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    Summary
    EudraCT Number:2011-002178-22
    Sponsor's Protocol Code Number:11-AVR-130
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-25
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-002178-22
    A.3Full title of the trial
    A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Double-blind, Randomized, Placebo-controlled, Four-arm, Multicenter, Dose-finding Study to Assess the Safety and Efficacy of Three Dose Levels of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Central Neuropathic Pain in Patients with Multiple Sclerosis
    A.4.1Sponsor's protocol code number11-AVR-130
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01324232
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAvanir Pharmaceuticals, 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 supportAvanir Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAvanir Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address20 Enterprise, Suite 200
    B.5.3.2Town/ cityAliso Viejo
    B.5.3.3Post codeCA 92656
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 949-268-1167
    B.5.5Fax number+1 949-268-1168
    B.5.6E-mailstudy11AVR130@avanir.com
    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 nameDextromethorphan/Quinidine
    D.3.2Product code AVP-923
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNDEXTROMETHORPHAN HYDROBROMIDE
    D.3.9.1CAS number 125-69-9
    D.3.9.2Current sponsor code11-AVR-130
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB01645MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQuinidine Sulfate
    D.3.9.2Current sponsor code11-AVR-130
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 nameDextromethorphan/Quinidine
    D.3.2Product code AVP-923
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNDEXTROMETHORPHAN HYDROBROMIDE
    D.3.9.1CAS number 125-69-9
    D.3.9.2Current sponsor code11-AVR-130
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB01645MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQuinidine Sulfate
    D.3.9.2Current sponsor code11-AVR-130
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 nameDextromethorphan/Quinidine
    D.3.2Product code AVP-923
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNDEXTROMETHORPHAN HYDROBROMIDE
    D.3.9.1CAS number 125-69-9
    D.3.9.2Current sponsor code11-AVR-130
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB01645MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNQuinidine Sulfate
    D.3.9.2Current sponsor code11-AVR-130
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Central Neuropathic Pain in Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Central Neuropathic Pain in Multiple Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the study are to evaluate the safety, tolerability, and efficacy of 3 doses of AVP-923 capsules containing either 45 mg DM and 10 mg Q (AVP-923-45) or 30 mg DM 10 mg Q (AVP-923-30) or 20 mg DM and 10 mg Q (AVP-923-20) compared to placebo, for the treatment of central neuropathic pain in a population of patients with multiple sclerosis (MS) over a 12-week period.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males and females 18 to 85 years of age, inclusive.
    2.The patient has a diagnosis of RRMS or SPMS (MS must be diagnosed according to the McDonald criteria).
    3.The patient has a clinical history and clinical relevant symptoms of central neuropathic pain (dysesthetic pain) secondary to MS for at least 3 months prior to screening and expected to remain otherwise stable during the study. Patients meeting the criterion for central neuropathic pain and experiencing concomitant non-central neuropathic pain (e.g., back pain, headache, chronic visceral pain, musculoskeletal postural pain, trigeminal neuralgia or Lhermitte's sign) are allowed to participate in the study as long as central neuopathic pain of the extremities is the predominant type of pain.
    4.Mean PRS score at Baseline is more or equal to 4.
    5.The patient has not experienced an MS relapse within the previous 30 days.
    6.The patient has stable hematologic, hepatic, and renal function, with no clinically significant symptoms, and no clinically significant clinical laboratory abnormalities.
    7.The patient has a negative urine drug screening panel result (including amphetamines, barbiturates, cocaine metabolite, opiates and THC [cannabinoids]).
    8.The patient has an ECG (obtained within 4 weeks prior to entry and evaluated by a certified cardiologist) with no evidence of clinically significant abnormality and with no evidence of: complete heart block, ventricular tachycardia, or frequent unifocal ventricular ectopic beats (>5 per minute).
    9.If female, must not be pregnant, breast-feeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test at screening and at baseline.
