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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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).

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    Summary
    EudraCT Number:2004-000975-32
    Sponsor's Protocol Code Number:N01162
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-25
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-000975-32
    A.3Full title of the trial
    An exploratory, double blind, randomized, placebo-controlled, parallel group, multicenter study, for the assessment of efficacy, safety and tolerability of ucb 34714 50 mg oral capsules in b.i.d. administration at the doses of 200 mg/day and 400 mg/day, in subjects (at least 18 years old) suffering from post-herpetic neuralgia (PHN)
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code numberN01162
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUCB S.A. Pharma Sector
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameucb 34714
    D.3.2Product code ucb 34714
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNBrivaracetam
    D.3.9.1CAS number 357336-20-0
    D.3.9.2Current sponsor codeucb 34714
    D.3.9.3Other descriptive name(α1S, 4R)-α-ethyl-2-oxo-4-propyl-1-pyrrolidineacetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50mg
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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*
    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
    MedDRA Classification
    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 efficacy of each dose of ucb 34714 (200 mg/day and 400 mg/day)
    compared with placebo, in the treatment of Post-herpetic Neuralgia.
    E.2.2Secondary objectives of the trial
    To explore the safety and tolerability of ucb 34714 in the same indication.

    Exploratory objectives
    To explore the impact on subject’s self-reported health status.
    To collect data on pain free days and on medical resources used during the study.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Written informed consent signed and dated by the subject.
    • Male/female subject aged 18 years or older.
    • Pain present for at least 6 months after healing of the acute herpes zoster skin rash.
    • Pain intensity score assessed on an 11-point numerical pain rating scale with a score of at least 4 at the screening visit (to assess pain intensity during the past 24 hours) and with an average weekly score of at least 4 on an 11-point numerical pain rating scale during baseline period as evaluated on a minimum of 4 days.
    • If the subject is female, the subject must be post-menopausal for at least two years, or surgically sterile (hysterectomy, bilateral tubal ligation, bilateral salpingectomy, congenital sterility or bilateral oophorectomy), or using a medically acceptable method of birth control for the duration of trial participation (intrauterine device, diaphragm plus spermicide, male condom plus spermicide, female condom) or must have a monogamous relationship with a vasectomized partner. Subjects using hormonal contraceptive can be included in the trial if taking OCs containing ≥ 30µg ethinylestradiol. Abstinence will be considered as an acceptable method of contraception on a case-by-case basis upon discussion between the Investigator and UCB or its representative. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status.
    • Be considered as reliable and capable of adhering to the protocol, according to the judgement of the Investigator, e.g. able to understand and complete diaries and questionnaires.
    E.4Principal exclusion criteria
    • Subject getting any kind of psychological support to help cope with pain such as biofeedback or behavioral cognitive therapy. Subjects being followed by a psychologist as part of their multidisciplinary care off can be included, provided that this support started at least 6 months before the screening visit.
    • Subject who had undergone or who is scheduled for neurolytic or neurosurgical therapy for PHN or who receives TENS (trans-electrical neural stimulation).
    • TCAs or non-steroidal anti-inflammatory drug (NSAIDs) or permitted opioid analgesics, that started less than 30 days and/or not stabilized prior to screening and/or not expected to be kept at stable dose over the trial period.
    • Intake of more than two pain treatments at trial entry (screening visit) including TCAs, NSAIDs or permitted opioid analgesics, started at least 30 days and stabilized prior to the screening visit.
    • Subject being treated with Carbamazepine for any indication.
    • Subject with history of severe adverse hematologic reaction to any drug.
    • Subject with history of bone marrow depression.
    • Presence of any sign (clinical or paraclinical) suggesting rapidly progressing brain disorder, dementia or brain tumor.
    • Known significant neurological disorder or a condition that can mimic stroke with distal neurological deficit, amyotrophy, radiculopathy, history of transient ischemic attacks, multiple sclerosis, or any amputations.
    • Subject with conditions known to be associated with immunodepressive states (e.g. HIV subject if known by the Investigator).
    • Clinically significant ECG abnormalities.
    • Any significant clinical and/or medical conditions (acute or chronic illness such as but not restricted to: severe cardiac dysfunction, bone marrow depression, severe hepatic disease and/or moderate to severe renal impairment) which may contraindicate the use of ucb 34714, impair reliable participation in the trial or necessitate the use of medication not allowed by protocol.
    • Known coexistent source of painful peripheral neuropathy such as paraproteinemia, untreated hypoparathyroidism, vitamin B12 deficiency, amyloidosis, connective tissue disease, porphyria, diabetic peripheral neuropathy, complex regional pain syndrome, alcoholism, uremia, syphilis, myeloma, malignancy (less than 5 years in remission), peripheral nerve trauma (including surgery), drug induced peripheral neuropathy (e.g. vinca alkaloids, taxols, etc.) or other systemic disease associated with a secondary painful neuropathy.
    • Subject having clinically significant deviations from reference range values for laboratory parameters, such as hepatic markers (ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, γGT) > 3 x UNL, platelets < 100,000/µl, leukocyte count < 3500 / mm3 or neutrophil cells < 1,800/µl. The non-clinically significant abnormalities for hepatic markers (< 3 x UNL) have to be documented as stable for at least 6 months.
    • Subject having a creatinine clearance < 50 mL/min or a history of significantly impaired renal function.
    • Subject being treated in the four weeks prior to screening visit with “strong” opioid analgesics (e.g. morphine, hydromorphone, oxymorphone, methadone, levomethadyl acetate, meperidine, fentanyl group, levorphanol, bezitramide, buprenorphine, butorphanol, dextromoramide, piritramide).
    • Subject being treated in the two weeks prior to screening visit with: skeletal musclerelaxants, AEDs, mexiletine, anesthetics, topical analgesics, antiviral agents.
    • Subject being treated in the week prior to screening visit with: any other treatment considered efficacious in the treatment of post-herpetic neuralgia. Aspirin ≤ 300 mg/day may be taken for the prophylaxis of myocardial infarction or transient ischemic attacks.
    • Subject treated with over-the-counter and/or homeopathy analgesics.
    • Pregnant, lactating or sexually active woman with childbearing potential who is not using a medically accepted birth control method or who is using an OC containing < 30µg ethinylestradiol, in case she is taking hormonal contraception.
    • Known psychiatric condition (including suicidal ideation in past three months or history of attempted suicide in the past ten years).
    • Subject having a past history (within the past year) or is currently abusing alcohol or any other drug according to the DSM-IV criteria for drug and alcohol abuse.
    • Contraindication to any component of the treatments in the trial (ucb 34714 or placebo) or known allergic reaction to or intolerance of pyrrolidine derivates and/or other excipients (principally lactose, cornstarch, cellulose).
    • Subject currently participating or having participated within the last 30 days in another clinical trial.
    • Investigators, co-investigators, their spouses or children or any trial collaborator may not be included as subjects in the trial.
    • Subject having been blood donator during the previous 3 months or planning to be blood donator during the trial.

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the percent change in the average pain intensity score on an
    11-point numerical pain rating scale from the Baseline Period to the last week of the
    Treatment Period.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    UCB has decided to establish as end of the trial the date of "Database Lock" since this implies that all the case report forms from the recruited subjects have been monitored and that all discrepancies that might have arise after entering the information on the trial database have been solved leading to have a "clean" database.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-02-25. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 Decision2005-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
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