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    Summary
    EudraCT Number:2007-006773-92
    Sponsor's Protocol Code Number:FARM6TT8SP
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-006773-92
    A.3Full title of the trial
    Sodium Valproate in the treatment of medication overuse headache: a controlled randomized clinical trial.
    A.3.2Name or abbreviated title of the trial where available
    SAMOHA
    A.4.1Sponsor's protocol code numberFARM6TT8SP
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorUNIVERSITA' DEGLI STUDI DI PERUGIA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 DEPAKIN
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Gastro-resistant capsule, hard
    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 INNValproic acid
    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 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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 Information not present in EudraCT
    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 nameValproic acid
    D.3.4Pharmaceutical form Gastro-resistant 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 INNValproic acid
    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 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 placeboGastro-resistant 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
    medication overuse headache
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10013753
    E.1.2Term Drug withdrawal headache
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10019231
    E.1.2Term Headaches
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the efficacy of a short-term (12-week) treatment with sodium valproate at the dosage of 800 mg/die compared with placebo in reducing the number of days with headache in patients with medication-overuse headache following a 6-day out-patient detoxification regimen.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of sodium valproate at the dosage of 800 mg/die on psychopathological disturbances complained by MOH patients compared with placebo using ad hoc scales and questionnaires. To determine treatment satisfaction in patients treated with sodium valproate as prophylactic agent compared with patients treated with placebo To investigate the safety and tolerability of sodium valproate at the dosage of 800 mg per day compared with placebo using various clinical endpoints in the preventive treatment of MOH after a detoxification regimen
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    FARMACOGENETICA: Versione:1 Data:2007/11/19 Titolo:SODIUM VALPROATE IN THE TREATMENT OF MEDICATION
    OVERUSE HEADACHE: A CONTROLLED RANDOMIZED TRIAL Obiettivi:The aim of our study is to analyze the genetic mechanisms influencing the response to sodium valproate therapy in a sample of patients affected by MHO.
    E.3Principal inclusion criteria
    - Subjects, both genders, aged 18-60 years (inclusive) at study entry - Subject, has an established history of episodic migraine without aura in the past; - Subject has an average of at least 15 days per month with headache during the last 3 months preceding the entry into the study; - Headache fulfils ICHD-IIR criteria for MOH (see Appendix 1); -If the medication overused is a simple analgesic the included subject must have used this symptomatic drug on > 15 days per month, for at least 3 months. If the medication overused is a triptan, or a combination of analgesic or a combination of acute medications, the included subject must have used the above drugs on > 10 days per month, for at least 3 months. (see Appendix 2); - Subject judged to be reliable and agreeable to keeping all appointments for clinic visits, tests, and procedures required by the protocol. - Subject, or their legal representatives, must have signed and dated the informed consent; - A female is eligible to enter and participate in this study if she is: a) non-childbearing potential i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal (> 1 year since last menstrual cycle ), had a documented tubal ligation or is surgically sterilized); b) childbearing potential, has a negative pregnancy test –urine (at screening), and agree to one of the following: 1. Complete abstinence from intercourse from 2 weeks prior to administration the investigational product, throughout the treatment period and for a minimum of one week after completion or premature discontinuation from investigational product. 2. Consistent and correct use of an acceptable method of birth control
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply: - Subject has taken a headache-prevention medication during the month preceding enrolment in the trial. - Known allergy, sensitivity or intolerance to study drugs and/or study drugs’ formulation ingredients; - Known allergic reactions to drugs; - Subject used prohibited concomitant therapy [other antiepileptics; barbiturates; antidepressants; some antibatterial drugs (Carbapenem, Panipenem, Meropenem, Imipenem and Erythromycin); anticoagulants; Neuroleptics; Zidovudine, Mefloquine, cytostatics, Cimetidine, Colestiramine, and chronic use of Acetyl-salicylic Acid and benzodiazepines]; - Subject has a history or suspicion of alcohol abuse or illicit drug use in the past 2 years; - Subject has a history of poor compliance with past drug therapies, or is felt to be at risk of non-compliance (for taking study medication or for completing the diary) as judged by the Investigator; - Subject is pregnant or breastfeeding female. For women with childbearing potential, absence of pregnancy must be confirmed by a pregnancy test at study entry; - Subject is female of childbearing potential without adequate contraception; - Subject with a past or present history of a serious illness, which as judged by the Investigator, may affect the outcome of this study. These diseases, in the six months prior the screening, include: liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), metabolic disturbances; - Clinically significant abnormalities in safety laboratory analysis at the Screening Visit. Particularly any liver function test (including ALT, AST and ALP) > 1.5 x upper limit normal (ULN) at the screening visit; - Subject is concurrently participating in another clinical study or investigational drug trial or has participated within the previous 30 days in an investigational drug study or is planning to participate in another drug or device study at any time during the study (screening through follow-up).
    E.5 End points
    E.5.1Primary end point(s)
    Change in the number of days with headache/month (decrease &#8805;50%) versus the baseline phase (4 weeks without preventive treatment. Responders will be defined as those having a &#8805; 50% reduction in headache days/month.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 concerned12
    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 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
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state476
    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 Decision2008-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
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