Peripheral neuropathic pain in subjects with carpal tunnel syndrome MedDRA version: 20.0 Level: LLT Classification code 10007698 Term: Carpel tunnel syndrome System Organ Class: 100000004852 MedDRA version: 20.0 Level: LLT Classification code 10077974 Term: Peripheral neuropathic pain System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Dysport
Product Name: Tossina botulinica tipo A da C. botulinum complesso - emoagglutinina
Product Code: [Dysport 500 unità]
Pharmaceutical Form: Powder and solvent for solution for inject
Sponsors
AOU MATERDOMINI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of two successive intradermal administrations of several injections of BoNT-A versus placebo, administered 12 weeks apart, in subjects with CTS and NP.;Secondary Objective: The secondary objectives of this study include: a) Assessment of the therapeutic gain of BoNT-A in terms of relief of spontaneous pain; b) Assessment of BoNT-A effects in reducing neuropathic symptoms; c) Assessment of BoNT-A impact on patient’s quality of life; d) Assessment of BoNT-A safety and tolerability.;Primary end point(s): The primary efficacy endpoint is the efficacy of two successive administrations of several injections of BoNT-A, compared with placebo, measured as: 1) Change in mean weekly self-reported average daily pain intensity (mean pain over the past 24 hours recorded every morning in patient’s diary during a week) measured by the 11-point numerical rating scale (NRS, 0=no pain, 10=maximum pain imaginable) of the brief pain inventory (BPI) from baseline (one week before randomisation) to 24 weeks after the first administration. 2) Change in weekly self-reported maximum daily pain intensity (maximum pain intensity over the past 24 hours recorded every morning in patient’s diary) measured by the 11-point NRS of the BPI from baseline (1 week before randomisation) to 24 weeks after the first administration. Patients with a reduction > 30% in pain intensity as compared to baseline are considered responders. That is, we expected a movement of 2 points on NRS scale to be of clinical significance;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Therapeutic gain of the second administration of BoNT-A, in terms of relief of spontaneous pain, measured as change in mean weekly average daily pain intensity measured by the 11-point NRS of the BPI from one week before 12 weeks and 24 weeks and change in maximum pain from 12 weeks and 24 weeks, in subjects who received two administrations. 2) Effects of BoNT-A on: a) severity of brush-induced allodynia measured on the Visual Analogue Scale (VAS) from baseline to 24 weeks; b) sensory disturbances and hyperalgesia in response to mechanical punctate and thermal stimuli measured by sensory assessment at the bed side from baseline to 24 weeks; c) Neuropathic symptoms (ie, burning pain, deep pain, paroxysmal pain, paraesthesia or dysaesthesia, and allodynia) measured with the Neuropathic Pain Symptom Inventory (NPSI) from baseline to 24 weeks.Impact of BoNT-A treatment on patient’s quality of life measured through the Visual Analogue Scale (VAS) of the EuroQoL EQ-5D-5L from 0 (imaginable health state) to 100 (worst imaginable health state) from baseline to 24 weeks. 3) Safety and tolerability of botulinum toxin treatment are assessed throughout the study period using neurologic examination and a systematic and planned methodology including serious adverse events (SAE), treatment- emergent AEs (TEAEs) and AEs leading to withdrawal.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Italy
Contacts
Public ContactClinical Department
Advice Pharma s.r.l.
Outcome results
None listed