Comparison of two products (dextrorotatory enantiomer of thioctic acid - food supplement - and acetyl-l-carnitine - drug) in the treatment of sciatic nerve disease

Conditions: sensitive motor sciatic neuropathy
MedDRA version: 14.1Level: PTClassification code 10066699Term: Acute polyneuropathySystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-006235-33-IT

Lead Sponsor: MDM S.P.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients will need: • be suffering from radiculopathy of the lower limbs, • is diagnosed with certainty with CT or MRI, • presenting with unilateral or bilateral, • the first event, • with a date of onset not exceeding 40 days
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Patients must not: • be suffering from severe cognitive deficits or psychiatric disorders, • have a specific indication for surgery, • with poor compliance towards inclusion in the study, • be carriers of cancer, • be under chemotherapy (immunosuppression), • be treated with thioridazine hydrochloride.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Clinical trial comparing the efficacy of two products for oral administration: - Dextrorotatory enantiomer of thioctic acid (food supplement) - Acetyl-L-carnitine (drug) compared to evaluate their effectiveness in containing and countering the symptoms and functional outcomes that are generated in the sensory motor neuropathy of the sciatic nerve.;Secondary Objective: - Improved quality of sleep after treatment with both active. - Control of pain during the entire treatment period.;Primary end point(s): - Comparative assessment of the trend of specific symptoms, functionality of the sciatic nerve and the safety of the two active treatments;Timepoint(s) of evaluation of this end point: 60 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - variation of the consumption of analgesics taken during the whole treatment period; - Subjective assessment of sleep quality (increased, unchanged, decreased) in the treatment of patients.;Timepoint(s) of evaluation of this end point: 60 days