E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066636 |
E.1.2 | Term | Chronic migraine |
E.1.2 | System Organ Class | 100000004852 |
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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 |
The primary objective of this study, is to investigate any change in disability associated with chronic migraine disorder in the two treatment arms (greater occipital nerve block versus placebo procedure).
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E.2.2 | Secondary objectives of the trial |
a. To assess change in participant headache frequency and severity, b. To assess the change in participant anxiety and depression levels, c. To assess the safety and tolerability in the two treatment arms. d. To assess the eligibility criteria, recruitment and retention of participants in the two treatment arms. e. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Age over 18 and ability to provide written consent. 2.Diagnosis of chronic migraine with or without acute relief medication overuse (ICHD-II codes 1.5.1 and 1.6.5); as confirmed by diary documentation (headache on 15 or more days a month for at least 3 months). 3.Ability to read and write English (questionnaire use in the study) |
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E.4 | Principal exclusion criteria |
1.Patient refusal. 2.Participation in another trial of any investigational products or interventional research project within the previous 8 weeks. 3.Patients unable to commit to the 6-month study duration. 4.Patients with known hypersensitivity to the investigational medicinal products used in the study. 5.Patients with a history of substance abuse. 6.Pregnant or breastfeeding patients.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome being measured in this study is improvement in disability associated with chronic migraine disorder as assessed by: • Change in the Headache Impact Test (HIT-6) questionnaire score • Change in the Migraine-Specific Questionnaire (MSQ) score • Change in the 12-item Short Form Health Survey (SF-12) questionnaire score |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner).
Cross over 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). |
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E.5.2 | Secondary end point(s) |
The secondary objectives are to assess: a. change in headache characteristics: frequency & severity (HIT-6 score) b. change in anxiety and depression (HAD scores) c. safety of intervention (SAR/SAE reports) d. tolerability (SAR/SAE reports) e. economic outcomes f. eligibility criteria, recruitment and retention of patients in the two treatment arms (recruitment and retention rates). g. To assess the feasibility and acceptability of the two treatment arms from the point of view of patients and their pain teams (questionnaire upon completion of study and feedback from clinicians regarding overall feasibility/acceptability of the two treatment arms).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). Cross over 4 weeks post treatment 8 weeks post treatment 12 weeks post treatment * every 4 weeks until no more benefit from treatment, or 24 weeks have passed (whichever is sooner). |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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.8.4.1 | 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 | 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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When all follow up data has been collected from every participant in the trial. Each participant will end the study 4 weeks after any benefit has worn off (or 12 weeks after the last intervention if they continue to receive benefit). |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |