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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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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    EudraCT Number:2007-003787-21
    Sponsor's Protocol Code Number:201781-504
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-08-21
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2007-003787-21
    A.3Full title of the trial
    A Pilot, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with a 4-Week Treatment Period Followed by a 4-week Observation Period and an Optional 4 Month Observation Period of the Safety and Duration of Efficacy of AGN 201781 in Subjects with Neuropathic Pain
    A.4.1Sponsor's protocol code number201781-504
    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 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 support
    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 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 nameAGN 201781 50 mg capsule
    D.3.2Product code 9848X
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 628730-35-8
    D.3.9.2Current sponsor codeAGN 201781
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 No
    D.3.11.8Extractive medicinal product No
    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, 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
    Postherpetic neuralgia or post-traumatic peripheral 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 assess the safety and explore the duration of analgesia with AGN 201781 in the treatment of pain associated with postherpetic neuralgia and post-traumatic peripheral neuralgia.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has provided written informed and Data Protection consent prior to initiating any study specific screening procedures.
    2. Males or females (non-child bearing potential, defined as post-menopausal for at least 12 months, hysterectomy or bilateral oophorectomy), 18 – 80 years of age.
    3. Clinical diagnosis of one or the other of the following neuropathic pain conditions:
    • Postherpetic neuralgia (PHN) present for a minimum of 6 months after onset of rash.
    • Post-traumatic peripheral neuralgia [Mechanical injury (including surgical injury) to peripheral nerves/root e.g. stabbing or burning pain that persists to a varying degree within the affected or adjacent area of trauma or corresponding dermatome for 6 months or more after the precipitating insult].
    4. Subjects with history of cancer (except basal cell carcinoma) should be in complete remission (defined by NCI as follows: all signs and symptoms of cancer have disappeared, although cancer still may be in the body) for at least 12 months prior to baseline and throughout the baseline period.
    5. Subject has pain defined as:
    • A mean daily-average-pain score of at least 4 and no greater than 9 on the 11 point Likert Scale during the last 7 days of the baseline period.
    • Subject must complete their pain diaries for at least 6 of the last 7 days of the baseline period.
    • PHN or post-traumatic peripheral neuralgia is the subject’s predominant pain condition and he/she is able to distinguish between the neuropathic pain and other concurrent painful conditions.
    6. The subject must be able to understand and cooperate with study requirements, including e-diary administration and willing and able to complete the entire course of the study.
    7. Subject is eligible for enrollment as determined by the investigator from medical history, physical examination findings, 12-lead electrocardiograph (ECG) findings, and clinical laboratory test results. Laboratory results outside of the reference range must be documented as acceptable by the investigator. In addition, the liver function tests, thyroid function tests and creatinine clearance (calculated) must be within the specific ranges below:
    • ALT and AST < 1.5 times the upper reference range
    • Creatinine Clearance (calculated) > 70 mL/min
    • FT3 and FT4 > lower reference range or < 1.1 times the upper reference range
    • TSH within normal reference range

    E.4Principal exclusion criteria
    1. Uncontrolled concurrent disease.
    2. Pain resulting from injury to the spinal cord or central neuropathic pain (e.g. post-stroke) as indicated by medical history and clinical evaluation (e.g. pain evident at more than one dermatome below the level of the neurologic lesion).
    3. Post-traumatic peripheral neuralgia with evidence of an ongoing insult to the nerve (e.g. nerve compression as a result of a herniated disc).
    4. Any significant disease or other significant abnormal findings at the screening and or baseline evaluation, as determined by the investigator.
    5. History of treatment for, or evidence of, alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of 3 units of alcohol per day (Attachment 13.3).
    6. Beck Depression Inventory (BDI) score >20 at baseline.
    7. Subject with a score of ≥ 2 on question 9 (suicide) of Beck Depression Inventory at baseline visit, or is deemed by the investigator to be at risk of significant self harm.
    8. Use of topical capsaicin within 4 weeks prior to the start of the baseline period and throughout the baseline period.
    9. Concurrent treatment or history of treatment within 2 weeks prior to the start of the baseline period and throughout the baseline period with the following:
    • Tricyclic antidepressants (TCAs) (e.g. amitriptyline)
    • Serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g. duloxetine)
    • Alpha-adrenergics - agonists or antagonists (e.g. clonidine)
    • Monoamine oxidase (MAO) inhibitors (e.g. tranylcypromine)
    • Opioids including tramadol (e.g. oxycodone)
    • Topical analgesics (e.g. lidocaine)
    • Antiarrhythmics or NMDA antagonists (e.g. mexiletine)
    • Benzodiazepines (e.g. diazepam)
    • Muscle relaxants (e.g. baclofen)
    In addition, concurrent treatment or history of treatment within 24-hours prior to the start of the baseline period and throughout the baseline period with acetaminophen (Tylenol).

