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    Summary
    EudraCT Number:2010-024137-22
    Sponsor's Protocol Code Number:D4130C00004
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-15
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-024137-22
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy
    A.4.1Sponsor's protocol code numberD4130C00004
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 nameTC-5214 (S-mecamylamine)
    D.3.2Product code TC-5214 (S-mecamylamine)
    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 107596-30-5
    D.3.9.2Current sponsor codeTC-5214-23
    D.3.9.3Other descriptive nameS(+)- Mecamylamine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.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 nameTC-5214 (S-mecamylamine)
    D.3.2Product code TC-5214 (S-mecamylamine)
    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 107596-30-5
    D.3.9.2Current sponsor codeTC-5214-23
    D.3.9.3Other descriptive nameS(+)-Mecamylamine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 3
    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 nameTC-5214 (S-mecamylamine)
    D.3.2Product code TC-5214 (S-mecamylamine)
    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 107596-30-5
    D.3.9.2Current sponsor codeTC-5214-23
    D.3.9.3Other descriptive nameS(+)-Mecamylamine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    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
    Adjunct treatment to an antidepressant in patients with Major Depressive Disorder who exhibit an inadequate response to antidepressant therapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of TC-5214 compared with placebo as an adjunct to antidepressant (selective serotonin reuptake inhibitor SSRI]/serotonin/norepinephrine reuptake inhibitor [SNRI]) therapy in patients with major depressive disorder (MDD) who exhibit an inadequate response to antidepressant therapy, as assessed by change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from randomization (Week 8) to end of treatment (Week 16).

    Safety and tolerability objectives:
    To evaluate the safety and tolerability of TC-5214 and placebo as an adjunct to an antidepressant (SSRI/SNRI) in patients with MDD who exhibit an inadequate response to antidepressant therapy.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of TC-5214 compared with placebo as an adjunct to an antidepressant (SSRI/SNRI) in patients with MDD who exhibit an inadequate
    response to antidepressant therapy as assessed by 1) depressive symptoms, clinical
    global outcome regarding severity and improvement, and anxiety, 2) by patient-reported outcomes (PROs) regarding functional impairment, overall quality of life, severity of depressive symptoms, and irritability symptoms.
    • To investigate pharmacokinetic (PK) properties of TC-5214 in patients with MDD
    using a population PK analysis methodology. These results will be reported
    separately from the primary and other secondary objectives.
    • Change in overall quality of life and satisfaction from randomization (Week 8) to
    end of treatment (Week 16) in Q-LES-Q-SF, items 15 and 16
    • Change in health-related quality of life as measured by the EuroQol VAS and
    5 dimensions (EQ-5D) from randomization (Week 8) to end of treatment (Week 16)
    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 Research appendix D
    E.3Principal inclusion criteria
    1. Provision of signed and dated informed consent before initiation of any study-related procedures.
    2. Patients must provide acceptable proof of identity documentation to confirm initials and date of birth.
    3. Male or female patients 18 to 65 years of age:
    · Male patients: Male patients who are sexually active must use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 12 weeks after their last dose.
    · Women of childbearing potential: Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test and confirmed (by the investigator) use of a highly effective form of birth control for 3 months before enrollment and until 3 months after their last dose of IP. The following methods of highly effective birth
    control include the birth control option plus the use of a condom by the male sexual partner: vasectomized sexual partner, tubal occlusion, intrauterine device (IUD [copper banded coils only]), intrauterine system (eg, Mirena), Depo-Provera, implants (Implanon, Norplant), normal and low dose combined oral pills, ethinylestradiol transdermal system (Evra Patch), and intravaginal device (NuvaRing). Highly effective birth control can also include true sexual abstinence (starting at the screening visit and through completion of the study). The investigator will assess the method of birth control and compliance at each study visit.
    · Women of non-child-bearing potential. Women of non child-bearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but excluding
    bilateral tubal occlusion) or who are postmenopausal. Women will be considered postmenopausal if they are amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
    · Women under 50 years old would be considered post menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post-menopausal range.
    · Women over 50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment.
    4. Primary clinical diagnosis meeting criteria from the DSM-IV-TR:
    · 296.2x Major Depressive Disorder (MDD), Single Episode, Unspecified or
    · 296.3x Major Depressive Disorder (MDD), Recurrent, Unspecified
    as confirmed via the Mini-International Neuropsychiatric Interview (MINI) version 6.0 diagnostic scale.
    5. History during current depressive episode of an inadequate response to no more than one antidepressant (SSRI/SNRI) as assessed by a review of the patients history (ATHF). Patients who are not currently receiving treatment with antidepressant drugs during this current depressive episode are allowed.
    6. Documented HAMD-17 as follows:
    - Screening (Visit 1) and open-label baseline (Visit 2): Clinician-rated total score ≥20.
    - Randomization (Week 8/Visit 6): Clinician rated ≥16 total score and a <50% reduction in total score compared to open-label baseline (Visit 2).
