E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007697 |
E.1.2 | Term | Carpal tunnel syndrome |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluation of the effect induced by Nicetile ® on sensory nerve conduction velocity (VCNS) of the median nerve in patients with carpal tunnel syndrome.
|
|
E.2.2 | Secondary objectives of the trial |
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 ®.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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 ®. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |