E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic migraine with and without medication overuse |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10019231 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10027603 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10056236 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
evaluate the efficacy and tolerability of IV haloperidol in the treatment of patients with migraine and Medication Overuse Headache or Chronic migraine without symptomatic drugs |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· pazienti di eta' ≥18 anni · pazienti consecutivamente arruolati nel DH del Centro Cefalee della Farmacologia Clinica dell’AOUCA · diagnosi di emicrania e MOH o emicrania cronica in assenza di uso eccessivo di sintomatici in accordo con i criteri IHS 2004 e revisione 2005 · accettazione consapevole dello studio e conseguente firma del consenso informato |
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E.4 | Principal exclusion criteria |
· malattie cardiache clinicamente significative (ad esempio recente infarto acuto del miocardio, insufficienza cardiaca scompensata, aritmie trattate con farmaci antiaritmici appartenenti alle classi Ia e III) · prolungamento dell’intervallo QTc · soggetti con storia familiare di aritmia o torsione di punta · ipopotassemia non corretta · concomitante uso di farmaci che prolungano il QTc · gravidanza accertata o presunta, allattamento · stati comatosi (compresi quelli indotti da alcool o da altre sostanze attive sul S.N.C.) · disturbi depressivi · morbo di Parkinson · lesioni dei gangli della base (emiplegia, sclerosi a placche etc.) · ipersensibilita' individuale accertata verso il prodotto |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. riduzione del numero di giorni di cefalea / mese 2. riduzione del numero di giorni di assunzione di sintomatici / mese 3. riduzione del grado di disabilita' MIDAS al follow up a 3, 6, 12 mesi, rispetto al basale 4. riduzione del punteggio all’HIT-6, alla dimissione e a 1,3,6 e 12 mesi di follow up, rispetto al basale
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |