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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 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 92 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02415127
The ClinicalTrials.gov registry entry for NCT02415127 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02415127 reports 0 study locations.
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.
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