    7. Have a HAMD-17 score ≥2 on item 1 (depressed mood) at screening (Visit 1) and open-label baseline (Visit 2).
    8. Documented CGI-S as follows:
    - Screening (Visit 1): CGI -S score ≥4
    - Randomization (Week 8/Visit 6): CGI-S score ≥4
    9. Be able to understand and comply with the requirements of the study, as judged by the investigator.
    10. Outpatient status at enrollment and randomization (Week 8)
    For inclusion into the optional genetic research portion of the study, the patient must fulfill the following additional criterion:
    11. Have provided written informed consent for genetic sampling before initiation of any genetic sampling.
    If a patient declines to participate in the optional genetic portion of the study, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this CSP, so long as they consent.
    E.4Principal exclusion criteria
    1. Patients with: a) lifetime history of bipolar disorder or psychotic disorder; MDD with psychotic features is excluded; b) current (within 12 months before open-label baseline [Visit 2]) manic episode, post-traumatic stress disorder as assessed by the MINI 6.0 and confirmed by the investigator; c) current (within 12 months before
    open-label baseline [Visit 2]) generalized anxiety disorder, panic disorder, obsessive compulsive disorder or social anxiety disorder as assessed by the MINI 6.0 and considered by the investigator to be primary (causing a higher degree of distress or impairment than MDD).
    2. Patients with a diagnosis of DSM-IV-TR Axis II disorder which has a major impact on the patient’s current psychiatric status.
    3. Patients whose current episode of depression started less than 8 weeks before screening.
    4. History of hypersensitivity or intolerance to drugs with a similar chemical structure or class to TC-5214.
    5. Substance or alcohol abuse or dependence within 6 months prior to enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined in DSM-IV-TR criteria. Patients with a positive urine toxicology screen will be excluded, with the exception of patients testing positive for cannabinoids (see Section 6.4.5.3). Patients can be re-tested if the initial urine toxicology screen is positive, but should be excluded if the results are still positive at the second test.
    6. Subjects with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide, or considered at risk for suicide or homicide during the study. Also patients who have a HAMD-17 item 3 score of ≥3.
    7. Presence of renal insufficiency as evidenced by creatinine clearance of ≤50 mL/min (measured using Cockroft-Gault equation).
    8. Any significant unstable hepatic (including Hepatitis B [HBV] and Hepatitis C [HCV]), renal, pulmonary, cardiovascular (including uncontrolled hypertension defined as higher than 160/100 mm Hg), ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the patient at greater risk during study participation.
    9. Positive test results for human immunodeficiency virus (HIV) antibody.
    10. History of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product (eg, malabsorption syndrome, severe liver disease, history of gastric bypass, gastrointestinal motility disorder including chronic constipation, pyloric stenosis, or history or ileus), as judged by the investigator.
    11. Patients on thyroid medication unless at a stable dose for ≥3 months; thyroid level must be within normal range.
    12. A diagnosis of cancer (except basal or squamous cell skin carcinoma), unless in remission for at least 5 years.
    13. Any other severe progressive or uncontrolled medical condition, or chronic medical illness (eg. fibromyalgia, chronic pain conditions, obstructive sleep apnea).
    14. Known presence of raised intraocular pressure or history of narrow-angle glaucoma.
    15. Evidence of uncontrolled diabetes mellitus as judged by the investigator or exhibited by hemoglobin A1c (HbA1c) >8%.
    16. Alanine aminotransferase (ALT) or asparate aminotransferase (AST) ≥3.0 times the upper limit of normal (ULN) and total bilirubin 1.2 times the ULN (unless documented Gilbert’s syndrome).
    17. History of severe medication allergy/hypersensitivity or ongoing medication allergy/hypersensitivity other than seasonal allergies, as judged by the investigator.
    18. History of stroke or transient ischemic attack.
    19. Myocardial infarction within 180 days before screening (Visit 1).
    20. History of seizures or seizure disorder (single infant febrile seizure with full recovery is acceptable).
    21. History of head trauma, including closed head injury, in which loss of consciousness occurred.
    22. Receipt of electroconvulsive therapy (ECT) within the last 2 years.
    23. Use of prohibited treatments (refer to Table 4 and Table 5for additional information on prohibited medications).
    24. Patients who, in the investigator’s opinion, will require any form of psychotherapy during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to study start.
    25. Pregnancy or lactation.
    26. Clinically significant deviation from the reference range in clinical laboratory test results at enrollment, as judged by the investigator.
    27. Donation of plasma or blood products within 14 days of Day 1. Blood or plasma donation will not be allowed from the screening visit through completion of the study (patients who completed double-blind treatment and 1-2 week follow-up are considered as completing the study).
    28. History of orthostatic hypotension.
    29. Clinically significant electrocardiogram (ECG) abnormalities as determined by the investigator and/or central ECG reader.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable: Change in the MADRS total score from randomization (week8) to end of treatment (week16)
    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 Yes
    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 Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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 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) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-02-15. Yes
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 795
    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 Decision2011-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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