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    Summary
    EudraCT Number:2007-007764-14
    Sponsor's Protocol Code Number:XTL B07-002
    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:2008-04-08
    Trial 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 number2007-007764-14
    A.3Full title of the trial
    An Open-label 52-Week Safety Study of Bicifadine SR in Adult Outpatients with Chronic Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
    A.4.1Sponsor's protocol code numberXTL B07-002
    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 SponsorXTL Development Inc.
    B.1.3.4CountryUnited States
    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 nameBicifadine Hydrochloride Sustained Release
    D.3.2Product code Bicifadine HCl SR
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNBicifadine
    D.3.9.1CAS number 66504-75-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic neuropathic pain in patients with diabetic peripheral neuropathy
    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 assess the safety of bicifadine SR in adult outpatients treated for chronic neuropathic pain associated with DPN for 52 weeks
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to be eligible for the study:
    1. Male or female, of any race, age 18 years or older.
    2. Diagnosis of Type-I (insulin dependent) or Type-II (non-insulin dependent) diabetes mellitus.
    3. Evidence of stable glucose levels over the three months prior to study entry, as documented by a written statement from the subject that their daily glucose levels have been stable and within normal limits, or, if outside normal limits that their diary shows stable values that are acceptable to the Principal Investigator at the site. Alternatively, a written statement from a physician or past laboratory values over the three month period prior to enrollment may be used to demonstrate stable glucose values.
    4. Evidence of chronic bilateral pain due to diabetic neuropathy, which is defined as pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk deep tendon reflexes.
    5. Presence of pain due to chronic diabetic neuropathy for at least 6 months prior to enrollment in Protocol B07-001.
    6. Must have completed all visits of Protocol XTL B07-001 or 12 weeks of treatment at the target dose.
    7. The primary pain location must be in the feet.
    8. For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectable, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study.
    9. Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    10. Subject must give written informed consent to participate. There must be evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent procedures of the study prior to performing any study procedures.
    E.4Principal exclusion criteria
    The presence of any of the following conditions will exclude a subject:
    1. Early discontinuation, for any reason, from Protocol XTL B07-001
    2. Presence of other pain that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy such as peripheral vascular disease (ischemic pain), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation), skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis, fibromyalgia)
    3. Symptoms of other painful conditions associated with diabetes such as thoracic radiculopathy or lumbar radiculopathy that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy
    4. Presence of amputations other than toe amputations
    5. History of lack of adequate therapeutic analgesic response to bicifadine, duloxetine or tricyclic antidepressants
    6. History of any clinically significant psychiatric or other neurological disorder other than diabetic neuropathy, headache, or migraine headache
    7. Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g., Alzheimer’s disease or schizophrenia or other psychosis), that in the investigator’s opinion may affect efficacy or safety assessments or may compromise subject safety during the trial
    8. History (within the last 10 years) of any seizure disorder or epilepsy
    9. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within the last 10 years
    10. Current evidence of clinically important diseases of gastrointestinal, hematopoietic, renal, respiratory, or cardiovascular systems; urinary retention; or glaucoma
    11. Female subjects who are pregnant and/or breastfeeding or have a positive serum pregnancy test at Visit 1
    12. History of known alcohol or narcotic substance abuse within 2 years prior enrollment in XTL B07-001
    13. History of any chronic illness other than diabetes that may interfere with or contraindicate participation in the study, as determined by the investigator
    14. A body mass index (BMI) of greater than 40
    15. Clinically relevant illness within the 30 days prior to the Baseline Visit that may interfere with the subject’s ability to complete the study
    16. Any subject considering or scheduled to undergo any major surgical procedure during the study period
    E.5 End points
    E.5.1Primary end point(s)
    Safety assessments using the following measures: Adverse events, concomitant therapy taken during the study, standard clinical laboratory tests and haemoglobin A1C, vital signs, physical examinations and 12-lead ECG with calculated QTc.
    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 No
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 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
    Last visit of the last patient undergoing the trial
    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 months11
    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 months11
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    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 90
    F.4.2.2In the whole clinical trial 240
    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)
    Subjects who discontinue this study for any reason or who complete this study will be referred to their physician and treated in accordance with the usual standards and practices of that physician and the institution (if any).
    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 Decision2008-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-12-10
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