Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-004654-30
    Sponsor's Protocol Code Number:BHV4157-209
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-004654-30
    A.3Full title of the trial
    A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder
    Een multicenter, lange termijn open-label veiligheidsonderzoek naar adjuvante troriluzol bij proefpersonen met obsessieve compulsieve stoornis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder
    Langetermijnonderzoek naar de veiligheid van adjuvans troriluzol bij proefpersonen met een obsessieve-compulsieve stoornis
    A.3.2Name or abbreviated title of the trial where available
    Long-term Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder
    Langetermijnonderzoek naar de veiligheid van adjuvans troriluzol bij proefpersonen met een OCD
    A.4.1Sponsor's protocol code numberBHV4157-209
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04708834
    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 SponsorBiohaven Pharmaceuticals, Inc
    B.1.3.4CountryUnited States
    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 supportBiohaven Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAccelsiors CRO and Consultancy Services Ltd.
    B.5.2Functional name of contact pointRegulatory Unit
    B.5.3 Address:
    B.5.3.1Street Address103 Haros Str.
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1222
    B.5.3.4CountryHungary
    B.5.4Telephone number+361299 00 91
    B.5.5Fax number+361299 00 96
    B.5.6E-mailregulatory@accelsiors.com
    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 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 nameTroriluzole
    D.3.2Product code BHV-4157
    D.3.4Pharmaceutical form Capsule
    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 INNTroriluzole
    D.3.9.1CAS number 1926204-76-3
    D.3.9.2Current sponsor codeBHV-4157
    D.3.9.3Other descriptive nameTroriluzole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    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 nameTroriluzole
    D.3.2Product code BHV-4157
    D.3.4Pharmaceutical form Capsule
    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 INNTroriluzole
    D.3.9.1CAS number 1926204-76-3
    D.3.9.2Current sponsor codeBHV-4157
    D.3.9.3Other descriptive nameTroriluzole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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 No
    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
    Obsessive Compulsive Disorder
    E.1.1.1Medical condition in easily understood language
    Obsessive Compulsive Disorder (OCD)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002860
    E.1.2Term Anxiety disorder NEC
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenlafaxine treatment
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed Consent:
    a. Signed informed consent form prior to the initiation of any protocol required procedures.
    2. Age and Sex:
    a. Male and female outpatient subjects between the ages of 18 – 65 upon entry into BHV4157-302 or BHV4157-303.
    3.Target Population:
    a. Eligible subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.
    b.Determined by the investigator to be medically stable at the final visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
    c. Minimum of 6 years of education or equivalent to complete necessary scales and understand consent forms;
    d. Subjects must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
    e. Subjects must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about AEs and concomitant medications;
    f. Women of child bearing potential (WOCBP) and fertile men (including those vasectomized for less than 6 months) with female partners who are WOCBP (not having undergone bilateral tubal occlusion procedure and not post- menopausal) must agree to use highly effective birth control, including two methods of contraception, for the duration of the study.
    g. The two methods should include:
    i. one barrier method (e.g. diaphragm with spermicide, condom with spermicidal gel, intrauterine devices, cervical cap);
    ii. One other method that could include hormonal contraceptives (e.g. combined estrogen and progesterone containing, or progesterone only with oral, vaginal, injectable, or transdermal route of administration), intrauterine device, or intrauterine hormone releasing system used for at least 4 weeks prior to sexual intercourse (Section 5.5);
    h. Women of childbearing potential must have a negative serum pregnancy test throughout the study
    i. It is required that men who are sexually active with WOCBP agree to use two methods of contraception for the duration of the study (beginning at first treatment and extending to 90 days after the last dose of study drug)
    j. No clinically significant abnormality on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the investigator considers that the finding is not clinically significant and will not introduce additional risk factors and will not interfere with the study procedure
    E.4Principal exclusion criteria
    1.Target Disease Exceptions
    a.Subjects who did not successfully complete randomization phase in BHV4157-302/BHV4157-303 study
    b.Current or prior history of bipolar I or II disorder,schizophrenia or other psychotic disorders,schizoaffective disorder,autism or autistic spectrum disorders, borderline personality disorder,antisocial personality disorder,body dysmorphic disorder,hoarding disorder (symptoms of hoarding disorder as part of OCD diagnosis are allowed,but primary diagnosis of hoarding disorder is excluded);current diagnosis of Tourette’s disorder
