BotulInum toxin type A for peripheral Neuropathic pain in subjEcts with Carpal Tunnel syndrome: a multicenter, randomized, double-blind, placebo-controlled study

Phase 1

• Conditions: Peripheral neuropathic pain in subjects with carpal tunnel syndrome; MedDRA version: 20.0Level: LLTClassification code 10007698Term: Carpel tunnel syndromeSystem Organ Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code 10077974Term: Peripheral neuropathic painSystem Organ Class: 100000004852; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2021-006048-29-IT
• Lead Sponsor: AOU MATERDOMINI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-30
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

A participant will be eligible to enroll in the study only if all the following criteria are met: a) The participant is a male or female subject aged =18 and =60 years old; b) The participant meets the criteria for probable or definite NP according to the International Association for the Study of Pain [Treede 2008]; c) The participant has been having daily pain, attributable to CTS, for at least 6 months; d) The pain level is rated as moderate–severe (4–8 points) according to the 11-point NRS; e) The participant is able and willing to provide written informed consent; f) 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 164
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient will be ineligible for enrolment in this study if any of the following criteria are met: 1) The pain level is rated as =9 on the 11-point NRS; 2) The participant has CTS with atrophy of median-innervated muscles; 3) The participant presents contraindications or hypersensitivity to BoNT-A; 4) The participant suffers from disorders of the neuromuscular junction, coagulation disorders, or major psychiatric disorders; 5) The participant is using drugs acting on neuromuscular junctions, topical drugs (e.g., capsaicin or lidocaine), or anesthetic blocks; 6) The participant has diabetes, rheumatoid arthritis, connective tissue diseases, vasculitis, untreated hypothyroidism, acromegaly. 7) The participant has previously used BoNT-A; 8) The participant is pregnant or breastfeeding; 9) The participant is enrolled in another interventional trial for the treatment of the same disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified