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

Sensory Motor Neuropathies of the sciatic nerve: a comparative evaluation of dextrorotatory enantiomer of thioctic acid and acetyl-L-carnitine. - NESMOSCITICA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006235-33-IT

Enrollment

100

Registered

2012-04-02

Start date

2012-03-30

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sensitive motor sciatic neuropathy MedDRA version: 14.1 Level: PT Classification code 10066699 Term: Acute polyneuropathy System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: NICETILE*30CPR 500MG Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: LEVOCARNITINE HYDROCHLORIDE Current Sponsor code: NA Other descriptive name: NA Concentration unit: m

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactDirezione Medica

MDM S.p.A.

r.gabriele@mdmspa.com0393909114

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026