    10.If female, must have been practicing a medically-acceptable method of birth control for at least 1 month prior to randomization (oral contraceptive tablets, hormonal implant device, hormone patch, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, tubal ligation, or abstinence) or be surgically sterile or post-menopausal.
    11.Patients currently receiving an MS disease-modifying therapy ([MS DMT] eg, interferon beta, glatiramer, natalizumab, fingolimod) are eligible provided they have been on a stable dose of these medications for at least 2 months prior to randomization.
    12.Patients currently receiving fampridine/dalfampridine should be on a stable dose for at least 2 months prior to randomization.
    13.Patients currently taking SSRIs (selective serotonin reuptake inhibitors) for the treatment of major depression for at least 3 months on a stable dose prior to randomization are eligible, provided the SSRI dose remains unchanged during the study.
    14.Patient must not show current symptoms of a depressive disorder.
    15.Patient must have a score of ≤19 in the BDI-II at screening and at baseline.
    16.Patient must be willing to not take any prohibited medications during the study.
    17.Patient signed and received a copy of an ICF after the nature and risks of study participation had been fully explained to them
    E.4Principal exclusion criteria
    1.Patient (or caregiver) is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
    2.Other types of neuropathic pain unrelated to MS (e.g., DPN pain).
    3.Patients with myasthenia gravis.
    4.Any personal history of complete heart block, QTc prolongation, or torsades de pointes.
    5.Any family history of congenital QT interval prolongation syndrome.
    6.Patients with known sensitivity to DM, Q, or opiate drugs (codeine, etc.).
    7.Patients with known sensitivity to ibuprofen.
    8.Patients experiencing an MS relapse within the previous 30 days.
    9.Patients who have been taking disallowed concomitant medications within 2 weeks prior to Baseline (Day 1).
    10.Patients currently using, or have been using marijuana or dronabinol within 2 weeks prior to Baseline (Day 1).
    11.Patients with a current or prior history of major psychiatric disorder. Exclusionary psychiatric diagnoses, to be determined by chart review and patient interview, include the following Axis I disorders (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV] criteria): (i) current symptoms of major depression; (ii) bipolar disorder; (iii) schizophrenia or other psychotic disorder; (iv) somatoform disorders; and the Axis II disorder of borderline personality.
    12.Patients with co-existent major systemic diseases that would interfere with interpretation of the results of the study (eg, malignancy [exept skin basal-cell carcinoma], poorly controlled diabetes, poorly controlled hypertension, ischemic cardiac disease, dilated cardiomyopathy, or valvular heart disease).
    13.Patients who are currently participating in, or who have participated in other clinical study within the past 30 days.
    14.Patients with severe and/or unstable pulmonary disease.
    15.Patients who have received DM co-administered with Q within the previous 3 months.
    16.Patients with symptomatic hypotension, history of postural syncope or any history of unexplained synope (evaluated on a case-by case basic).
    17. Evidence of uncontrolled diabetes based on HbA1c below 53 mmol/ mol (> 7.0%)
    18. Patients with a histrory of substance and/or alcohol abuse within the past 2 years.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the 11 point (0-10) PRS obtained from daily patient diaries.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be carried out using an analysis of covariance (ANCOVA) model with the PRS change from baseline to Days 57-84 as the dependent variable, treatment group as a factor, and the baseline PRS score as a covariate. The primary analysis will compare the AVP 923-45 group to the placebo group.
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include the FSS, MSIS-29, PSQI, MSNQ, SDMT, BDI-II, MAS, NRS and PGIC scores
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis of the secondary efficacy variables will be based on the change from baseline to the Day 85 visit using an analysis of covariance (ANCOVA) model with treatment group as factors and the baseline scores as covariates.
    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 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 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 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.8.2.4Number of treatment arms in the trial4
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Bulgaria
    Czech Republic
    Germany
    Poland
    Spain
    United Kingdom
    United States
    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
    End of the trial is LVLS
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 400
    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)
    After the patient has completed his/her participation in the study, the treating physician will prescribe the appropriate available therapy to continue treatment
    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 Decision2012-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-30
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