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    Summary
    EudraCT Number:2011-004777-89
    Sponsor's Protocol Code Number:CAS/B/016611
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-05
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-004777-89
    A.3Full title of the trial
    Efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) compared to placebo in patients with episodic tension-type headache (ETTH)
    Wirksamkeit und Sicherheit von Euminz® (10 % Ethanol-Pfefferminz-Öl-Lösung zur äußerlichen Anwendung) verglichen mit Placebo bei Patienten mit episodischen Kopfschmerzen vom Spannungstyp
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to demonstrate the efficacy and safety of Euminz® (10% ethanolic solution of peppermint oil for topical use) to reduce the intensity of headache symptoms experienced by patients with episodic tension-type headache compared to placebo
    Klinische Studie zur Wirksamkeit und Sicherheit von Euminz® (10 %
    Ethanol-Pfefferminz-Öl-Lösung zur äußerlichen Anwendung) die Intensität von Kopfschmerzsymptomen bei Patienten mit episodischen Kopfschmerzen vom Spannungstyp im Vergleich zu Placebo zu verringern
    A.3.2Name or abbreviated title of the trial where available
    „Efficacy of Euminz® for Tension-Type Headache“
    Wirksamkeit von Euminz® bei Spannungskopfschmerzen
    A.4.1Sponsor's protocol code numberCAS/B/016611
    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 SponsorCassella-med GmbH & Co. KG
    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 supportCassella-med GmbH & Co.KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCassella-med GmbH & Co.KG
    B.5.2Functional name of contact pointMedical Science Division
    B.5.3 Address:
    B.5.3.1Street AddressGereonsmühlengasse 1
    B.5.3.2Town/ cityKöln
    B.5.3.3Post code50670
    B.5.3.4CountryGermany
    B.5.4Telephone number4903072007755
    B.5.5Fax number4903072007376
    B.5.6E-mailmwze@cassella-med.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 Yes
    D.2.1.1.1Trade name Euminz®
    D.2.1.1.2Name of the Marketing Authorisation holderCassella-med GmbH&CoKG
    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.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8006-90-4
    D.3.9.3Other descriptive namePEPPERMINT OIL
    D.3.9.4EV Substance CodeSUB12550MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    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 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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 placeboCutaneous solution
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic tension-type headache
    Episodischer Kopfschmerz vom Spannungstyp
    E.1.1.1Medical condition in easily understood language
    Headache
    - headache attacks lasting from 30 minutes to 7 days
    - Pressing or lightening (non-pulsating) quality)
    - Intensity of pain: moderate
    - Bilateral location
    Kopfschmerzen
    - Dauer der Kopfschmerzattacken von 30 Minuten bis 7 Tage
    - nicht pulsierend, ziehender oder drückender Schmerz
    - mäßiger Schmerz
    - beidseitiger Schmerz
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10043270
    E.1.2Term Tension headache (excl migraine)
    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 main objective of this prospective, multi-centre, double-blind, placebo-controlled, phase IV clinical trial is to demonstrate the efficacy of Euminz to reduce the intensity of headaches symptoms after topical use during episodic headache attack experienced by patients with episodic tension-type headache.
    Das primäre Ziel dieser prospektiven, multizentrischen, doppelblinden, Placebo-kontrollierten, Phase IV Studie ist die Untersuchung zur Wirksamkeit von Euminz bei Kopfschmerzen vom Spannungstyp. Die äußerliche Anwendung von Euminz während einer Kopfschmerz-Attacke soll die Intensität der Kopfschmerzen reduzieren.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - further headache attacks will be documented and evaluated during study duration (VPRS, VAS)
    - sum of pain intensity differences (SPID) will be calculated over all episodes
    - development of associated pericranial tenderness, esp. neck pain under treatment (physical examination, NDI, NPAD)
    - use of rescue medication
    - any other additional therapy for TTH
    - increase of pain relief measured by verbal pain relief scale (VPRfS)
    - efficacy of the treatment by a global patient´s assessment
    - efficacy of the treatment by a global investigator`s assessment
    - global comparative of treatment by a global investigator`s assessment
    - further pain development, headache reccurance (240 minutes and 24 hours after treatment, respectively)
    - safety: Physical examinations, overall assessments both by the patient and the investigator, vital signs, adverse events.
