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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04678895
The ClinicalTrials.gov registry entry for NCT04678895 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 5 other Painful Diabetic Neuropathy trials with a reported enrollment target (72% lower). The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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