Phase 3 Peripheral Neuropathy Trial, Recruiting NCT06201611 Sponsor: St. John's Research Institute Condition: Peripheral Neuropathy
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Phase 3 Peripheral Neuropathy Trial, Recruiting

NCT06201611
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 aged 18 or older who have been diagnosed with diabetes (any type) for 5 years or less
  • People whose blood sugar control has been stable for the past three months, with a blood sugar marker (called HbA1c) below 9 at the time of joining
  • People who have signs of nerve damage (called neuropathy) confirmed by two specific tests: a nerve conduction study showing abnormal results in two or more nerves, plus at least one symptom or sign of nerve damage shown by a standard symptom questionnaire or physical examination score

Who may not be able to join:

  • People who have certain heart rhythm or electrical problems, such as a very slow resting heart rate (under 50 beats per minute), a condition called sick sinus syndrome, or specific types of heart conduction blocks
  • People with severe asthma, severe chronic lung disease (COPD), or acute heart failure
  • People whose doctor has determined they need a specific type of blood pressure medication called a non-dihydropyridine calcium channel blocker
  • People whose treating doctor determines they specifically need a different medication from the same drug family as the study drug (called beta-blockers)
  • People who have already had a major amputation of one or both lower limbs, or who are scheduled to have one

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 16 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
St. John's Research Institute
Registry
ClinicalTrials.gov
Start date
15 November 2024
Est. completion
30 December 2025

Where this trial is recruiting

🇮🇳 India

Primary endpoints

The mean nerve action potential amplitude (sural and tibial nerves) between Arm 1 and Arm 3 at 24 weeks follow-up.

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: 16 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