    Sekundäre Zielkriterien:
    -Beurteilung weiterer Kopfschmerz-Attacken, Beschreibung dieser als verbal pain relief scale (VPRfS) u. visual anlogue scale (VAS)
    -Messung der Sum of pain intensity differences (SPID)
    -Auftreten von, mit dem Kopfschmerz einhergehender, perikranialer Schmerzempfindlichkeit, besonders Nackenschmerzen während der Behandlung (NDI, NPAD)
    -Eingenommene Schmerzmittel, während einer Attacke
    -Alternative Behandlungen bei einer Attacke
    -Dokumentation der Schmerzlinderung durch eine Bewertungsskala; "verbal pain relief scale" (VPRfS)
    -globale Beurteilung der Behandlung durch Patient u. Arzt
    - globale Beurteilung der Behandlung durch Patient
    - Schmerzentwicklung (240 min. nach der Behandlung) und Wiederkehr des Kopfschmerzes (24 Stunden nach der Behandlung)
    - Sicherheit: Körperliche Untersuchung, Gesamtbeurteilung der Auswirkungen der Behandlung durch Patient u. Arzt, Vitalparameter, unerwünschte Ereignisse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female patients from 18 years onwards
    -History of episodic tension-type headache for at least one year. The number of days with such a headache is ≥2 per month
    -Onset of tension-type headache below 65 years of age
    -At least 10 previous headache attacks fulfilling the following four inclusion criteria:
    - Patients with headache attacks lasting from 30 minutes to 7 days
    - At least two of the following pain characteristics are present:
    ­Pressing or tightening (non-pulsating) quality
    ­Intensity of pain: moderate = unable to ignore (pain may inhibit, but does not prohibit activities)
    ­Bilateral location
    ­No aggravation by walking stairs or similar routine physical activity
    - Headache is not accompanied by nausea or vomiting (anorexia may occur)
    - Headache is not accompanied by a combination of the following symptoms: photophobia and phonophobia (only one may be present)
    -3 months retrospective history
    -Willingness and ability to keep the patient’s diary
    and to comply with the procedures of the study
    -Written informed consent
    -männliche und weibliche Patienten ab 18 Jahren
    -Auftreten von episodischen Kopfschmerzen vom Spannungstyp seit mindestens einem Jahr (mind. ≥2 Tage/Monat)
    -Beginn des Auftretens von episodischen Kopfschmerzen vom Spannungstyp unter 65 Jahren
    -10 der vorangegangenen Kopfschmerzattacken erfüllten die vier folgenden Kriterien:
    -Dauer der Kopfschmerzattacke mindestens 30 Minuten bis 7 Tage
    -Zwei der folgenden Schmerzcharakteristika traten auf:
    -ziehender oder drückender Schmerz, nicht pulsierend
    -Schmerzintensität: mäßig (unfähig zu ignorieren, Schmerz kann, muss aber nicht, Aktivitäten behindern)
    -beidseitiger Schmerz
    -keine Verschlimmerung des Schmerzes beim Treppensteigen und ähnliche körperliche Aktivitäten
    -Kopfschmerzen sind nicht verbunden mit Übelkeit oder Erbrechen
    -Kopfschmerzen sind nicht verbunden mit einer Kombination folgender Symptome: Licht- und Geräuschempfindlichkeit (ein Symptom darf vorhanden sein)
    -dreimonatige retrospektive Erhebung
    - Bereitschaft und Fähigkeit das Patienten-Tagebuch zu führen
    - unterschriebene Einwilligungserklärung
    E.4Principal exclusion criteria
    -Headaches other than tension-type headache: (e.g. migraine, cluster
    headache, hypertension headache, drug-related headache, analgesic-induced headache, post-traumatic headache; associated migraine attacks are permitted if they are well recognized by the patient and if their frequency during the preceding year has not exceeded one per month)
    -Presence of oromandibular dysfunction
    -History of facial or cranial surgery
    -Use of prophylactic drugs for headache within one month prior to enrolment
    -Use of drugs for acute tension-type headache treatment for ≥ 10 days of headache per month
    -Anticipated problems in adhering to the self-observation procedure (e.g. because of work)
    -Abuse of alcohol, narcotics or other drugs
    -Serious illnesses within the last 3 months (e.g. myocardial infarction, cardiac insufficiency NYHA III and IV, low blood pressure, cerebral insult, diabetes mellitus, neuropathy, changes in the skin or neoplasms in the head)
    -Epilepsy
