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NCT01928849 · ClinicalTrials.gov registry record · Phase 2
Valproic Acid for the Prevention of Post-Amputation Pain
A Phase 2 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT01928849: Completed Phase 2 study, sponsored by Duke University.
NCT01928849 is a Phase 2 study that has completed, run by Duke University. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928849, a Phase 2 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the prevention of chronic neuropathic and post-amputation pain, as well as to further define the underlying inflammatory and epigenetic mechanisms that lead to the development of such chronic pain. HYPOTHESES AND QUESTIONS Hypothesis 1: The use of oral valproic acid in combination with regional anesthesia in surgical limb-injury patients will decrease the incidence of chronic nerve injury and post-amputation pain. Goal 1: In a blinded, randomized placebo-controlled, multi-center clinical trial, investigators will determine if oral VPA added to regional anesthesia and standard perioperative management will reduce the incidence of nerve injury and post-amputation pain when compared with regional anesthesia alone. Hypothesis 2: The transition from acute to chronic pain is mediated via epigenetic mechanisms (differential DNA methylation) in genes involved in nociception. Goal 2: Investigators will analyze the DNA methylation patterns of patients with different types of neuropathic and post-amputation pain and determine if they are altered by VPA.
Primary Outcome
The primary endpoint is the incidence of chronic pain after surgery. The study team will use the average pain score over the past week as noted on the Self-Reported Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS) for the assessment of pain, and define chronic pain as a score greater than or equal to 3.
Interventions
- DRUG Valproic Acid
- OTHER Cherry Syrup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2013-12 |
| Est. Completion | 2017-09-26 |
| Phase | Phase 2 |
What the finished NCT01928849 record still lists
NCT01928849 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Valproic Acid is the first listed.
NCT01928849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928849 about?
NCT01928849 is a clinical study titled "Valproic Acid for the Prevention of Post-Amputation Pain". The objectives of this study are, to test the effectiveness of Valproic Acid (VPA) in the prevention of chronic neuropathic and post-amputation pain, as well as to further define the underlying inflammatory and epigenetic mechanisms that lead to the development of such chronic pain. HYPOTHESES AND ...
What is the current status of trial NCT01928849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2013-12. Estimated completion is 2017-09-26.
What interventions are being tested in trial NCT01928849?
The interventions under investigation include: Valproic Acid (DRUG), Cherry Syrup (OTHER).
Who is sponsoring clinical trial NCT01928849?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01928849's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 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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