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    Summary
    EudraCT Number:2012-002903-16
    Sponsor's Protocol Code Number:2197944/201
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-02-12
    Trial results Removed from public view
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-002903-16
    A.3Full title of the trial
    A randomised, double-blind, crossover study to compare the efficacy and safety of CNV2197944 75 mg tid versus placebo in patients with post-herpetic neuralgia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the safety and efficacy of CNV2197944 in patients with post-herpetic neuralgia
    A.4.1Sponsor's protocol code number2197944/201
    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 codeCB33 3AT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223755501
    B.5.5Fax number+44 1223497114
    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 nameCNV2197944
    D.3.2Product code CNV2197944
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCNV2197944
    D.3.9.1CAS number 1204535-44-3
    D.3.9.3Other descriptive nameCNV2197944C
    D.3.9.4EV Substance CodeSUB32023
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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
    Post-herpetic Neuralgia
    E.1.1.1Medical condition in easily understood language
    Nerve pain due to damage caused by the varicella zoster virus (also known as shingles).
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    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
    To investigate the effect of repeat oral dosing of CNV2197944 75 mg three times daily on the pain experienced in post-herpetic neuralgia (PHN) as measured by changes in pain intensity numerical rating scale after three weeks of treatment compared to the baseline period.
    E.2.2Secondary objectives of the trial
    To investigate the effects of repeat oral dosing of CNV2197944 on pain in patients with PHN.

    To investigate the safety and tolerability of CNV2197944 in patients with PHN.

    To assess the plasma concentrations and exposures of CNV2197944.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent.
    2. 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) > 40 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 the protocol if they wish to continue their HRT during the study.
    • Child-bearing potential and agrees to use one of the contraception methods listed in the protocol 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 the follow-up visit.
    3. Male patients must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the follow-up visit.
    4. Body weight >/= 50 kg for men and >/= 45 kg for women.
    5. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    6. Patients with post-herpetic neuralgia (PHN) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. The maximum duration of PHN will be no longer than 5 years.
    7. Patient’s baseline average daily pain score for neuropathic pain due to PHN on the PI-NRS, calculated as the average of their daily PI-NRS scores over the baseline period (Day 10 to Day 14), is greater than or equal to 4 on the PI-NRSs and no greater than 9, and to have no individual daily score less than 3. Subjects will need to have recorded their daily PI-NRS for a minimum of 4 days during the baseline period. Subjects will not be told what the pain inclusion criteria are.
    E.4Principal exclusion criteria
    1. Patients having other severe pain, which may impair the self-assessment of the pain due to PHN. Any question regarding the acceptability of aetiology of the neuropathic pain should be discussed with the medical monitor.
    2. Skin conditions in the affected dermatome that could alter sensation, other than PHN.
    3. Patients who have undergone neurolytic or neurosurgical therapy including skin excisions for PHN.
    4. Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of Day 1.
    5. Certain medications used to relieve the pain of PHN, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine), are prohibited during the study and must be washed out prior to Day 1. The minimum washout period is 3 days for gabapentanoids; the minimum washout period for carbamazepine is 7 days and the washout period for other prohibited drugs will be calculated as 5-half-lives.
    6. Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin. The dose should fall within the approved regulatory labeling for PHN for this exclusion to apply.
    7. Patients taking more than one medication to treat the PHN pain (paracetamol is permitted as a 2nd medication).
    8. Use of other prohibited medications, as defined in section 9.12 of the study protocol.
    9. History or presence of significant cardiovascular, gastro-intestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs which, in the opinion of the Investigator may interfere with the study procedures or compromise patient safety.
    10. A positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result.
    11. History of regular alcohol consumption during the 6 months prior to screening, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units for male patients and of greater than 14 units weekly or an average daily intake of greater than 2 units for female patients. One unit is equivalent to a half-pint (280 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine.
    12. A significant medical history of recurrent syncope or symptomatic orthostatic hypotension, blackouts, fainting or vaso-vagal attacks during the twelve months prior to screening, or evidence of low blood pressure at screening or baseline (systolic BP < 90 mmHg or diastolic BP < 50 mmHg, mean of triplicate readings) after repeated measurements.
    13. Patients with a history of uncontrolled or poorly controlled hypertension during the twelve months prior to screening, with a systolic BP frequently exceeding 160 mmHg and/or diastolic BP frequently exceeding 100 mmHg, or with evidence of BP greater than 160 mmHg and/or greater than 100 mmHg diastolic, mean of triplicate readings, at screening and baseline after repeated measurement.
    14. A history of second or third degree heart block during the twelve months prior to screening, or evidence of second or third degree heart block on ECG’s recorded at screening and baseline.
    15. At the screening and baseline visit QTcB and QTcF must be <450msec on two out of three ECG recordings taken at 5 minute intervals.
    16. A history of any liver or renal disease during the 12 months prior to screening.
    17. AST, ALT and/or GGT >2x upper limit of normal. Alkaline phosphatase or bilirubin >1.5x upper limit of normal.
    18. Creatinine clearance ≤30 mL/min estimated from serum creatinine, body weight, age and sex using the Cockcroft and Gault equation.
    19. A significant medical history of depression or history of suicidality.
    20. A depression subscale score of >10 on the Hospital Anxiety and Depression Rating Scale.
    21. History or presence of any medical or psychiatric condition, or clinically significant abnormality in vital signs, ECG, laboratory tests, or history of illicit drug use which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
    22. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates participation.
    23. Participation in a clinical trial in which the subject has received an investigational product during the month prior to screening or, in the case of a biological agent with a long half-life, three months.
    24. Exposure to more than four new chemical entities (medications for which no marketing authorisation has been obtained) during the 12 months prior to the first dosing day.
    25. Previous participation in a study involving CNV2197944.
    26. Subject is mentally or legally incapacitated.
    27. Unwillingness or inability to follow the procedures outlined in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    • Change in average daily neuropathic pain score between the third week of treatment and baseline based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable).

