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NCT06447025 · ClinicalTrials.gov registry record · Phase 2

An Open-Label Study of CTI-1601 in Subjects With Friedreich's Ataxia

A Phase 2 study, sponsored by Larimar Therapeutics.

Recruiting
Registry status
Phase 2
Development phase
85
Enrollment target

NCT06447025: Recruiting Phase 2 study, sponsored by Larimar Therapeutics.

NCT06447025 is a Phase 2 study that is actively recruiting participants, run by Larimar Therapeutics. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06447025, a Phase 2 study, is actively recruiting participants, sponsored by Larimar Therapeutics.

RECRUITING
Registry status
Phase 2
Development phase
85 participants
Enrollment target

Study Summary

An open label study designed to evaluate the safety, PK, PD, and clinical effects of long-term daily administration of CTI-1601 enrolling adolescent and adult patients with FRDA who have participated in a prior clinical study of CTI-1601 as well as children (age 2 years and older), adolescents and adults with FRDA who have not participated in a prior clinical study of CTI-1601.

Primary Outcome

Number of subjects

Interventions

  • DRUG CTI-1601

Trial Details

FieldValue
Enrollment Target 85 participants
Start Date 2024-01-25
Est. Completion 2027-01
Phase Phase 2
Larimar Therapeutics

7 total trials

What NCT06447025 shows while recruiting

NCT06447025 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).

The record links to 0 conditions, and to 1 intervention - of which CTI-1601 is the first listed.

NCT06447025 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06447025 about?

NCT06447025 is a clinical study titled "An Open-Label Study of CTI-1601 in Subjects With Friedreich's Ataxia". An open label study designed to evaluate the safety, PK, PD, and clinical effects of long-term daily administration of CTI-1601 enrolling adolescent and adult patients with FRDA who have participated in a prior clinical study of CTI-1601 as well as children (age 2 years and older), adolescents and a...

What is the current status of trial NCT06447025?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2024-01-25. Estimated completion is 2027-01.

What interventions are being tested in trial NCT06447025?

The interventions under investigation include: CTI-1601 (DRUG).

Who is sponsoring clinical trial NCT06447025?

This trial is sponsored by Larimar Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06447025's enrollment target sits among peer trials

85 820th of 2000 higher than 1,179 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06447025, the US trial registry maintained by the National Library of Medicine. NCT06447025 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.