Phase 3 Stroke Trial, Recruiting NCT06446960 Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Condition: Stroke
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Phase 3 Stroke Trial, Recruiting

NCT06446960
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:

  • You are 18 years old or older (there is no upper age limit)
  • You have pain in an arm or leg that is focused enough to be fully covered by a nerve-blocking injection
  • You have had this pain for at least 6 months
  • You have had a stroke (either a bleed or a blockage in the brain) at least 6 months ago, confirmed by a brain scan (MRI)
  • Your pain developed after your stroke and has been identified as nerve pain, based on a specific assessment tool called the DN4 (with a score of at least 4 out of 10)
  • Your pain level is 4 or higher out of 10 on a pain scale at the time of joining and before each treatment session
  • You are covered by a social security or health insurance scheme (this appears to be a French healthcare requirement — confirm with trial site)
  • You have been on a stable painkiller routine for at least 2 weeks before joining
  • You are willing and able to give your signed agreement to take part

Who may not be able to join:

  • You are unable or unwilling to give your signed consent to take part
  • You are under a legal protection order, such as guardianship or curatorship (confirm with trial site)
  • You have an ongoing serious mental health condition (such as major depression or psychosis) or memory/thinking difficulties that would make it hard to follow the study or complete questionnaires
  • Your pain is too widespread across a limb or side of the body to be fully covered by a nerve-blocking injection
  • You are currently misusing drugs or other substances
  • You have difficulty with language or understanding (for example, due to stroke-related speech problems), or you are unable to read
  • You have moderate to severe kidney or liver problems
  • You have a reason why local anaesthetic injections near a nerve would not be safe for you, such as an infection or inflammation at the injection site, or a known allergy to local anaesthetics
  • You are pregnant or breastfeeding
  • You have a known allergy to lidocaine, levobupivacaine, or similar local anaesthetic medicines
  • You have a condition called recurrent porphyria, or you have severely low blood pressure that makes it unsafe to use the study medicines
  • You are currently taking certain heart rhythm medications that cannot be stopped, which may interact with the study treatment (confirm specific medications with trial site)
  • Your pain level drops below 4 out of 10 at the time of the nerve block sessions
  • Your painkiller treatment needs to be changed at the start of or during the study

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 22 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

Phone: 01 47 10 76 22

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
Institut National de la Santé Et de la Recherche Médicale, France
Registry
ClinicalTrials.gov
Start date
9 February 2024
Est. completion
8 September 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

To evaluate the efficacy of two peripheral nerve blocks performed 14 days apart on spontaneous neuropathic pain after stroke. The active treatments used for the blocks will be either lidocaine 20mg/ml or levobupivacaine 1.25mg/ml or placebo (saline)

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: 22 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