    10. Concurrent treatment or history of treatment for cancer including radiation therapy, chemotherapy, etc. (except for non-chemotherapy adjuvant therapy, e.g. exemestane), within the last 12 months prior to the start of the baseline period and throughout the baseline period.

    11. Subject being treated with an anti-convulsant (e.g. gabapentin) and/or NSAIDS (e.g. acelofenac), and is NOT on a stable dose for at least 3 weeks prior to the start of the baseline period and throughout the baseline period.

    12. Significant changes in the doses of current chronic medications except for the washout medication(s) within 4 weeks of baseline and throughout the baseline period.

    13. Participation in an investigational drug or device study or participation in such a study within 30 days of screening and/or between screening and randomization.

    14. Exposure to botulinum toxin (of any serotype) in the area affected by neuropathy within the previous 6 months prior to the start of the baseline period and throughout the baseline period.

    15. History of gastrointestinal (GI) conditions or gastric motility disorders that could affect drug absorption.
    16. Subjects with a history of gastrointestinal bleeding or gastric ulcers.
    17. Any allergic reaction to any compound or chemical class related to AGN 201781 (alpha-2 agonists) or its excipients.
    18. Any allergic reaction to Ibuprofen
    19. Subjects on anticoagulant therapy
    20. Subject has a positive test for the presence of Hepatitis C virus antibodies (HCAb), Hepatitis B surface antigen or human immunodeficiency virus (HIV) antibodies at the screening visit.

    21. Active herpes zoster. (HZ) based on characteristic dermatomal distribution and the evolution of the HZ vesicular rash or antibody titres.
    22. Previous neurolytic or neurosurgical therapy for their neuropathic pain (e.g. radiofrequency lesioning)
    23. Concurrent or treatment with methimazole/carbimazole or thiouracils (propyl-methyl or benzylthiouracil) within 12 months of baseline and throughout the baseline period.
    24. Subjects with a diagnosis of hypothyroidism and on current hormone replacement therapy (thyroxine).
    25. Within 12 months of baseline, subject has received a thyroidectomy or radio-iodine therapy for hyperthyroidism.
    26. Subject has a glucose-6-phosphate dehydrogenase deficiency.
    27. Males with pregnant partners must be willing to abstain from sexual intercourse with such partners from the time of taking the first dose of study drug until Visit 11 (Day 58).
    28. Males who are not using or willing to use a double-barrier method of contraception when participating in sexual intercourse with women of childbearing potential (regardless of use of any other methods) from the time of taking the first dose of study drug until Visit 11 (Day 58).
    29. Subject has any other condition or is in a situation which, in the investigator’s opinion puts the subject at significant risk, may confound the study results, or may interfere significantly with the subject’s participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Daily-average pain score [11-point Likert scale, question 1 on the electronic diary (eDiary)]
    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 Yes
    E.6.13.1Other scope of the trial description
    duration of efficacy
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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. 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 No
    E.8.1.7Other Yes
    E. trial design description
    3-Period study followed by an optional 4-month observation period
    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 concerned6
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA6
    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 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
    Completion of the last subject
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 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 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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 40
    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)
    Routine medical practice
    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 Decision2007-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-06-20
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