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NCT04678895 · ClinicalTrials.gov registry record · Phase 2
Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy
A Phase 2 study of Painful Diabetic Neuropathy, sponsored by Dartmouth-Hitchcock Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT04678895: Recruiting Phase 2 study of Painful Diabetic Neuropathy, sponsored by Dartmouth-Hitchcock Medical Center.
NCT04678895 is a Phase 2 study of Painful Diabetic Neuropathy that is actively recruiting participants, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 35 participants, below the 125-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04678895, a Phase 2 study of Painful Diabetic Neuropathy, is actively recruiting participants, sponsored by Dartmouth-Hitchcock Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Diabetes affects more than 30 million people in the United States and is a leading cause of morbidity. Over 25% diabetics also suffer from debilitating painful diabetic neuropathy in the lower legs and feet. This pain can be severe, difficult to control, and have a significant negative impact on quality of life. Opioid medications have historically been a mainstay of treatment for this pain, despite the risks. As the death toll from the U.S. opioid epidemic continues to rise, the need for quality alternative non-opioid medications to treat pain becomes more urgent. One of these potential medications is Low-Dose Naltrexone (LDN). This drug is reported to work by enhancing the body's natural pain relieving mechanisms and decreases inflammation by targeting specific cells called microglia which have been shown to influence chronic pain. LDN has been shown to be a safe medication with minimal side effects. Its efficacy has been demonstrated in other painful conditions but has never been fully studied for treating painful diabetic neuropathy. The goal of this randomized, placebo-controlled trial is to determine if LDN is effective for treating the pain caused by diabetic neuropathy. LDN's mechanism of action is well suited to treating painful diabetic neuropathy, and LDN shows significant promise as a safe, non-opioid alternative that can decrease pain and improve quality of life for those suffering from this painful condition.
Primary Outcome
Pain Disability index (PDI) Score measures the degree to which pain interferes with activities. Every item ranges from 0 (no interference) to 10 (total interference). The total PDI score can range from 0 to 70, a higher score indicating more interference with functioning across a range of activities.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naltrexone
Study Locations (1)
New Hampshire
- Dartmouth-Hitchcock Medical Center - Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-12-22 |
| Est. Completion | 2025-09 |
| Phase | Phase 2 |
What NCT04678895 shows while recruiting
NCT04678895 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 125-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Painful Diabetic Neuropathy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04678895 reports a single indexed study location in New Hampshire.
Frequently Asked Questions
What is clinical trial NCT04678895 about?
NCT04678895 is a clinical study titled "Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy". Diabetes affects more than 30 million people in the United States and is a leading cause of morbidity. Over 25% diabetics also suffer from debilitating painful diabetic neuropathy in the lower legs and feet. This pain can be severe, difficult to control, and have a significant negative impact on qua...
What is the current status of trial NCT04678895?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2020-12-22. Estimated completion is 2025-09.
What conditions does trial NCT04678895 study?
This clinical trial studies the following conditions: Painful Diabetic Neuropathy.
What interventions are being tested in trial NCT04678895?
The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04678895?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04678895 being conducted?
This trial has 1 study location across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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