Plain-English translation of NCT04678895 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing at very low doses to treat painful nerve damage caused by diabetes. The study will compare the medication to a placebo (a fake pill) to see if this treatment can reduce pain. You would take one capsule by mouth each day, with the dose slowly increasing over the first two weeks and then staying steady.
Diabetic nerve pain is difficult to treat, and many people don't get relief from standard medications like gabapentin or duloxetine. Researchers are exploring whether this medication at much lower doses than what's currently approved might help people whose pain hasn't improved with other treatments.
You likely qualify if…
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You would join one of two groups. One group takes the medication for 8 weeks first, then placebo for 4 weeks; the other group takes placebo for 4 weeks first, then the medication for 8 weeks. You'll take one capsule by mouth daily throughout the study. The medication dose starts low and gradually increases over the first two weeks. Neither you nor the researchers will know which treatment you're getting at any given time. You can continue taking your other non-opioid pain medications as usual during the study.
AI-generated summary from trial data · Jun 25, 2026 · Not medical advice
United States