E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
frequent migraine (defined at least 8 attacks per month) and medication-overuse headache |
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E.1.1.1 | Medical condition in easily understood language |
migraine headache with at least 8 attacks per month and headache induced by overuse of headache medication |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 |
This study was designed to assess the influence of blockade of the greater occipital nerve (ONB) on (1) the frequency of migraine in patients with eight or more migraine days per month, (2) hours with severe or moderate headache within the first 120 hours after withdrawal of acute medication and the proportion of responders to medication-withdrawal in patients with MOH |
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E.2.2 | Secondary objectives of the trial |
- Days with any headache - Duration of headache - Intensity of headache - Use of acute medication - Headache Impact Test - Beck Depression Inventory II (BDI) - Beck Anxiety Inventory (BAI) - Blood glucose levels - Need for another prophylactic treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men or women, aged between 18 and 65 years - Headache diagnoses a) Study 1: Diagnosis of migraine without or with aura according to the criteria of ICHD-II (Tables 1 and 2) and eight or more days of migraine without aura or probable migraine without aura (Table 3) per month on average during the three months preceding study inclusion. b) Study 2: Diagnosis of MOH according to the revised criteria by Silberstein et al. (ICHD-IIR) - Prophylactic therapy of headache: No prophylactic medication and no non-pharmacological headache prophylaxis in the previous three months OR stable prophylactic therapy for three months continued without change throughout the entire study period. - Written informed consent
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E.4 | Principal exclusion criteria |
- Other headache disorders except tension-type headache - Lifetime history of moderate or severe traumatic brain injury or any other cerebral disorder - Mild traumatic brain injury in the previous year - Substance abuse and medication overuse: Study 1: Lifetime history of substance abuse and medication overuse as defined by Silberstein et al. in the previous year. Study 2: Lifetime history of substance abuse except overuse of acute headache medication. Unsuccessful withdrawal therapy for MOH in the previous year. Current overuse of opioids or benzodiazepines - Diabetes mellitus - Known Glaucoma - Uncontrolled hypertension - Known osteoporosis - Gastral or duodenal ulcer in the previous year - Severe liver disease - Obesity (BMI>30) - Current treatment with corticosteroids - Pregnancy or breastfeeding - Change of prophylactic headache treatment in past 8 weeks
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E.5 End points |
E.5.1 | Primary end point(s) |
Migraine: Reduction in days with migraine without aura or probable migraine without aura < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5-8, 9-12, 13-16) MOH: Reduction in das with moderate or severe headache < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5.8, 9-12, 13-16) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Migraine: Reduction in days with migraine without aura or probable migraine without aura < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5-8, 9-12, 13-16) MOH: Reduction in das with moderate or severe headache < 50% comparing baseline (weeks 1-4) to observation periods 1-3 (weeks 5.8, 9-12, 13-16) |
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E.5.2 | Secondary end point(s) |
- Days with any headache - Duration of headache - Intensity of headache - Use of acute medication - Headache Impact Test - Beck Depression Inventory II (BDI) - Beck Anxiety Inventory (BAI) - Blood glucose levels - Need for another prophylactic treatment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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 | No |
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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Last visit of the last included subject |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |