Carpal Tunnel Syndrome (CTS) MedDRA version: 17.0 Level: LLT Classification code 10052414 Term: Unilateral carpal tunnel syndrome System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Núcleo CMP Forte ®
Product Name: Núcleo CMP Forte
Pharmaceutical Form: Capsule
INN or Proposed INN: URIDINE MONOPHOSPHATE
CAS Number: 58-97-9
Other descriptive name: URIDINE MONOPHOSPHATE
Sponsors
Dr. Jordi Montero Homs- Unidad de Neuromuscular- Servicio de Neurología- Hospital Universitario de Bellvitge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients between 18 and 80 years old. 2) Patients clinically and electrophysiological diagnosed with CTS, who won?t require a premature surgical procedure. 3) Patients able to understand the study objective and able to give the Inform Consent. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Pregnant or breastfeeding woman. 2) Patients with high probablility os not completing the study requirements according to the investigator criteria. 3) Patients with dysphagia which won?t allow them to take the study medication. 4) Patients diagnosed with neuropathy which is causing an axonal degeneration. 5) Patients with a recent forearm trauma. 6) Patients participating in antother Clinical Trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the treatment of symptoms with Nucleo CMP Forte in patients diagnosed with CTS, using pain escales and quantification of sensitive positive symptoms;Secondary Objective: 1) To evaluate the improvement of life quality measured by SF36 test. 2) To evaluate the improvement of electrophysiologic parametes according to sensitive conduction in carpal tunnel, distal motor latency, as well as motor and sensory potential amplitude. 3) To evaluate the safety of the treatment with CMP Forte in patients with pain due to CTS.;Primary end point(s): Pain intensity acoording visual analogical escale at 6 months of treatment and 30 days after finishing the last dose of study treatment. Positive sensitive symptomatolgy manifested as paresthesia and dysesthesia at 6 months of treatment according to the evaluation of Carpal Tunnel?s sign and Phalen?s sign.;Timepoint(s) of evaluation of this end point: Baseline, 6 months of treatment and 30 days after completion of study treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Life quality at 6 months of treatment according to SF36 questionaire - Adverse events - Elecrophysiologic parameters: sensitive and motor medium nerve conduction. Segments stimulation. Evaluation of: -Amplitude; response produced by the stimulation of two points along the nerve. This response will depend on the number of nervous functional muscle fibers and the integrity of neuromuscular unions. - Latency: period of time of recording the estimulus - Nervous conduction velocity; stimulus transmission velocity on a specific nerve;Timepoint(s) of evaluation of this end point: Especificados para cada objetivo secundario en la sección E.5.2. | — |
Countries
Spain
Contacts
Public ContactDr. Jordi Montero Homs
Hospital Universitari de Bellvitge
Outcome results
None listed