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    The EU Clinical Trials Register currently displays   43628   clinical trials with a EudraCT protocol, of which   7211   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:2015-004550-18
    Sponsor's Protocol Code Number:TV48125-CNS-30051
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-02
    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 - PEI
    A.2EudraCT number2015-004550-18
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel-Group Study Evaluating the Long Term Safety, Tolerability, and Efficacy of Subcutaneous Administration of TEV 48125 for the Preventive Treatment of Migraine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial of TEV-48125 to evaluate long term safety, tolerability and efficacy for the Preventive Treatment of Migraine
    A.4.1Sponsor's protocol code numberTV48125-CNS-30051
    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 SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Str. 3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.6E-mailInfo.era-clinical@teva.de
    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 nameTEV-48125
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfremanezumab
    D.3.9.1CAS number 1655501-53-3
    D.3.9.2Current sponsor codeTEV 48125
    D.3.9.3Other descriptive nameTEV 48125
    D.3.9.4EV Substance CodeSUB181665
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic and Chronic Migraine
    E.1.1.1Medical condition in easily understood language
    Episodic and Chronic Migraine
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10066636
    E.1.2Term Chronic migraine
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10027602
    E.1.2Term Migraine headache
    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 primary objective of the study is to evaluate the long-term safety and tolerability of sc TEV 48125 in the preventive treatment of migraine.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients Rolling Over from the Pivotal Efficacy Studies: Patients may be included in this study only if they meet all of the following criteria:
    a. Patient signs and dates the informed consent document.
    b. Patient must have completed the pivotal efficacy study without major protocol violations.
    c. Patients may continue with a stable dose/regimen of the preventive medication they were taking during the pivotal efficacy studies.
    d. Patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.

    Patients Not Rolling Over from the Pivotal Efficacy Studies: Patients may be included in this study only if they meet all of the following criteria:
    a. Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age.
    b. Patient signs and dates the informed consent document.
    c. Patient has history of migraine (according to ICHD-3 criteria [Classification Committee of the IHS, 2013]) or clinical judgment suggests a migraine diagnosis (not better accounted for by another ICHD-3 diagnosis) for ≥12 months prior to screening.
    d. Patient fulfills the following criteria for EM or CM with prospectively collected baseline information during the 28-day run-in period:
    -Patients with EM:
    ○ headache occurring on ≥4 and ≤14 days
    ○ on ≥4 days, fulfilling any of the following:
     ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura
     ICHD-3 criteria B and C for 1.2 Migraine with aura
     Probable migraine (a migraine subtype where only 1 migraine criterion is missing)
     The patient used a triptan or ergot derivative to treat an established headache.
    - Patients with CM:
    ○ headache occurring on ≥15 days
    ○ on ≥8 days, fulfilling any of the following:
     ICHD-3 diagnostic criteria C and D for 1.1 Migraine without aura
     ICHD-3 criteria B and C for 1.2 Migraine with aura
     Probable migraine (a migraine subtype where only 1 migraine criterion is missing)
     The patient used a triptan or ergot derivative to treat an established headache.
    e. Not using preventive medications (ie, at least 5 half-lives have passed since last use) or using no more than 1 preventive medication for migraine or other medical conditions (eg, propranolol used for hypertension) if the dose and regimen have been stable for at least 2 months prior to beginning the 28-day run-in period.
    f. Body mass index of 17.5 to 37.5 kg/m2 and a total body weight between 45 and 120 kg, inclusive
    g. All patients must be of nonchildbearing potential, defined as:
    - women surgically sterile by documented complete hysterectomy, bilateral oophorectomy, or bitubal ligations or confirmed to be postmenopausal (at least 1 year since last menses and follicle-stimulating hormone above 35 U/L)
    - men surgically sterile by documented vasectomy
    or
    if of childbearing potential, patients must meet any of the following criteria:
    - Patients must simultaneously use 2 forms of highly effective contraception methods with their partners during the entire study period and for 7.5 months after the last dose of study drug.
    - Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods),
    declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception.
    h. Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).
    i. The patient demonstrated compliance with the electronic headache diary during the run-in period by entry of headache data on a minimum of 24 out of 28 days (~85% diary compliance).
    j. The patient is in good health as determined by a medical and psychiatric history, medical examination, 12-lead ECG, serum chemistry, hematology, coagulation, and urinalysis.
    k. The patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol.

