BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to assess the safety and efficacy of repeated administrations of BoNT-A in subjects with NP attributable to carpal tunnel syndrome (CTS) through a randomized, double-blind, placebo-controlled study. Further research has shown that BoNT-A has analgesic properties independently from its action on muscle tone, possibly by acting on neurogenic inflammation. Therefore, the study drug may be better than other treatments surgical or non-surgical currently available for the treatment of CTS.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Francesco Bono
• Treatments: incobotulinumtoxinA

Criteria

Inclusion Criteria:

1. Male or female subject aged ≥18 and ≤60 years old.

2. Probable or definitive NP according to the International Association for the Study of Pain criteria.

3. Daily pain attributable to CTS for at least 6 months. This must be attributable to idiopathic carpal tunnel syndrome and with nerve conduction velocity findings consistent with this condition

4. Moderate-severe pain according to the 11-point Numerical. Rating Scale (NRS; 4-8)

5. We allow the concomitant use of analgesic treatments if they have been used at a stable doses for 4 weeks before the enrolment and for the whole study.

6. Signed informed consent prior to participation in the study

Exclusion Criteria:

1. Pain level ≥9 on 11-point NRS.

2. CTS with atrophy of median-innervated muscles and EMG study suggesting a severe nerve injury.

3. Subject with contraindications or hypersensitivity to BoNT-A.

4. Subject with disorders of the neuromuscular junction, progressive neuropathy disorders, coagulation disorders or major psychiatric disorders.

5. Subject with diabetes, rheumatoid arthritis, connective tissue diseases, vasculitis, untreated hypothyroidism, acromegaly.

6. Subject using drugs acting on neuromuscular junctions, topical drugs (e.g., capsaicin or lidocaine), or anesthetic blocks.

7. Subject has used BoNT-A.

8. Subject is pregnant or breastfeeding women.

9. Subject enrolled in another interventional trial for the treatment of of the same disease.