Phase 3 Peripheral Neuropathy Trial, Recruiting NCT03198702 Sponsor: University Hospital, Brest Condition: Peripheral Neuropathy
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Phase 3 Peripheral Neuropathy Trial, Recruiting

NCT03198702
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:

  • Babies (boys or girls) who have a birth-related injury affecting the nerves in one arm or shoulder (on one side only)
  • Babies who are between 10 and 11 months old
  • Babies who show at least one of two specific warning signs that the shoulder joint may be at risk of slipping out of position: either the affected shoulder cannot rotate outward as far as the unaffected shoulder (by at least 10 degrees), or the baby scores below a certain level on a movement assessment that looks at how well they can rotate the shoulder outward, lift the arm, bend the elbow, or turn the forearm
  • A parent or legal guardian who is 18 years or older has signed the consent form agreeing to their child's participation

Who may not be able to join:

  • Babies whose nerve injury affects both arms or shoulders
  • Babies for whom specialised nerve or muscle surgery is already planned between 12 and 18 months of age
  • Babies for whom botulinum toxin (a medication used in the trial) would not be considered safe to use
  • Babies for whom an MRI scan would not be safe
  • Babies for whom an MRI scan cannot be carried out in a paediatric day hospital setting, either due to safety concerns related to the sedation (light anaesthetic) required or due to practical limitations at the site
  • Babies whose parents or guardians are not in a position to give consent for their child to participate
  • Babies whose parents or guardians are under 18 years of age

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 7 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: (+33) 02 98 22.33.73

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
University Hospital, Brest
Registry
ClinicalTrials.gov
Start date
17 May 2018
Est. completion
1 June 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI).

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: 7 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