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NCT01737398 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy
A Phase 2 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 173
- Enrollment target
NCT01737398: Completed Phase 2 study, sponsored by Ionis Pharmaceuticals.
NCT01737398 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 173 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01737398, a Phase 2 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 173 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).
Primary Outcome
The mNIS+7 composite score is a measure of neurologic impairment that evaluates muscle weakness, sensation, reflexes, nerve conduction, and autonomic function. The mNIS+7 Composite Score has a range of -22.32 to 346.32 and a higher mNIS+7 composite score indicates lower function.
Interventions
- DRUG Placebo
- DRUG Inotersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2013-03-15 |
| Est. Completion | 2017-11-07 |
| Phase | Phase 2 |
What the finished NCT01737398 record still lists
NCT01737398 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01737398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01737398 about?
NCT01737398 is a clinical study titled "Efficacy and Safety of Inotersen in Familial Amyloid Polyneuropathy". The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).
What is the current status of trial NCT01737398?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 173 participants. The study started on 2013-03-15. Estimated completion is 2017-11-07.
What interventions are being tested in trial NCT01737398?
The interventions under investigation include: Placebo (DRUG), Inotersen (DRUG).
Who is sponsoring clinical trial NCT01737398?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01737398's enrollment target sits among peer trials
173 397th of 2000 higher than 1,604 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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