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NCT01313117 · ClinicalTrials.gov registry record · Phase 1
Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01313117: Completed Phase 1 study, sponsored by Northwestern University.
NCT01313117 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313117, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to find the best dose of ALA in patients that receive chemotherapy.
Primary Outcome
Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.
Interventions
- DRUG Alpha lipoic acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01313117 record still lists
NCT01313117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Alpha lipoic acid is the first listed.
NCT01313117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313117 about?
NCT01313117 is a clinical study titled "Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Neuropathy". This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study i...
What is the current status of trial NCT01313117?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2012-02. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01313117?
The interventions under investigation include: Alpha lipoic acid (DRUG).
Who is sponsoring clinical trial NCT01313117?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01313117's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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