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    Summary
    EudraCT Number:2007-001140-47
    Sponsor's Protocol Code Number:M10-014
    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:2007-10-16
    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 number2007-001140-47
    A.3Full title of the trial
    A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of ABT-894 versus Placebo in Subjects with Diabetic Neuropathic Pain
    A.4.1Sponsor's protocol code numberM10-014
    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 SponsorAbbott GmbH & Co. KG
    B.1.3.4CountryGermany
    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 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 nameABT-894
    D.3.2Product code ABT-894
    D.3.4Pharmaceutical form Tablet
    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 876170-44-4
    D.3.9.2Current sponsor codeABT-894, A-422894.112
    D.3.9.3Other descriptive name3-(5,6-dichloro-pyridin-3-yl)-1(S),5(S)-3,6-diazabycyclo[3.2.0]heptane benzenesulfonate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 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 placeboTablet
    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
    diabetic neuropathic pain
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the analgesic efficacy and the safety of ABT-894 (6 mg tablets) administered twice daily (BID) to placebo in the treatment of diabetic neuropathic pain (DNP).
    E.2.2Secondary objectives of the trial
    To explore the pharmacokinetic and pharmacogenetic characteristics of ABT-894 in the DNP population.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics- please refer to Section 5.3.6 'Pharmacogenetic Variables' in Protocol
    E.3Principal inclusion criteria
    1. Subject must voluntarily sign and date an informed consent form, approved by an
    Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to
    the conduct of any study-specific procedures.
    2. Subject is male or female between 18 and 75 years of age (inclusive) at the
    Screening Visit.
    3. The subject must have a score of 3 or greater on the physical assessment portion of
    the Michigan Neuropathic Screening Instrument at the Screening Visit.
    4. At the Baseline Visit the subject must meet the following criteria:
    ● An average score of 4 or greater on the 24-hour average pain score (11-Point
    Likert Scale) collected for approximately 7 days prior to the Baseline Visit,
    and
    ● A compliance rating of no less than 60% on the 24-hour average pain score
    (11 Point Likert Scale) collected over approximately 7 days prior to the
    Baseline Visit.
    5. Subject must have an average of 4 or greater on the BPI average of pain score at
    the Baseline Visit.
    6. Subjects must be able to adhere to the study visit schedule and all other protocol
    requirements, including the completion of daily pain diaries.
    7. If female, subject is either not of childbearing potential (defined as
    postmenopausal for at least two (2) years or surgically sterile [bilateral tubal
    ligation, bilateral oophorectomy or hysterectomy]) or subject is of childbearing
    potential and practicing at least one (1) of the following methods of birth control:
    ● Total abstinence from sexual intercourse is only accepted as a form of effective contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable method of contraception.)
    ● A vasectomized partner
    ● Contraceptives (oral, parenteral or transdermal) for 3 consecutive months
    prior to study drug administration, or use of an intrauterine device
    ● Other acceptable methods (condoms, sponge, diaphragm or vaginal ring with spermicidal jellies or creams) for a minimum of 1 complete menstrual cycle.
    8. If female, subject must have negative results for pregnancy tests performed:
    ● On serum sample obtained at the Screening Visit within 21 days prior to
    initial study drug administration, and
    ● Prior to dosing on a urine sample.
    9. The subject must have a diagnosis of diabetes mellitus (Type 1 or Type 2) and a
    diagnosis of painful distal symmetric diabetic polyneuropathy.
    10. Subject's distal symmetric diabetic polyneuropathy must be present for a minimum
    of six (6) months and should have begun in the feet with relative symmetrical
    onset.
    11. Subject has an HgbA1c result ≤ 11.
    12. Subject must be willing to washout of all analgesics (except stable doses of
    NSAIDs for conditions other than DNP) for at least 5 half-lives of the longest
    acting analgesic or 2 days whichever is longer and be willing to remain off of
    medication during the 7 days prior to the Baseline Visit.
    13. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method (condom) of birth control for the duration of the study and for 7 days following the last dose of study drug.
    E.4Principal exclusion criteria
    1. Subject has a history of an allergic reaction or clinically significant sensitivity or intolerance to acetaminophen or a NNR agonist.
