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    Summary
    EudraCT Number:2004-004999-36
    Sponsor's Protocol Code Number:BCBe/04/FRO-CLU/001
    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:2006-08-18
    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 - BfArM
    A.2EudraCT number2004-004999-36
    A.3Full title of the trial
    Effects of Frovatriptan as Prophylactic Treatment of Cluster Headache, a Multi-Center, Placebo Controlled, Randomized, Double-Blind Prospective Phase III Parallel-Group Trial Comparing Frovatriptan with Placebo
    A.4.1Sponsor's protocol code numberBCBe/04/FRO-CLU/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 SponsorBerlin-Chemie AG
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Allegro 2.5 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBerlin Chemie AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameFrovatriptan
    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 INNFrovatriptan
    D.3.9.1CAS number 158747-02-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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.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
    Episodic cluster headache
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10009698
    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 effect of 5 mg frovatriptan given once daily on the frequency of cluster headache attacks as compared to placebo.
    E.2.2Secondary objectives of the trial
    Secondary objective(s): To assess the effect of frovatriptan as compared to placebo on: (1) the frequency of cluster headache attacks during the follow-up period; (2) the pain intensity of the cluster headache attacks; (3) the duration of the cluster headache attacks; (4) the associated autonomic symptoms of the cluster headache attacks; (5) the frequency of used oxygen for symptomatic treatment of the cluster headache attacks; (6) the use of additional drug treatment of the cluster headache attacks; (7) the quality of life as documented in the SF-36 questionnaire; (8) the global evaluation of therapy; (9) the therapy satisfaction
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria that are to be determined at visit 1, day –7 (Run-in), to be considered eligible for study entry:
    1. Written informed consent
    2. Age between 18 and 65 years
    3. Known episodic cluster headache, diagnosed according to the criteria of the International Headache Society (IHS)11; duration of an individual attack lasting between 15 minutes and 180 minutes, localisation strictly unilateral, cluster headache intensity at least moderate
    4. At least second episode of cluster headache
    5. Duration since onset of first attack of the current episode at least one week
    6. Expected duration of cluster episode at least 6 weeks after start of screening
    7. Response to oxygen inhalation (relevant change in headache severity)

    Additionally, the patient has to meet the following inclusion criterion that is to be determined at visit 2, day 0 (baseline, randomisation):
    Attack frequency between one attack every two days and eight attacks per day
    E.4Principal exclusion criteria
    Patients must not meet any of the following exclusion criteria to be considered eligible for study entry:
    1. Any form of cluster headache other than episodic cluster headache
    2. History of alcohol and/or drug and/or substance abuse
    3. Progressive neurologic disease, i.e. cerebral tumours or structural brain damage caused by a birth defect, trauma, or infection
    4. History of myocardial infarction, coronary vasospasm (e.g., Prinzmetal’s angina)
    5. History or signs or symptoms of ischaemic heart disease
    6. Stage II hypertension (SBP ³ 160 mmHg or DBP ³ 100 mmHg) or uncontrolled stage I hypertension (according to JNC)
    7. History of peripheral vascular disease
    8. Condition following apoplexy or history of transient ischaemic attack
    9. Severe hepatic insufficiency (Child-Pugh C)
    10. Severe renal insufficiency
    11. Congenital disorders like Galactosaemia, Lactase deficiency or Glucose-Galactose malabsorption
    12. Clinically significant psychiatric diseases
    13. Known hypersensitivity to triptans or any of the ingredients of the study medication
    14. Previous prophylactic treatment of cluster headache with frovatriptan within the last 30 days
    15. Previous treatment within 6 months prior to the beginning of the study or concomitant treatment with substances which may decrease the efficacy of the test substance(s) or may lead to drug interactions, for example
    a) antipsychotic drugs
    b) antidepressant drugs
    16. Prophylactic and concomitant treatment of cluster headache e.g., verapamil, lithium, valproic acid (divalproex sodium), topiramate, gabapentin, lamotrigine, melatonin changed within one month prior to Visit 1 or changed during the study
    17. Prophylactic and concomitant treatment with corticosteroids, civamide or botulinum toxin A
    18. Previous treatment within 24 hours prior to the beginning of the study or concomitant treatment with other triptans (including treatment of acute attacks with subcutaneous sumatriptan)
    19. Previous treatment within 24 hours prior to the beginning of the study or concomitant treatment with ergotamine, ergotamine derivatives (including methysergide) or other 5-hydroxytryptamine(5-HT1)-receptor agonists
    20. Concomitant anaesthesia of the greater optical nerve
    21. Concomitant treatment with herbal remedies containing St. John’s Wort
    22. Women of childbearing potential without adequate contraception; Medically acceptable methods are those with a failure rate less than 1% per year, such as contraceptive implant, contraceptive injection, some intrauterine devices (IUD), or combined oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study
    23. Current participation in another clinical study or patients who have received an investigational drug within 30 days prior to entering the study
    24. Patients who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial
    25. Known HIV, HBV or HCV infection
    E.5 End points
    E.5.1Primary end point(s)
    Mean cluster headache attack frequency per week during the two weeks treatment period.

    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 Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    See protocol section 9.6: The end of the study is defined as the last visit of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months11
    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 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    See Protocol section 9.4: "No provision of any additional care is arranged for the patients once their participation in the trial has ended. The subsequent therapy of cluster headache shall be discussed with the patient and, if needed, with the patient’s general practitioner. The patient will be treated by his medical doctor who had been in charge before this study in a way that should not differ from what is normally expected."
    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 Decision2006-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-12-31
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