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    Summary
    EudraCT Number:2011-006235-33
    Sponsor's Protocol Code Number:738/02/2011
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-04-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-006235-33
    A.3Full title of the trial
    Sensory Motor Neuropathies of the sciatic nerve: a comparative evaluation of dextrorotatory enantiomer of thioctic acid and acetyl-L-carnitine.
    NEUROPATIE SENSITIVO MOTORIE DEL NERVO SCIATICO: VALUTAZIONE COMPARATIVA DELL'AZIONE DELL'ENANTIOMERO DESTROGIRO DELL'ACIDO TIOCTICO E DELLA ACETIL-L-CARNITINA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two products (dextrorotatory enantiomer of thioctic acid - food supplement - and acetyl-l-carnitine - drug) in the treatment of sciatic nerve disease
    Confronto dell'azione di due prodotti (enantiomero destrogiro dell'acido tioctico - integratore alimentare - e acetil-l-carnitina - specialita' medicinale) nel trattamento delle sofferenze del nervo sciatico
    A.3.2Name or abbreviated title of the trial where available
    NESMOSCITICA
    NESMOSCITICA
    A.4.1Sponsor's protocol code number738/02/2011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMDM S.P.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMDM S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMDM S.p.A.
    B.5.2Functional name of contact pointDirezione Medica
    B.5.3 Address:
    B.5.3.1Street AddressVia Volturno, 29/b
    B.5.3.2Town/ cityMonza
    B.5.3.3Post code20900
    B.5.3.4CountryItaly
    B.5.4Telephone number0393909114
    B.5.5Fax number039322888
    B.5.6E-mailr.gabriele@mdmspa.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NICETILE*30CPR 500MG
    D.2.1.1.2Name of the Marketing Authorisation holderSIGMATAU IND.FARM.RIUNITE SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLEVOCARNITINE HYDROCHLORIDE
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB02906MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number580
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typespecialità medicinale
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTHIOCTIC ACID
    D.3.2Product code NA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHIOCTIC ACID
    D.3.9.1CAS number 62-46-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameALPHA-LIPOIC-ACID
    D.3.9.4EV Substance CodeSUB15537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeINTEGRATORE ALIMENTARE
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    sensitive motor sciatic neuropathy
    neuropatie sensitivo motorie del nervo sciatico
    E.1.1.1Medical condition in easily understood language
    sciatic nerve disease
    sofferenza del nervo sciatico
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10066699
    E.1.2Term Acute polyneuropathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    Studio clinico di comparazione dell’efficacia di due prodotti per somministrazione orale: - enantiomero destrogiro dell’acido tioctico (integratore alimentare) - acetil-L-carnitina (specialità medicinale) messi a confronto per valutarne l’efficacia nel contenere e contrastare i sintomi e le conseguenze funzionali che vengono a generarsi nelle neuropatie sensitivo motorie del nervo sciatico.
    E.2.2Secondary objectives of the trial
    - Improved quality of sleep after treatment with both active. - Control of pain during the entire treatment period.
    - Miglioramento della qualità del sonno a seguito del trattamento con i due attivi. - Controllo della sintomatologia dolorosa durante tutto il periodo di trattamento.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    I pazienti dovranno: • essere affetti da radicolopatia degli arti inferiori, • già diagnosticata con certezza con TAC o RMN, • con presentazione monolaterale o bilaterale, • alla prima manifestazione, • con una data di esordio non superiore ai 40 giorni
    E.4Principal 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.
    I pazienti non dovranno: • essere affetti da deficit cognitivi severi o disturbi di natura psichiatrica, • avere una specifica indicazione chirurgica, • con scarsa compliance nei confronti dell’inclusione nello studio, • essere portatori di patologie tumorali, • essere sotto trattamento chemioterapico (immunodepressi), • essere in trattamento con tioridazina cloridrato.
    E.5 End points
    E.5.1Primary end point(s)
    - Comparative assessment of the trend of specific symptoms, functionality of the sciatic nerve and the safety of the two active treatments
    - valutazione comparativa dell'andamento della sintomatologia specifica, della funzionalità del nervo sciatico e della sicurezza di impiego dei due trattamenti attivi
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 days
    60 giorni
    E.5.2Secondary 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.
    variazione del consumo di analgesici assunti durante tutto il periodo di trattamento; - valutazione soggettiva della qualità del sonno (aumentata, invariata, diminuita) dei pazienti in trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 days
    60 giorni
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    ND
    ND
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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