    Patients Rolling Over from the Pivotal Efficacy Studies for ADA Assessment Only: Patients may be included in this study if they sign and date the informed consent document.
    E.4Principal exclusion criteria
    Patients Rolling Over from the Pivotal Efficacy Studies: Patients will be excluded from participating in this study if they meet any of the following criteria:
    a. Any finding that, in the judgment of the investigator, is clinically significantly abnormal, including hematology values, serum chemistry, coagulation tests, or urinalysis (abnormal tests may be repeated for confirmation)
    b. Pregnant or nursing females
    c. Any finding in the baseline 12-lead ECG considered clinically significant in the judgment of the investigator
    d. Compliance with daily diary entry lower than 75% at the last month of the double-blind treatment period of the pivotal efficacy study

    Patients Not Rolling Over from the Pivotal Efficacy Studies: Patients will be excluded from participating in this study if they meet any of the following criteria:
    a. Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator
    b. Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years
    c. History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events) such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
    d. Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
    e. Past or current history of cancer in the past 5 years, except for appropriately treated nonmelanoma skin carcinoma
    f. Pregnant or nursing females
    g. History of hypersensitivity reactions to injected proteins, including monoclonal antibodies
    h. Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months before study drug administration or 5 half-lives, whichever is longer
    I. Any finding in the baseline 12 lead ECG considered clinically significant in the judgment of the investigator
    j. Any finding that, in the judgment of the investigator, is a clinically significant abnormality, including serum chemistry, hematology, coagulation, and urinalysis test values (abnormal tests may be repeated for confirmation)
    k. Hepatic enzymes (alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) >1.5 × the upper limit of the normal range (ULN) after confirmation in a repeat test or suspected hepatocellular damage that fulfills criteria for Hy’s law at screening
    l. Serum creatinine >1.5 × the ULN, clinically significant proteinuria, or evidence of renal disease at screening
    m. History of alcohol or drug abuse during the past 2 years, or alcohol or drug dependence during the past 5 years
    n. The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons:
    - mentally or legally incapacitated or unable to give consent for any reason
    - in custody due to an administrative or a legal decision, under guardianship, or institutionalized
    - unable to be contacted in case of emergency
    - has any other condition, which, in the opinion of the investigator, makes the patient inappropriate for inclusion in the study
    o. Patient is a study center or sponsor employee who is directly involved in the study or the relative of such an employee.

    Patients Rolling Over from the Pivotal Efficacy Studies for ADA Assessment Only: Not applicable.
    E.5 End points
    E.5.1Primary end point(s)
    • occurrence of adverse events throughout the study
    • changes from baseline in clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis) test results
    • abnormal standard 12-lead electrocardiogram (ECG) findings
    • changes from baseline in vital signs (pulse, systolic and diastolic blood pressure, body temperature, and respiratory rate) measurements
    • abnormal physical examination findings
    • abnormal local injection site tolerability findings (ie, erythema, induration, and ecchymosis) and occurrence of injection site pain
    • suicidal ideation and behavior as suggested by the electronic Columbia-Suicide Severity Rating Scale (eC-SSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.5.2Secondary end point(s)
    There are no secondary efficacy endpoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) 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 No
    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 trial3
    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 EEA23
    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
    Canada
    Czech Republic
    Germany
    Israel
    Japan
    Poland
    Russian Federation
    Spain
    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
    The end of the study is defined as the date the last patient attends the follow-up visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 1692
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 2016-05-02. 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 state71
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 271
    F.4.2.2In the whole clinical trial 1842
    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)
    No further treatment and medical supervision of the patients after the end of the clinical trial is planned for the above clinical trial. Those patients who complete the study will receive standard of care from their doctors.
    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 Decision2016-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
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