Evaluation of patients with carpal tunnel syndrome treated with Nicetile ®.

Electroneurographic and clinical evaluation in patients with mild / moderate Carpal Tunnel Syndrome , following conservative pharmacological treatment with Nicetile®. - Evaluation of patients with carpal tunnel syndrome treated with Nicetile ®.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002289-62-IT

Enrollment

Unknown

Registered

2014-07-03

Start date

2014-09-11

Completion date

Unknown

Last updated

2017-04-03

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

Conditions

Carpal Tunnel Syndrome MedDRA version: 17.0 Level: PT Classification code 10007697 Term: Carpal tunnel syndrome System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Nicetile® Product Name: Nicetile® Product Code: ST200 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: L- ACETYLCARNITINE Current Sponsor code: ST2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients of both sexes aged = 18 and = 65 years. 2. Patients with sensory disturbances (BCTQ and Hi-Ob) compatible with carpal tunnel syndrome of not more than 12 months occurrence and CTS electroneurographic diagnosis mild / moderate (according to Padua L. et al., 1998). 3. Willingness to follow the procedures of the Protocol for at least 120 days. 4. Obtaining of a written informed 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: 1. Patient history of surgery for CTS. 2. Previous infiltrative local therapy with corticosteroids. 3. Acute trauma to the median nerve. 4. Previous traumatic fractures of the wrist with joint deformity. 5. Clinic objectivity compatible with polyneuropathy or cervical radiculopathy. 6. Rheumatic and autoimmune disorders. 7. Hypothyroidism or other endocrine disorders, diabetes, BMI = 30; amyloidosis; gout. 8. Psychiatric disorders. 9. Chronic or active known infectious diseases, that in the opinion of the investigator may involve the CNS and / or PNS. 10. Neoplastic disorders in the 5 years prior to enrollment. 11. Intake of the following drugs in the period prior to screening: 1 week to NSAIDs; 2 weeks for anticonvulsants, steroids, and cannabis derivatives; 2 months for antidepressants); 3 months for L-carnitine or its derivatives and oral hypoglycemic agents. 12. Drugs or alcohol use. 13. Known kidney failure (serum creatinine> 2X the upper limit of the reference laboratory of the center). 14. Known Hepatic impairment (AST and / or ALT> 3X the upper limit of the reference laboratory of the center). 15. Participation in other clinical trials within the previous 3 months. 16. Pregnant or breast-feeding women.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of the effect induced by Nicetile ® on sensory nerve conduction velocity (VCNS) of the median nerve in patients with carpal tunnel syndrome. ;Secondary Objective: The evaluation of the effect induced by Nicetile ® in patients with carpal tunnel syndrome: • on different electroneurographic parameters and neurophysiological grading; • on the clinical picture, on the pain and on the correlation between neuropathic pain and the electroneurographic parameters; • the safety profile and tolerability of treatment with Nicetile ®. ;Primary end point(s): Improvement in sensory nerve conduction velocity (VCNS) of the median nerve during (T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®.;Timepoint(s) of evaluation of this end point: T60 and T120	—

Measure

Time frame

Main Objective: Evaluation of the effect induced by Nicetile ® on sensory nerve conduction velocity (VCNS) of the median nerve in patients with carpal tunnel syndrome. ;Secondary Objective: The evaluation of the effect induced by Nicetile ® in patients with carpal tunnel syndrome: • on different electroneurographic parameters and neurophysiological grading; • on the clinical picture, on the pain and on the correlation between neuropathic pain and the electroneurographic parameters; • the safety profile and tolerability of treatment with Nicetile ®. ;Primary end point(s): Improvement in sensory nerve conduction velocity (VCNS) of the median nerve during (T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®.;Timepoint(s) of evaluation of this end point: T60 and T120

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Secondary

Measure	Time frame
Secondary end point(s): • Improvement of the amplitude of the sensory potential (ASP), distal motor latency (DML), the amplitude of the motor potential (MAP) of the median nerve during (T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®. • Improvement (compared to T0) of neurophysiological grading at the completion (T120) of conservative pharmacological treatment with Nicetile ®. • Improvement of the clinical picture through self-assessment test (BCTQ Boston Carpal Tunnel Questionnaire, considering separately the scores for symptoms (BCTQ / S, 11 items) and function (BCTQ / F, 8 items), and objective tests (Hi Ob-Clinical Historical-objective) during (T10 and T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®. • Improvement of pain symptoms in patients with DN4 score = 4, assessed with the scale I-NPSI, during (T10 and T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®. • Identifying the relationship between neuropathic pain (measured and evaluated using I-NPSI) and the electroneurographic parameters. • Monitoring the safety profile and the tolerability of treatment with Nicetile ®, in terms of frequency and severity of adverse reactions. ;Timepoint(s) of evaluation of this end point: T10, T60, T120	—

Measure

Time frame

Secondary end point(s): • Improvement of the amplitude of the sensory potential (ASP), distal motor latency (DML), the amplitude of the motor potential (MAP) of the median nerve during (T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®. • Improvement (compared to T0) of neurophysiological grading at the completion (T120) of conservative pharmacological treatment with Nicetile ®. • Improvement of the clinical picture through self-assessment test (BCTQ Boston Carpal Tunnel Questionnaire, considering separately the scores for symptoms (BCTQ / S, 11 items) and function (BCTQ / F, 8 items), and objective tests (Hi Ob-Clinical Historical-objective) during (T10 and T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®. • Improvement of pain symptoms in patients with DN4 score = 4, assessed with the scale I-NPSI, during (T10 and T60) and at completion (T120) of conservative pharmacological treatment with Nicetile ®. • Identifying the relationship between neuropathic pain (measured and evaluated using I-NPSI) and the electroneurographic parameters. • Monitoring the safety profile and the tolerability of treatment with Nicetile ®, in terms of frequency and severity of adverse reactions. ;Timepoint(s) of evaluation of this end point: T10, T60, T120

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Countries

Italy

Contacts

Public ContactServ. Scientifico e Medical Affairs

SIGMA-TAU, Industrie Farmaceutiche Riunite S.p.A.

leonardo.scalia@sigma-tau.it00390691393525

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 25, 2026