E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Episodic cluster headache |
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E.1.1.1 | Medical condition in easily understood language |
Episodic cluster headache |
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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 provide a definitive answer regarding the efficacy of GON-injection as first-line prophylactic therapy in episodic cluster headache, by showing that GON-injection decreases the mean total dose of verapamil needed during the treatment of a cluster episode in episodic cluster headache. |
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E.2.2 | Secondary objectives of the trial |
To Show that the addition of GON-injection leads to - faster attack-freedom (7 consecutive days without attacks) than the current standard treatment with verapamil only. - less side-effects than the current standard treatment with only verapamil. - a decrease in attack frequency, severity and duration of attacks (and thus a decrease in the use of attack medication) compared to the current standard treatment with only verapamil. To learn how long the beneficial effects of GON-injection will last. To show that GON-injection will lead to higher patient satisfaction scores, compared to the current standard treatment with only verapamil. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients have to be diagnosed with episodic cluster headache according to the international classification of headache disorders – third edition beta, ICHD-3b - Patients have to be aged 18-65 years - Patients need to be newly diagnosed and treatment naïve, or already diagnosed and currently free from prophylactic treatment - Patients need to have a mean of more than 1 attack per day in the 3 days preceding inclusion. - Patients should be in their cluster period for shorter than 4 weeks before inclusion. |
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E.4 | Principal exclusion criteria |
- A contraindication for treatment with steroids or verapamil - The use of anticoagulants or known bleeding disorder. - Use of any prophylactic medication for cluster headache - Patients with a history of other primary headache who are currently using prophylactic medication for this headache - Pregnancy |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the decrease in mean total dose of verapamil used per day during the study period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary endpoints: 1. Median number of days to remission (7 consecutive days without attack) 2. Mean number of attacks per day 3. Peak dose verapamil 4. Premature termination of study due to need for prophylactic escape medication
Tertiary endpoints 5. The total use of attack medication 6. Mean number, severity (1-10) and duration of attack per day. 7. Percentage of patients that are attack-free at days 7, 14 and 28 8. Occurrence of ‘non-cluster’ headache (number of days and mean intensity per affected day) 9. Adverse events 10. Subjective feeling at days 7, 14 and 28 (visual analogue scale, VAS) 11. Satisfaction score (7 point scale, higher scores are better) 12. Would the patient recommend this treatment to others? 13. What treatment does the patient think he/she received (placebo/GON/uncertain)? 14. What treatment do the investigators think the patient has had? |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every day in in the complete 12-week study period - 1-6, 8, 9 and 11
At the end of each of the three 4-week timeperiods - 5, 6, 8
Days 7, 14, and 28 - 7, 10
Days 2, 28 and at the end of the 12-week study period - 12, 13 and 14 |
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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) | 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 | 6 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |