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    Summary
    EudraCT Number:2010-020977-18
    Sponsor's Protocol Code Number:214868-002
    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:2010-07-26
    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 number2010-020977-18
    A.3Full title of the trial
    A Multicenter, Double-blind, Randomized, Placebo-controlled, Repeat Treatment (two cycle) Study of the Safety and Efficacy of AGN-214868 in Patients with Postherpetic Neuralgia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Double-blind, Randomized, Placebo-controlled, Repeat Treatment (two cycle) Study of the Safety and Efficacy of AGN-214868 in Patients with Postherpetic Neuralgia
    A.4.1Sponsor's protocol code number214868-002
    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 SponsorAllergan 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 supportAllergan Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressMarlow international, the Parkway
    B.5.3.2Town/ cityMarlow
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044(0)1628494444
    B.5.5Fax number+44(0)1628 494449
    B.5.6E-mailml-eu_reg_affairs@allergan.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 nameEndopeptidase
    D.3.2Product code AGN-214868
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    Subcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeA recombinant fusion protein
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntradermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Phase II study to investigate the safety and efficacy of AGN-214868 compared to placebo in the treatment of postherpetic neuralgia The study will look at patients with postherpetic neuralgia (PHN) of at least 9 months duration after the onset of a herpes zoster skin rash who have an area of pain affecting either the cervical, thoracic, lumbar, or sacral dermatomes.
    E.1.1.1Medical condition in easily understood language
    patients with postherpetic neuralgia (PHN) after the onset of a herpes zoster skin rash who have an area of pain affecting either the cervical, thoracic, lumbar, or sacral dermatomes
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    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 evaluate the safety and efficacy of AGN-214868 compared to placebo in the treatment of postherpetic neuralgia (PHN)
    E.2.2Secondary objectives of the trial
    None
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent has been obtained. 2. Written Authorization for Use and Release of Health and Research Study Information (US sites only) and written Data Protection consent (EU sites only) has been obtained. 3. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable. 4. Male or female, 18 to 80 years of age inclusive. Females must be of non reproductive potential 5. Males must agree for the duration of the study to use a condom during sexual intercourse with female partners who are of reproductive potential and to have their female partners use an additional effective means of contraception (eg, diaphragm plus spermicide or oral contraceptive), or the male patient must agree to abstain from sexual intercourse. 6. Females considered of non-reproductive potential are defined as females who are post-menopausal (women ≥ 47 years of age who have been amenorrheic for at least 12 consecutive months), or females who do not have a uterus. Females with bilateral tubal ligation and/or both ovaries removed can also be entered into the study. 7. Clinically acceptable laboratory test results at screening (visit 1) 8. Patient has persistent PHN with pain present for at least 9 months after the onset of a herpes zoster skin rash affecting the cervical, thoracic, lumbar, or sacral dermatomes. 9. A maximal area of spontaneous pain that is less than or equal to 250 cm2 at screening 10. A stable dose of no more than one chronic pain drug that belongs to the following classes: 1) antiepileptic drugs, 2) antidepressant drugs, or 3) chronic opioids not to exceed 120 mg morphine equivalent per day at screening. Administration of drugs for conditions other than chronic pain (eg, epilepsy, depression), which can also reduce chronic neuropathic pain should be considered a pain medication. Patients on no chronic pain medication are acceptable 11. Stable chronic dose of pain medication, if any, for at least 28 days prior to the baseline period 12. Willing and able to stay on current chronic pain medication during the course of the study 13. Ability to follow study instructions and likely to complete all required visits and assessments 14. Average pain rating for the past week of at least 4 on the 0 to 10 numerical rating scale (NRS) at screening 15. Satisfactorily completed diary information on at least 4 out of 7 diary entries from day -7 to day -1 16. Average pain intensity score of at least 4 on the NRS (0 to 10 point numerical rating scale) during the baseline period (ie, days -7 to -1)
    E.4Principal exclusion criteria
    1. Uncontrolled systemic disease other than PHN 2. Female patients with reproductive potential (see Inclusion Criterion 6 for the definition of reproductive potential) 3. Evidence of active liver disease or abnormal liver function tests. Liver function tests above 1.5 times normal must be approved by the medical monitor. 4. Neuropathic pain other than that related to PHN 5. PHN affecting the trigeminal areas or the scalp 6. Other severe pain that may potentially confound PHN pain assessment in the opinion of the investigator 7. Moderate to severe depression (Beck Depression Inventory-II > 19) 8. Active herpes zoster skin rash 9. Previous neurolytic or neurosurgical therapy for PHN 10. Failed to respond (ie, no reduction in pain) to 2 or more classes of treatment for PHN (eg, antiepileptics, antidepressants, opioids) 11. Current (within 30 days) or anticipated treatment with acupuncture, TNS, trigger point injection, or oral and parenteral steroids 12. Current or anticipated use of topical analgesic agents (eg, lidocaine patch within 30 days, or capsaicin cream within 6 months) for PHN 13. Anticipated need for alteration of existing chronic pain medication dosage during the study 14. Current or anticipated need for botulinum toxin therapy of any serotype for any condition, or immunization to any botulinum toxin serotype 15. Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks before screening 16. History of treatment of the area of PHN with high dose capsaicin patch (8% capsaicin) in the prior 6 months 17. Currently on doses of chronic opioids in excess of 120 mg per day of morphine equivalent 18. Known allergy or sensitivity to the study medication or its components 19. Known history of HIV infection and/or HIV sero-positive 20. Abnormal screening laboratory results for hepatitis B surface antigen, hepatitis C antibodies 21. Treatment for, and/or evidence of, alcohol or drug abuse within the past year 22. Is currently enrolled in a trial of an investigational drug or device, or has received any investigational drug within 60 days before the baseline period, or at least 5 elimination half-lives (whichever is longer) 23. Patient has a maximal area of spontaneous PHN pain greater than 250 cm2 (ie, requires more than 65 injections to treat the area(s) of PHN spontaneous pain). 24. Patient has an area of spontaneous PHN pain in the cervical dermatome that extends above the hairline. 25. Evidence of active skin infection or inflammation at the anticipated injection site 26. Patient has a medical condition, or is in a situation, which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: The primary efficacy measure is the daily average pain intensity scored on a NRS reported in the patient eDiary. The primary efficacy variable is the change from baseline of the average pain intensity score based on the daily average pain intensity reported during the 7 days prior to the target day of each visit. The primary time point is at week 12 after treatment 1. Pharmacokinetics (PK): Patients will have a total of 4 PK blood samples (approximately 10 mL per sample) collected after treatment 1 and treatment 2 during one of two collection windows. a subset of approximately 40 patients extensive PK blood samples (approximately 10 mL per sample) will be collected for PK assessments at approximately 2, 5, 8, 24, 48, 72, 96 and 120 hours post-dose for treatment cycles 1 and 2. Plasma AGN 214868 concentrations will be measured using a validated assay Immunogenicity: Blood samples (approximately 20 mL per sample) will be collected from each patient during treatment cycles 1 and 2 for the detection of anti-AGN-214868 antibodies using available validated assays. Safety: Adverse events, physical examination, vital signs including oral body temperature, ECG, and clinical laboratory tests (blood chemistry and hematology [non-fasting], urinalysis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Ref E.5.1
    E.5.2Secondary end point(s)
    None
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 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 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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Czech Republic
    Germany
    Poland
    United States
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    E.8.9.2In all countries concerned by the trial months12
    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.1.3Elderly (>=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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 117
    F.4.2.2In the whole clinical trial 280
    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)
    The 12-week follow-up period following the second treatment cycle allows for suitable post-treatment patient safety monitoring. End of study for each individual will occur after all planned study procedures have been completed. Patients may have follow-up safety assessments after the end of study if required due to significant clinical or laboratory test abnormalities, until the time at which the abnormality is considered resolved or clinically stable.
    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 Decision2010-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-19
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