently on October 11th 2022. Fifteen patients have to be enrolled from 1 site."
Answered by AI
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