    -Intake of anti-psychotic, anti-depressant or anti-epileptic medication during the previous month
    -Intake of long-acting non-steroidal anti-inflammatory drugs within the last month
    -Planned start of new pharmacological or non-pharmacological therapies
    -Any significant skin condition affecting face or neck
    -Known hypersensitivity towards peppermint oil
    -Previous use of Euminz® or any other essential oil solutions for headache in the last three months
    -Participation in another clinical trial within the last month
    -Accommodation in an institution at judicial or official request
    -andere Kopfschmerzen als vom Spannungstyp (z.B. Migräne, Clusterkopfschmerz, Kopfschmerzen durch Bluthochdruck, Headache ausgelöst durch Medikamenten, durch Schmerzmittel induzierte Kopfschmerzen, post-traumatische Kopfschmerzen; Migräneattacken dürfen begleitend auftreten, aber nur wenn sie eindeutig durch den Patienten als solche erkannt werden und im vergangenen Jahr nicht mehr als einmal im Monat auftraten
    -oromandibuläre Dysfunktion
    -Operation im Gesichts- oder Kopfbereich
    -Anwendung von prophylaktischen Medikamenten gegen Kopfschmerz während des letzten Monats vor Einschluss
    -Anwendung von Medikamenten für die Behandlung von Spannungskopfschmerz bei mehr als an 10 Tagen Kopfschmerzen im Monat
    -vorhersehbare Probleme sich bei Kopfschmerzattacken selbst zu beobachten (z.B. wegen der Arbeit)
    -Missbrauch von Alkohol, Narkotika und anderen Medikamenten
    -schwere Erkrankungen in den letzten 3 Monaten (Herzinfarkt, Herzinsuffizienz NYHA III und IV, niedriger Blutdruck, Schlaganfall, Diabetes mellitus, Neuropathie, Hautveränderungen oder Tumorentwicklung am Kopf
    -Epilepsie
    -Einnahme von anti-psychotischen Medikamenten, Anti-Depressiva oder anti-epileptischen Medikamenten während des letzten Monats
    -Einnahme von Langzeit-aktiven, nicht-steroidalen, anti-entzündlichen Medikamenten während des letzten Monats
    -Geplanter Start von neuen Therapien mit oder ohne Arzneimittel
    -Hauterkrankung Gesicht oder Nacken betreffend
    -Bekannte Allergie gegen Pfefferminzöl
    -In der Vergangenheit getätigte Einnahme von Euminz® oder Einnahme anderer reiner Öl-Lösungen gegen Kopfschmerzen in den letzten drei Monaten
    -Teilnahme an einer anderen klinischen Studie im letzten Monat
    -Personen, die
    aufgrund behördlicher oder gerichtlicher Anordnung in einer Anstalt untergebracht wurden
    E.5 End points
    E.5.1Primary end point(s)
    -primary efficacy:
    -the pain-free rate after two hours
    -the decrease of intensity of pain measured by a visual analogue scale (VAS).
    - primäre Endpunkte:
    -Rate der Schmerzfreiheit nach 2 Stunden
    -Reduktion der Schmerzintensität gemessen anhand einer visuellen, analogen Skala (visual analogue scale, VAS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    -Acute treatment (3 to 5 time topical use of Euminz®) will start immediately after assessment of a baseline pain intensity of at least moderate pain (3) on a six–step verbal pain rating scale (VPRS). Timepoints: 15, 30, 45, 60, 90 and 120 minutes after start of treatment. Pain-free is defined as 0 or 1 on the VPRS.

    -The difference from measure point 0 (before first application of Euminz®) on the visual analogue scale (VAS) in comparison to 15, 30, 45, 60, 90 and 120 minutes after start of treatment will be shown as area under the curve representing the pain intensity difference (PID).
    -die Behandlung mit Euminz (3-5 maliges Auftragen) startet sofort nach dem der Patient die Intensität des Schmerzen mit Hilfe einer "six–step verbal pain rating scale" (VPRS), dokumentiert hat (Baseline) und die Schmerzintensität auf der Skala mindestens eine Stärke von "moderat" (3) hat. Zeitpunkte der Messungen: 15, 30, 45, 60, 90 und 120 Minuten nach Behandlungsstart. Schmerzfrei ist definiert als Punkt 0 oder 1 auf der VPRS-Skala

    -die Differenz vom Messpunkt 0 (erstes Auftragen von Euminz) auf der visual analogue scale (VAS) verglichen mit den Messpunkten 15, 30, 45, 60, 90 und 120 Minuten nach Behandlungsstart sollen als AUC-Werte (area under the curve) aufgetragen werden und die Differenz der Schmerzintensität nach Behandlung mit Euminz aufzeigen (pain intensity difference, PID).