    2. Subject has a medical condition or illness, which is not well controlled that would, in the opinion of the Investigator, preclude study participation or interfere with the
    assessment of pain and other symptoms of DNP.
    3. Subject has a symptomatic diagnosis of fibromyalgia that requires treatment.
    4. Subject is currently receiving analgesics for conditions other than DNP, except for
    stable doses of NSAIDs for a non-neuropathic pain condition (e.g. Osteoarthritis).
    5. Subject has a clinically symptomatic neuropathic pain condition other than DNP.
    6. Subject requires treatment with a NSAID for a non-neuropathic pain condition (e.g., non-elective or COX-2 inhibitors) at a dose that has not been stable for at least 30 days. If the subject is on a stable dose of NSAIDs (> 30 days), inclusion into the study is permitted.
    7. Subject has a functioning implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of neuropathic pain.
    8. Subject has a history of:
    ● Seizures, including those requiring treatment with anticonvulsant. Febrile seizures will be permitted at the discretion of the Investigator.
    ● Major depressive episode within the past two (2) years (as defined by DSMV IV).
    ● Major psychiatric disorder including bipolar disorder, schizophrenia or borderline personality disorder.
    ● Other psychiatric disorders as determined by the Investigator.
    9. Subject has a history of myocardial infarction (MI).
    10. Subject has unstable angina.
    11. Subject has ventricular arrhythmia requiring anti-arrhythmic therapy.
    12. Subject has undergone a cardiac revascularization procedure.
    13. Subject has New York Heart Association (NYHA) functional heart failure classification of Class III or greater.
    14. Has stable angina and has had their anti-anginal medication changed or altered
    within the last 3 months.
    15. Uncontrolled hypertension (HTN) defined as a systolic BP ≥150 and/or a diastolic
    blood pressure ≥ 100 at two consecutive visits (Screening and Baseline).
    16. Subject has a clinically significant abnormal ECG or (QTc) of > 450 ms at Screening.
    17. Subject has any clinically significant infection/injury/illness within thirty (30) days prior to the Screening Visit.
    18. Subject has a newly diagnosed clinically significant medical condition that requires therapeutic intervention (within thirty (30) days prior to the Screening
    Visit) or unstable medical condition that significantly impacts health.
    19. Subject has an active malignancy of any type or has been diagnosed with or treated for cancer within the past 5 years. Subjects with basal cell carcinoma of the skin that has been successfully treated will be allowed to participate.
    20. Subject has an active substance abuse or history of chronic substance abuse within the past year, or prior chronic substance abuse judged likely, by the Investigator, to recur during the study period.
    21. Subject has a positive result for drugs of abuse at Screening with the exception of a positive result for a known prescribed medication.
    22. Subject is consuming more than 4 alcoholic drinks per day.
    23. Subject's screening laboratory results show the presence of Hepatitis B surface
    antigen (HBs Ag), Hepatitis C antibody (HCV Ab), or active Hepatitis A immunoglobulin M antibody (HAV IgM Ab).
    24. Subject has a known or suspected history of Human Immunodeficiency Virus (HIV).
    25. Subject has clinically significant abnormalities in clinical chemistry, hematology,
    or urinalysis, including AST or ALT ≥ 1.5 times the upper limit of the reference
    range, or a serum creatinine > 2.0 mg/dL.
    26. Subject is pregnant and/or breastfeeding or plans to become pregnant as
    documented at the Screening or Baseline visits.
    27. Subject is largely or wholly incapacitated, bedridden, or confined to a wheelchair
    permitting little or no self-care.
    28. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-894.
    29. Subject has received another investigational product within thirty (30) days of the Screening Visit.
    30. Subject requires treatment with a prohibited medication during the course of the
    trial.
    31. Current participation in another clinical study.
    32. Previous participation in this or any other ABT-894 studies.
    33. Subject has a family history of long-QT syndrome or sudden unexplained cardiac deaths.
    E.5 End points
    E.5.1Primary end point(s)
    The weekly mean of 24-hour average pain score measured by the 11-point Likert Scale and calculated from subject's daily diary.
    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 Yes
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    The date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is longer.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months14
    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 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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    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)
    Upon completion of each subject's participation in the study he/she will be returned to 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 Decision2007-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-23
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