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    Summary
    EudraCT Number:2010-023963-16
    Sponsor's Protocol Code Number:1014802/202
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-11
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2010-023963-16
    A.3Full title of the trial
    A Placebo-Controlled, Double-Blind Randomized
    Withdrawal Study to Evaluate the Safety and Efficacy of
    CNV1014802 in Patients with Trigeminal Neuragia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the effect of a drug called CNV1014802 on intense face pain and how safe the drug is
    A.4.1Sponsor's protocol code number1014802/202
    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 SponsorConvergence Pharmaceuticals Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportConvergence Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConvergence Pharmaceuticals Ltd
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressMaia Building, Babraham Research Campus
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB22 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004401223755501
    B.5.5Fax number004401223497114
    B.5.6E-mailinfo@convergencepharma.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 nameCNV1014802
    D.3.2Product code CNV1014802
    D.3.4Pharmaceutical form Film-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 INNCNV1014802
    D.3.9.2Current sponsor codeCNV1014802
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 nameCNV1014802
    D.3.2Product code CNV1014802
    D.3.4Pharmaceutical form Film-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 INNCNV1014802
    D.3.9.2Current sponsor codeCNV1014802
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Trigeminal neuralgia
    E.1.1.1Medical condition in easily understood language
    Intense face pain
    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 LLT
    E.1.2Classification code 10029227
    E.1.2Term Neuralgia trigeminal
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of repeat oral dosing of CNV1014802 on the pain experienced in
    trigeminal neuralgia
    E.2.2Secondary objectives of the trial
    • To investigate the safety and tolerability of
    CNV1014802 in patients with trigeminal neuralgia
    • To assess the plasma concentrations and exposures of CNV1014802
    • To assess the use of the Brief Pain Inventory – Facial as an assessment measure for quality of life in trigeminal neuralgia

    Exploratory Objectives
    • Pharmacokinetic-pharmacodynamic relationships, if data permit.
    • To investigate the effect of CNV1014802 on cognitive function in trigeminal neuralgia
    • To compare the tolerability of CNV1014802 to other treatments for trigeminal neuralgia
    • To explore the frequency of genetic mutation in sodium and calcium channels in TGN and the relationship to response to CNV1014802
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible for inclusion in this study only if all of the following criteria apply:
    1. IHS criteria for trigeminal neuralgia to be used. The diagnosis must be verified by a member of the diagnostic sub-committee of the DMC before the patient is entered into the study.
    A diagnosis of trigeminal neuralgia. Pain must be unilateral, and characterized by brief electric shock-like pains, abrupt in onset and termination, limited to the distribution of one or more divisions of the trigeminal nerve. Pain is commonly evoked by trivial stimuli including washing, shaving, smoking, talking and/or brushing the teeth(trigger factors), and frequently occurs spontaneously. The attacks start and end rapidly. There is often no pain between each bout of pain and many bouts can occur every day. There is often a refractory period between attacks. Some patients may report some after pain after the severe pain for a few minutes.
    Pain remissions occur where there can be weeks or months of no pain even when medications are stopped.
    The following diagnostic criteria for trigeminal neuralgia must be met:
    a. Paroxysmal attacks of pain lasting from a fraction of a second to 2
    minutes, affecting one or more divisions of the trigeminal nerve and
    fulfilling criteria b and c.
    b. Pain has at least one of the following characteristics:
    i. Intense, sharp, superficial or stabbing
    ii. Precipitated from trigger areas or by trigger factors
    c. Attacks are stereotyped in the individual patient
    d. There is no clinically evident neurological deficit
    e. Not attributed to another disorder
    2. Frequency criteria for numbers of paroxysms:
    • Patients must have suffered a minimum of 3 or more paroxysms of pain per day, rated at an intensity of 4 or more on the pain NRS, on at least 4 days during the last 7 days prior to entry into the open-label treatment period.
    3. Male or female between 18 and 80 years of age inclusive, at the time of signing the informed consent.
    4. A female patient is eligible to participate if she is of:
    • Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) ≥ 25.8 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].
    Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 7.5 if they wish to continue their HRT during the study.
    • Child-bearing potential and agrees to use one of the contraception methods listed in Section7.5 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female patients must agree to use contraception until 3 days post-last dose.
    5. Male patients must agree to use one of the contraception methods listed in Section 7.5. This criterion must be followed from the time of the first dose of study medication until 14 days post-last dose.
    6. Body weight ≥ 50 kg for men and ≥ 45 kg for women.
    7. BMI ≤34.9.
    8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to the commencement of any study related procedures.
    9. Three ECGs taken at least 5 min apart should be performed at Screening. QTcF < 450 msec in at least two of the three ECGs .
    10. AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    11. Approved concomitant medications must have been stable for at least 3 weeks prior to day 0.
    E.4Principal exclusion criteria
    • Patients who are known non-responders to sodium channel blockers at therapeutic doses.
    • Patients with causes for their facial pain other than that specified in Inclusion Criterion
    • A positive pre-study drug screen.
    • A positive history of HIV.
    • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
    • History of any liver disease within the last 6 months, with the exception of known Gilbert’s disease.
    • History of excessive regular alcohol consumption within 6 months of the study.
    • Patients with a history or risk of seizures or a history of epilepsy, head injury or related neurological disorders
    • Patients with a history of uncontrolled or poorly controlled hypertension, with systolic BP frequently exceeding 160mmHg and/or diastolic BP frequently exceeding 100mmHg, or patients who have BP greater than or equal to 160mmHg systolic and/or greater than
    or equal to 100mmHg diastolic at screening after repeated measurements
    • History or presence of significant cardiovascular, gastrointestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism,
    or excretion of drugs.
    • Patients with conditions known to affect cardiac conduction or a personal or familial history of Brugada syndrome
    • Pregnant females or lactating females.
    • History or presence of any clinically significant
    abnormality in vital signs / ECG / laboratory tests or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study
    procedures or compromise patient safety.
    • History of suicidal ideation and/or suicide attempts or clinical evidence of recent major depression.
    • Patients who are unable to maintain approved
    medications for their trigeminal neuralgia at a stable dose during the study.
    • Unable to refrain from excessive use of sedatives.
    • Unable to comply with the prohibited concomitant medication restrictions as detailed in the protocol. This includes but is not limited to sodium channel blockers or drugs that adversely interact with a monoamine oxidase-
    B inhibitor: MAOI’s, antidepressants, opioids and sympathomimetic agents.
    • History of hypersensitivity to CNV1014802.
    • The patient has participated in a clinical trial and has received an investigational product within 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to the start of this study.
    • Exposure to more than four new chemical entities (medications for which no marketing authorization has been obtained) within 12 months prior to the first dosing day.
    • Where participation in the study would result in total donation of blood or blood products in excess of 500mL within a 56 day period.
    • Patient is mentally or legally incapacitated.
    • Unwillingness or inability to follow the procedures outlined in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Patients will be classified as a treatment failure if they meet one of the following criteria:

