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NCT02415127 · ClinicalTrials.gov registry record · Phase 3
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 92
- Enrollment target
NCT02415127: Completed Phase 3 study, sponsored by Amgen.
NCT02415127 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 92 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02415127, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 92 participants
- Enrollment target
Study Summary
The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients.
Primary Outcome
The FARS assessment includes neurological signs that specifically reflect neural substrates affected in FA. Based on a neurological examination, bulbar, upper limb, lower limb, peripheral nerve, and upright stability/gait functions were assessed. The FARS-mNeuro score excludes the peripheral nervous system subscale score and the facial and tongue atrophy and fasciculations from the bulbar subscale score. Scores range from 0 (normal) to 93 (most impairment). A negative change from baseline is an
Interventions
- DRUG Placebo
- DRUG Interferon γ-1b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-11 |
| Phase | Phase 3 |
What the finished NCT02415127 record still lists
NCT02415127 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02415127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02415127 about?
NCT02415127 is a clinical study titled "Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia". The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients.
What is the current status of trial NCT02415127?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 92 participants. The study started on 2015-06. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02415127?
The interventions under investigation include: Placebo (DRUG), Interferon γ-1b (DRUG).
Who is sponsoring clinical trial NCT02415127?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02415127's enrollment target sits among peer trials
92 1723rd of 2000 higher than 277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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