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    EudraCT Number:2018-000282-37
    Sponsor's Protocol Code Number:AIFA-2016-02365063
    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:2021-06-17
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-000282-37
    A.3Full title of the trial
    Riluzole (Glentek) in patients with SpinoCerebellar Ataxia type 7: a randomized, double-blind, placebo-controlled pilot trial with a lead in phase
    Studio pilota randomizzato, doppio cieco, controllato secondo placebo con una fase iniziale di osservazione sull' utilizzo del riluzolo (Glentek) in pazienti affetti da Atassia Spinocerebellare di tipo 7
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Riluzole in spinocerebellar ataxia type 7
    Riluzolo in pazienti affetti da Atassia Spinocerebellare di tipo 7
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberAIFA-2016-02365063
    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.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAIFA - Italian Medicines Agency
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità La Sapienza
    B.5.2Functional name of contact pointDipartimento NESMOS
    B.5.3 Address:
    B.5.3.1Street AddressVia di Grottarossa, 1037
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.4Telephone number0633776044
    B.5.5Fax number0633775076
    D. IMP Identification
    D.IMP: 1
    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 Yes
    D. name Glentek 50 mg film-coated tablets
    D. of the Marketing Authorisation holderGlenmark Pharmaceuticals Europe Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGlentek 50 mg compresse rivestite con film
    D.3.2Product code [Glentek 50 mg compresse rivestite con film]
    D.3.4Pharmaceutical form Coated 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 INNRiluzolo
    D.3.9.1CAS number 1744-22-5
    D.3.9.2Current sponsor codeRiluzolo
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Spinocerebellar ataxia type 7 (SCA7)
    Atassia spinocerebellare di tipo 7 (SCA7)
    E.1.1.1Medical condition in easily understood language
    Spinocerebellar ataxia type 7 (SCA7)
    Atassia spinocerebellare di tipo 7 (SCA7)
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the two study arms for the proportion of patients who remain stable at SARA score and visual acuity at 18 months respect to run-in.
    Confrontare i due bracci dello studio per la proporzione di pazienti che rimangono stabili al punteggio SARA e acuità visiva a 18 mesi rispetto al run-in
    E.2.2Secondary objectives of the trial
    To evaluate the effect of riluzole on visual function using quantitative ophthalmologic assessments and on SARA score, as continuous values, assessing changes at 18 months compared to run-in.
    To investigate the safety and tolerability of riluzole administered in SCA 7 patients.
    Valutare l'effetto del riluzolo sulla funzione visiva valutata attraverso parametri neuroftalmologici quantitativi e sul punteggio SARA, come valori continui, valutando i cambiamenti a 18 mesi rispetto al run-in.
    Valutare la sicurezza e tollerabilità del riluzolo nei soggetti affetti da atassia spinocerebellare di tipo 7.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male and female of any race and > 6 years old; 2) Positive genetic test for SCA7; 3) Signed Informed Consent (in case of minors, written informed consent must be obtained by parents or legal representative).
    1) Maschi e femmine di ogni razza e di età maggiore di 6 anni; 2) test genetico positivo per SCA 7; 3) firma del consenso informato (in caso di minori, consenso informato firmato dai genitori o dal rappresentante legale).
    E.4Principal exclusion criteria
    1) Female subjects: pregnant or lactating women cannot participate in the study. Women of childbearing potential cannot participate unless willing to use highly effective contraception methods as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study drug. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 2.) Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, severe systemic mycotic infections, metabolic diseases or malignancies; 3) Hepatic diseases with serum values of alanine aminotransferase, aspartate aminotransferase or bilirubin > 1·5 times above normal limit 4) Any medical or psychiatric condition that may affect the subject ability to give informed consent, or to complete the study, or if the subject is considered by the treating neurologist to be, for any other reason, an unsuitable candidate for this study; 5)Known hypersensitivity to any component of riluzole (Glentek).
    1) Soggetti femminili: donne in gravidanza o in allattamento non possono partecipare allo studio. Le donne in età fertile devono assicurare l’uso di contraccezione ormonale combinata (estrogeno e progestinico) associata a inibizione dell'ovulazione (orale, intravaginale o transdermica); contraccezione ormonale progestinica associata a inibizione dell'ovulazione (orale, iniettabile o impiantabile, dispositivo intrauterino (IUD), sistema di rilascio ormonale intrauterino (IUS); chiusura tubarica bilaterale; partner vasectomizzato; astinenza sessuale per tutta la durata dello studio ; 2) qualsiasi condizione medica o chirurgica importante che a giudizio dello sperimentatore comprometta la partecipazione allo studio; 3) patologia epatica con valori dell’alanina aminotransferasi, aspartato aminotransferasi o bilirubina > 1,5 volte i valori normali; 4) Qualsiasi condizione medica o psichiatrica che possa influire sulla capacità del soggetto di dare il consenso informato, o di completare lo studio, o se il soggetto è considerato dal neurologo, per qualsiasi altro motivo, un candidato non idoneo per questo studio; 5) ipersensibilità o allergia ai componenti del riluzolo (Glentek).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints will be the proportion of patients with stable SARA score and visual acuity expressed as log MAR units at 18 months, in comparison with the same parameters as mean of t0-t3-t6 evaluations .
    Gli endpoint primari saranno la proporzione di pazienti con stabilità del punteggio SARA e dell’acuità visiva (in unità MAR log) a 18 mesi, rispetto ai valori medi delle valutazioni a 0-3-6 mesi.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Months: 0, 3, 6, 18
    Mesi: 0, 3, 6, 18
    E.5.2Secondary end point(s)
    The secondary endpoint will be quantitative ophthalmologic assessments (via a Farnsworth D15 Arrangement Test, Visual evoked, Electroretinography, Optical Coherence tomography, Computerized visual field examination) and SARA score as continuous values at 18 months, in comparison with the same parameters calculated for each patient as mean of t0-t3-t6 evaluations; The safety profile will be assessed through the recording, reporting and analyzing of baseline medical conditions, adverse events, physical examination findings including laboratory tests.
    Gli end point secondari saranno le valutazioni quantitative neuroftalmologiche (Farnsworth D15 Arrangement Test, potenziali evocati visivi, elettroretinogramma, OCT, campo visivo computerizzato) e i punteggi della scala SARA come variabili continue a 18 mesi confrontati con gli stessi parametri calcolati per ogni paziente come medie dei punteggi a t0-t3-t6.; Il profilo di sicurezza sarà valutato attraverso la registrazione, la segnalazione e l'analisi delle condizioni mediche di base, gli eventi avversi, i risultati dell'esame fisico compresi i test di laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months: 0, 3, 6, 18; Months: 3, 6, 9, 12, 15, 18
    Mesi: 0, 3, 6, 18; Mesi: 3, 6, 9, 12, 15, 18
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F. of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F. of subjects incapable of giving consent
    Subjects under age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 34
    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)
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Centro Nazionale Malattie Rare - ISS
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
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