    • 50% increase in the frequency of paroxysms compared to the final 7 days of the open-label period, to more than 3 paroxysms within a 7 day period
    • When more than 3 paroxysms are reported in a 7 day period, 50% increase in the severity of pain experienced in the paroxysms compared to the final 7 days of the open-label period
    • A Patient Global Improvement of Change rating of much worse/very much worse
    • The patient discontinues the study due to ‘Lack of Efficacy’
    • The patient discontinues due to an adverse reaction or poor tolerability considered to be
    related to study medication
    E.5.1.1Timepoint(s) of evaluation of this end point
    The frequency and the severity of paroxysms will be recorded on a daily basis by the patient. The patient and clinician global impression of change rating will be determined on Day 21 and Day 49.
    E.5.2Secondary end point(s)
    Efficacy Endpoints:
    • Number and severity of paroxysms of pain in the 21 day open-label period both evoked and spontaneous.
    • Average 24 hour pain intensity numerical rating scale (PI-NRS)
    • Patient and Physician Clinical Global Impression of Change
    • Brief Pain Inventory – Facial
    Pharmacokinetics:
    • Pre-dose and post-dose plasma CNV1014802 concentrations – AUC-ss, Ctrough-ss and Cmax-ss

    Safety:
    • Adverse events
    • Vital signs
    • ECG parameters
    • Laboratory safety tests (clinical chemistry, haematology, urinalysis)

    Exploratory Endpoints:
    • Assessing PK-PD relationship, if data permit.
    • Cognitive function using the Medical Outcome Study - Cognitive Scale
    • Adverse event profile (AEP) scale
    • Presence of genetic mutations in sodium channel (Nav1.1, Nav1.2, Nav1.3, Nav1.6 and Nav1.7) or calcium channel (Cav2.2 and Cav2.1) genes (optional for patients).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The frequency and the severity of paroxysms will be recorded on a daily basis by the patient. The patient and clinician global impression of change rating will be determined on Day 21 and Day 49. The brief pain inventory - facial will be determined on Day 0, 21, 49 and 56. Pharmacokinetics will be assessed on Day 0, 7, 21, 35 and 49. Vital signs and ECGs will be assessed in screening and on Day 0, 7, 14, 21, 28, 35, 42, 49 and 56.Lab safety samples will be taken in screening and on Day 0, 7, 21, 35, 49 and 56. Cognitive status will be assessed on Day 0, 21 and 49. Adverse event profile scale will be determined in screening and on Day 21 and 49. Adverse events will be collected throughout. The genotype sample can be collected on Day 1 or can be collected later in the study
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Randomised withdrawal design
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Denmark
    Estonia
    France
    Germany
    Italy
    Latvia
    Lithuania
    Romania
    South Africa
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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 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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 70
    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)
    Patient will revert back to their initial drugs or may opt for surgical management after completion of the study because this drug is not approved for treatment of trigeminal neuralgia.
    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 Decision2012-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-26
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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