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NCT05579691 · ClinicalTrials.gov registry record · Phase 2
A Double-Blind, Placebo-Controlled, Dose Exploration Study of CTI-1601 in Adult Subjects With Friedreich's Ataxia
A Phase 2 study of Friedreich Ataxia, sponsored by Larimar Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05579691: Completed Phase 2 study of Friedreich Ataxia, sponsored by Larimar Therapeutics.
NCT05579691 is a Phase 2 study of Friedreich Ataxia that has completed, run by Larimar Therapeutics. The registered enrollment target is 28 participants, below the 448-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05579691, a Phase 2 study of Friedreich Ataxia, has completed, sponsored by Larimar Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) administration of CTI-1601 over 28 days in subjects with Friedreich's ataxia (FRDA).
Primary Outcome
Overall summary of Participants with Treatment Emergent Adverse Events
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL CTI-1601
Study Locations (1)
New Jersey
- Clinilabs Drug Development Corporation - Eatontown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-09-21 |
| Est. Completion | 2023-12-04 |
| Phase | Phase 2 |
What the finished NCT05579691 record still lists
NCT05579691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 448-participant average among 14 other Friedreich Ataxia trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Friedreich Ataxia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05579691 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05579691 about?
NCT05579691 is a clinical study titled "A Double-Blind, Placebo-Controlled, Dose Exploration Study of CTI-1601 in Adult Subjects With Friedreich's Ataxia". To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneous (SC) administration of CTI-1601 over 28 days in subjects with Friedreich's ataxia (FRDA).
What is the current status of trial NCT05579691?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2022-09-21. Estimated completion is 2023-12-04.
What conditions does trial NCT05579691 study?
This clinical trial studies the following conditions: Friedreich Ataxia.
What interventions are being tested in trial NCT05579691?
The interventions under investigation include: Placebo (OTHER), CTI-1601 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05579691?
This trial is sponsored by Larimar Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05579691 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Friedreich Ataxia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05579691's enrollment target sits among peer trials
28 11th of 14 higher than 4 of 14 other Friedreich Ataxia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Friedreich Ataxia 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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