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 | 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 |
To show that repeated GON-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.
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E.2.2 | Secondary objectives of the trial |
To determine - If the effect of one GON-injection predict the effects of subsequent GON-injections. - The median GON-injection interval. - The tolerability of repeated GON-injections . - Structural integrity of the GON after the study period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age ≥18 - Chronic cluster headache (International Classification of Headache Disorders – third edition; ICHD-3) - Ictal pain must be always at the same side - ≥8 weekly attacks of cluster headache in the prospective one-month baseline observation period - On a stable regimen of cluster headache prophylactics for >4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period
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E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study: - Contra-indication against, or current use of, corticosteroids - Occipital nerve stimulation (ONS) - Use of anticoagulation medication or a known bleeding disorder - Inability to use an electronic diary to monitor individual attacks and other items - Other headaches if the patient cannot reliably distinguish them from attacks of cluster headache - Current use of prophylactic medication for other headaches - Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Retention rate (= time between the first injection and end-of-treatment; survival curves verum vs. placebo) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After one year follow up (52 weeks) |
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E.5.2 | Secondary end point(s) |
- Frequency of daily cluster headache attacks - The use of acute attack medication per day (subcutaneous sumatriptan and 100% oxygen) - Mean duration and severity (1-10) of attacks - Injection interval - Total number of injections in study period - Proportion of participants still in study at 1 year - Participants idea: did they receive placebo or verum? - Physician’s idea: did they administer placebo or verum? - Adverse events + ultrasound structural integrity measurements greater occipital nerve - Proportion of subjects with a >50% and 100% reduction in attack frequency - Daily quality of life (EQ 5D) - Healthcare use & productivity losses
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After one year follow up (52 weeks) |
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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 | 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 | Yes |
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) | Yes |
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 | 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) | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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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 |