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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2007-003638-40
    Sponsor's Protocol Code Number:XTL B07-001
    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:2007-10-02
    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 number2007-003638-40
    A.3Full title of the trial
    A Double-blind, Randomized, Placebo-controlled, Parallel, Multicenter Study of the Safety and Efficacy of Two Dosages of Bicifadine SR in Adult Outpatients with Chronic Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
    A.4.1Sponsor's protocol code numberXTL B07-001
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    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
    1. To compare the efficacy of 2 dosages (600 mg/day and 1200 mg/day) of bicifadine sustained release (SR) with placebo in reduction of chronic neuropathic pain (measured by a daily rating of pain intensity) associated with diabetic peripheral neuropathy (DPN) in adult outpatients
    2. To compare the tolerability of 2 dosages (600 mg/day and 1200 mg/day) of bicifadine SR with placebo in adult outpatients treated for chronic neuropathic pain associated with DPN
    E.2.2Secondary objectives of the trial
    1. To compare the efficacy of treatment with 2 dosages of bicifadine SR with placebo on the following secondary efficacy measures:
    • proportion of responders, defined as ≥30% reduction from Baseline to Week 14 in weekly mean of daily ratings of pain intensity
    • change from Baseline in scores on the following pain-related measures:
    - Brief Pain Inventory score
    - Clinical Global Impression of Improvement rating
    - Patient Global Impression of Change rating
    - Short Form McGill Pain Questionnaire Form X scores
    • the amount of rescue medication used for pain
    • change from Baseline in depression scores on the Beck Depression Inventory II
    2. To compare the efficacy of treatment with 2 dosages of bicifadine SR with placebo on the following health outcome measures:
    • change from Baseline in daily functioning as measured by the interference portion of the BPI
    • change from Baseline in quality of life as measured by the Short Form-36 version 2 Health Survey (SF-36v2)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol code:XTL B07-002
    Protocol Title: An Open-label 52-Week Safety Study of Bicifadine SR (Sustained Release) in Adult Outpatients with Chronic Neuropathic Pain associated with Diabetic Peripheral Neuropathy.
    Version of July 20, 2007
    Objective: To assess the safety of bicifadine SR in adult outpatients treated for chronic neuropathic pain associated with diabetic peripheral neuropathy for 52 weeks.
    E.3Principal inclusion criteria
    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. Hemoglobin A1C of ≤11%
    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. Neuropathy diagnosis confirmed by a score of ≥3 on the Michigan Neuropathy Screening Instrument (MNSI) Part B only.
    6. Presence of pain due to chronic diabetic neuropathy for at least 6 months prior to the initial screening visit
    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
    1. 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)
    2. Symptoms of other painful conditions such as thoracic radiculopathy or lumbar radiculopathy that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy
    3. Presence of amputations other than toe amputations
    4. History of lack of analgesic response to an adequate trial of duloxetine, venlafaxine, or tricyclic antidepressants (TCAs)
    5. Score of >20 on the BDI
    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. Use of the following medications (which could affect symptoms of pain due to chronic diabetic neuropathy) during the study: TCAs, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, other AEDs (such as carbamazepine), baclofen, mexiletine, capsaicin, tramadol, opioids, or other analgesics (except for acetaminophen up to 3 g/day and prophylactic aspirin up to 325 mg/day). All of these excluded medications require a washout period of appropriate length (according to the investigator) before the Screening II Visit.
    11. Current evidence of clinically important diseases of gastrointestinal, hematopoietic, renal, respiratory, or cardiovascular systems; urinary retention; or glaucoma
    12. Female subjects who are pregnant and/or breastfeeding or have a positive serum pregnancy test at the Screening or Baseline Visits
    13. Positive urine drug screen for amphetamines, barbiturates, marijuana metabolites, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine (PCP), or propoxyphene. However, a positive urine drug screen for benzodiazepines will not necessarily exclude the subject.
    14. History of known alcohol or narcotic substance abuse within 2 years prior to the initial screening visit
    15. History of any chronic illness other than diabetes that may interfere with or contraindicate participation in the study, as determined by the investigator
    16. A body mass index (BMI) of greater than 40
    17. Clinically-relevant illness within the 30 days prior to the initial screening visit that may interfere with the subject’s ability to complete the study
    18. Participated in a previous clinical study of bicifadine
    19. Any subject considering or scheduled to undergo any major surgical procedure during the study period
    20. Any subject who has taken any other investigational drug during the 30 days prior to the initial screening visit
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the PI-NRS, which is a 0-10 rating of average pain intensity over a 24-hour period. Subjects make these ratings each day in an electronic diary. The primary efficacy variable is the change from Baseline to Week 14 in the weekly mean of the PI-NRS scores.
    Secondary efficacy measures of the BPI, SF-MPQ, and BDI are all analyzed as change scores from Baseline to Weeks 6, 10, and 14. CGI-I and PGIC scores are analyzed as raw scores at Weeks 6, 10, and 14. The health outcome efficacy measures are the interference portion of the BPI and total score on the SF-36v2, which are analyzed as change scores from Baseline to Weeks 6, 10, and 14. Use of rescue medication will be measured at Weeks 6, 10, and 14.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.4.1Number 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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 336
    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 completing all visits will be offered the opportunity to enroll in a 12-month, open-label safety study. Subjects who discontinue this study for any reason or who complete this study but choose not to enroll in the 12-month trial 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 Decision2008-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-12-18
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