    E.5.2Secondary end point(s)
    Secondary endpoints:
    -Further headache attacks will be documented and evaluated during the study duration (VPRS, VAS) and described as sum of pain intensity differences (SPID)
    - Decrease in the intensity of pain after two hours compared to the intensity before the first application measured by a visual analogue scale (VAS)
    - Sum of pain intensity differences (SPID) will be calculated over all episodes
    -Development of associated pericranial tenderness, esp. neck pain under treatment (NDI, NPAD-d)
    -Use of rescue medication after two hours
    - Any other additional therapy for TTH
    -Increase of pain relief after the first application measured by a six-step verbal pain relief scale (VPRfS)
    -Global assessment of the efficacy of the treatment after two hours by the patient of every headache episode;
    -Global comparative evaluation of the treatment by the patient of every headache episode
    -Global assessment of the efficacy of the treatment by the investigator after 10 weeks by the investigator
    -further pain development, headache recurrance (240 minutes and 24 hours after treatment, respectively)
    -Safety of the treatment
    Sekundäre Endpunkte:
    -Dokumentation und Beurteilung weiterer Kopfschmerzattacken während der Studiendurchführung (VPRS; VAS), Beschreibung dieser als "sum of pain intensity differences (SPID)
    -Abnahme der Schmerzintensität nach 2 Stunden verglichen mit der Schmerzintensität während des ersten Auftragens des Prüfpräparates gemessen mittels VAS
    -Messung der "sum of pain intensity differences" (SPID) bei allen auftretenden Episoden
    -das Auftreten von, mit dem Kopfschmerz einhergehender, perikranialer Schmerzempfindlichkeit, besonders Nackenschmerzen während der Behandlung (NDI, NPAD-d)
    -Einnahme von Schmerzmittel nach zwei Stunden
    -Dokumentation jeder zusätzlichen Therapie für TTH
    -Steigerung der Schmerzlinderung nach der ersten Anwendung, gemessen anhand eines "six-step verbal pain relief scale" (VPRfS)
    -globale Beurteilung der Wirksamkeit von Euminz nach 2-stündiger Behandlung durch den Patienten bei jeder aufgetretenen Episode
    -globale vergleichende Beurteilung durch den Patienten
    -globale Beurteilung der Wirksamkeit der Behandlung nach 10 Wochen durch den Prüfarzt
    -Beobachtung der Schmerzentwicklung, Wiederkehr des Kopfschmerzes (240 min. und 24 Stunden nach Behandlung)
    -Sicherheit der Behandlung
    E.5.2.1Timepoint(s) of evaluation of this end point
    •VPRS sum of pain intensity differences (SPID) after 15, 30, 45, 60, 90, 120 min. referred to baseline;
    •Decrease in the intensity of pain after two hours compared to the intensity before the first application measured by a visual analogue scale (VAS);
    •VAS sum of pain intensity differences (SPID) after 15, 30, 45, 60, 90, 120 min. referred to baseline;
    •Development of associated pericranial tenderness, esp. neck pain under treatment (NDI, NPAD-d);
    •Increase of pain relief two hours after the first application measured by a six-step verbal pain relief scale (VPRfS);
    •VPRfS sum of pain relief scores (TOTPAR) after 15, 30, 45, 60, 90, 120 min.
    •VPRS sum of pain intensity differences (SPID) nach 15, 30, 45, 60, 90 und 120 Minuten
    •Abnahme der Schmerzintensität nach 2 Stunden verglichen mit der Schmerzintensität während des ersten Auftragens des Prüfpräparates gemessen mittels VAS;
    •VAS sum of pain intensity differences (SPID) for all time-points during two hours referred to baseline;
    •Steigerung der Schmerzlinderung zwei Stunden nach der ersten Anwendung gemessen mit einem "six-step verbal pain relief scale" (VPRfS);
    •VPRfS Summe der Ergebnisse der Schmerzlinderung (TOTPAR) gemessen nach 15, 30, 45, 60, 90, 120 min.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 trial2
    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 concerned2
    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 No
    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
    LVLS
    letzte Visite des zuletzt eingeschlossenen Probanden
    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 months0
    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 months0
    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: 186
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 186
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    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 state186
    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 subject has ended the participation the treatment is not different from the expected normal treatment of that condition.
    Nach der Teilnahme an der Studie, wird sich die Behandlung nicht von der herkömmlichen Behandlung von Spannungskopfschmerzen unterscheiden.
    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 Decision2012-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-04
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