BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome (NCT05411900) | Clinical Trial Compass
UnknownPhase 2
BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome
Italy164 participantsStarted 2022-05-25
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Efficacy of two successive administrations of several injections of BoNT-A, compared with placebo by NRS
Timeframe: 25 weeks
2
Efficacy of two successive administrations of several injections of BoNT-A, compared with placebo by NRS