Phase 3 Peripheral Neuropathy Trial, Recruiting NCT06616025 Sponsor: Neuraptive Therapeutics Inc. Condition: Peripheral Neuropathy
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Phase 3 Peripheral Neuropathy Trial, Recruiting

NCT06616025
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have voluntarily agreed to take part and have signed an approved consent form.
  • People aged between 18 and 80 years old.
  • People who have a severe nerve cut (classified as Sunderland's 4th or 5th degree) in the arm or hand that has caused loss of nerve function and requires surgery to treat.

Who may not be able to join:

  • People whose nerve repair surgery would happen more than 48 hours after the nerve was cut.
  • People whose nerve repair would require using a piece of nerve taken from elsewhere in the body, a donor nerve, or a tube-like device to bridge the nerve gap.
  • People with more than one cut nerve, unless all of the injured nerves can be repaired by directly rejoining the nerve ends (confirm with trial site).
  • People who, in the opinion of the trial doctor, are unlikely to show meaningful recovery within a reasonable timeframe due to significant muscle wasting or other serious health conditions.
  • People whose injury was the result of a suicide attempt or self-harm.
  • People who have a documented history or signs of conditions where the study treatment might not be beneficial, such as diseases affecting the muscles or nervous system throughout the body, or who are on treatments known to affect nerve or blood vessel growth.
  • People with a known allergy to polyethylene glycol (PEG) or medical-grade silicone.
  • People who are pregnant or breastfeeding.
  • People who are currently enrolled in another clinical trial, or who have taken part in one within the past 30 days before screening.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Seth Schulman, MD, Neuraptive Therapeutics Inc.

Phone: 215-206-9504

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Neuraptive Therapeutics Inc.
Registry
ClinicalTrials.gov
Start date
10 February 2025
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean Michigan Hand Questionnaire (MHQ) Two Domain Score (ADL and Pain); Safety - Columbia-Suicide Severity Rating Scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov