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

AOU MATERDOMINI0 sites164 target enrollmentDecember 30, 2021

Overview

No summary available.

Registry

who.int

Start Date

December 30, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

AOU MATERDOMINI

•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

•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.