    c.Any eating disorder within last 12 months
    d.Primary active major depressive episode or primary active anxiety disorder within past 6 months
    e.Acute suicidality or suicide attempt or self injurious behavior in last 12 months
    f.Any positive Columbia Suicide Severity Rating Scale response to questions 1-5 at baseline(final visit of BHV4157-302/BHV4157-303)
    g.Patients who plan to receive non-biological or biological investigational agent in while enrolled in trial
    h.History of psychosurgery,Deep Brain Stimulation or Electroconvulsive Therapy
    2.Medical History Exclusions:
    a.History of substance use disorder(drug or alcohol) in last 12 months,with exception of tobacco,as defined by DSM-5 criteria
    b.A positive urine drug screen for cannabis is not necessarily exclusionary, however, cannabis use, both medical and recreational, is strongly discouraged. A positive urine drug screen for amphetamines (including MDMA/ecstasy), cocaine, barbiturate, PCP, and/or opiates at study entry is exclusionary
    c.Prior or current general medical condition that may confound ability to interpret safety and efficacy results as determined by Investigator
    d.Clinical history of stroke,seizure disorder,traumatic brain injury with ongoing sequelae
    e.Patients with history of Type I or Type II insulin-dependent diabetes mellitus
    f.Active liver disease or history of hepatic intolerance to medications
    g.Any unstable cardiovascular(includes uncontrolled hypertension),pulmonary,gastrointestinal, or hepatic disease at study entry
    h.End-stage cardiovascular disease(e.g.,Congestive Heart Failure New York Heart Association Class III or IV or unstable angina)
    i.History of chronic pulmonary disease or chronic pulmonary symptoms; well controlled asthma is allowed per investigator's clinical judgement;
    j.Immunocompromised subjects.Subjects taking systemic immunosuppressive agent may be entered in trial only if they are on stable dose,have no clinically relevant immunosuppression,and have white blood count within normal limits
    k.History of medically significant gastrointestinal illnesses including:i.Current diagnosis of active,peptic ulceration or gastrointestinal bleeding and/orchronic inflammatory bowel disease at study entry;ii.History of any gastrointestinal surgery that impacts absorption of study drug;iii.Chronic or frequent episodes of loose stools
    l.History or evidence of any medical,neurological or psychological condition that would expose subject to undue risk of significant AE or interfere with assessments of safety and efficacy during study course
    m.Women who are pregnant or breastfeeding
    3. Physical and Laboratory Test Findings
    a.Uncontrolled hypertension at study entry(e.g.,repeated diastolic measurements ≥ 96mmHg)
    b.Hepatic test abnormalities at study entry(last visit of BHV4157-302/BHV4157-303):i.Aspartate Aminotransferase, Alanine Aminotransferase or GGT > 3 times upper limit of normal or ii.Total bilirubin > 2 times upper limit of normal;unless subject has documented history of Gilbert’s Syndrome in which case subject may be enrolled if total bilirubin is less than 5 mg/dL,assuming all other criteria are fulfilled
    d.Creatinine ≥ 2 mg/dL at study entry
    e.Hematologic abnormalities at study entry: i. Hemoglobin < 10 g/dL; or ii. WBC < 3.0 x 103/mm3; or iii. Platelet count < 100,000/mm3. iv. Neutrophils, Absolute < 1500/mm3
    f.QTcF (Fridericia) interval ≥ 470 msec during study period or uncontrolled arrhythmia or frequent premature ventricular contraction (PVCs) (> 5/minute) or Mobitz Type II second or third degree atrioventricular (AV) block or left bundle branch block,or right bundle branch block with a QRS duration ≥ 150 msec or intraventricular conduction defect with QRS duration ≥ 150 msec or evidence of acute or sub-acutemyocardial infarction or ischemia or other ECG findings that,in investigator’s opinion,would preclude participation in study
    4.Prohibited Treatments and/or Therapies
    a.Previous treatment with riluzole
    b.Patients who would likely require prohibited concomitant therapy after study entry
    c.Herbal medication and supplement use during the course of study is prohibited
    d.Transcranial Magnetic Stimulation is prohibited during study
    e.Subjects who are participating in any other clinical research study.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability are assessed using the frequency of unique subjects with: SAE; AEs leading to discontinuation; AEs judged to be related to study medication; and clinically significant laboratory abnormalities that are observed from baseline to week 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    E.5.2Secondary end point(s)
    none
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    multicenter
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United Kingdom
    United States
    Italy
    Netherlands
    Spain
    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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days28
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 1080
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 1200
    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)
    Subjects will return to previous standard of care treatment.
    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 Decision2021-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 23:22:52 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA