Status:
UNKNOWN
BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome
Lead Sponsor:
Francesco Bono
Conditions:
Carpal Tunnel Syndrome
Neurogenic Inflammation
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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-b...
Detailed Description
Botulinum toxin type A (BoNT-A) is widely used to treat muscle hyperactivity, based on its ability to inhibit synaptic exocytosis and, therefore, to disable neural transmission. Further research has s...
Eligibility Criteria
Inclusion
- Male or female subject aged ≥18 and ≤60 years old.
- Probable or definitive NP according to the International Association for the Study of Pain criteria.
- 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
- Moderate-severe pain according to the 11-point Numerical. Rating Scale (NRS; 4-8)
- 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.
- Signed informed consent prior to participation in the study
Exclusion
- Pain level ≥9 on 11-point NRS.
- CTS with atrophy of median-innervated muscles and EMG study suggesting a severe nerve injury.
- Subject with contraindications or hypersensitivity to BoNT-A.
- Subject with disorders of the neuromuscular junction, progressive neuropathy disorders, coagulation disorders or major psychiatric disorders.
- Subject with diabetes, rheumatoid arthritis, connective tissue diseases, vasculitis, untreated hypothyroidism, acromegaly.
- Subject using drugs acting on neuromuscular junctions, topical drugs (e.g., capsaicin or lidocaine), or anesthetic blocks.
- Subject has used BoNT-A.
- Subject is pregnant or breastfeeding women.
- Subject enrolled in another interventional trial for the treatment of of the same disease.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05411900
Start Date
May 25 2022
End Date
December 1 2023
Last Update
June 9 2022
Active Locations (1)
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1
Aou Mater Domini
Catanzaro, Italy, 88100