    Subjects should specifically rate the pain intensity for the neuropathic pain associated with PHN and not pain from other causes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily from Day 1 to Day 76
    E.5.2Secondary end point(s)
    Efficacy:
    The following endpoints specifically refer to the neuropathic pain from PHN.
    -Change in average daily pain score from baseline over time (weeks 1, 2 and 3 of treatment).
    -Change in Neuropathic Pain Symptom Inventory total score and sub-scales from baseline to week 3 of treatment.
    - ≥ 30% reduction in PI-NRS score after 3 weeks of treatment.
    - ≥ 50% reduction in PI-NRS score after 3 weeks of treatment.
    -Improved Patient Global Impression of Change (PGIC) after 3 weeks of treatment.
    -Improved Clinician Global Impression of Change (CGIC) after 3 weeks of treatment.
    -Use of rescue medication.

    Safety:
    -Incidence, severity, seriousness and relatedness of adverse events.
    -Changes in vital signs.
    -Changes in ECG parameters.
    -Changes in laboratory safety test results (clinical chemistry, haematology, urinalysis) and the incidence of abnormal laboratory test results.

    Pharmacokinetics:
    -Pre-dose and post-dose blood CNV2197944 concentrations – AUC(0-24)-ss, Cmin-ss and Cmax-ss.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints are detailed in the study protocol, Section 10.
    For example, PI-NRS is recorded daily from Day 1 to Day 76.
    Vital signs and ECGs is assessed pre-dose and 1h post dose on Days 1, 15, 22, 36, 50, 57, 71.
    PK samples are taken pre-dose at visits 3 and 6, pre-dose and between 0-1h post-dose at visits 4 and 7, pre-dose and between 2- 3 h post-dose on visits 6 and 8.
    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 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) 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    There is an initial 2-week single-blind placebo phase, followed by double-blind crossover study
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Bulgaria
    Georgia
    South Africa
    Ukraine
    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
    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 months0
    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 months0
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 62
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 110
    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)
    Standard medical care
    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 Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-06
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