Reflex Sympathetic Dystrophy RDS and Complex Regional Pain Syndrome CRPS . MedDRA version: 9.1 Level: LLT Classification code 10007825 Term: Causalgia
Conditions
Interventions
Trade Name: ZIBREN*IM IV 5FL LIOF+5F 4ML
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Acetylcarnitine
Concentration unit: mg milligram(s)
Concentration type
Sponsors
SIGMA-TAU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients of both sexs of age between 18 and 60 years old. 2. Diagnosys of RSD/CRPS of post-traumatic origin. 3.Written Informative 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The patients will not be enrolled in the study if they match any of these criteria 1. the presence of any cronic patology; 2. pregnancy or breast feeding; 3. known or suspected hypersensibility to Acetyl-l-carnitine or its derivative; 4. Treatment with Acetyl-l-carnitine or its derivative in the six months previous the beginning of the study; 5. patology with algia; 6. partecipation in other clinical trials in the 3 months previous to the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the efficacy of ALC, administered transdermally through the gel fisio of the Hydrofor system Bioelectra S.r.l. Via Pantano 2 - 20122 Milan ,on the progress of pain in patients suffering from RSD/ CRPS of post-traumatic origin.;Secondary Objective: To evaluate the vascular,nervous and tissue characteristic of the affected zone and the impact of pain on the life quality of the patient.To evaluate vascular functionality with the Eco power doppler to analyze the amyelinic innervation of the epidermis and the myelinic innervation of the dermis through cutaneous biopsy and to evaluate the volume of the bone edema of the affected zone by magnetic resonance RM .And also to evaluate the variation in life quality with Flanagan scale.;Primary end point(s): To evaluate the efficacy of ALC, administered transdermally through the gel fisio of the Hydrofor system Bioelectra ,on the progress of pain in patients suffering from RSD/ CRPS of post-traumatic origin, with the Visual Analogue Scale of Scott Huskisson VAS and Fisher s algometer. | — |
Countries
Italy
Outcome results
None listed