E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Episodic cluster headache |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whether candesartan cilexetil has a prophylactic effect in the treatment of episodic cluster headache patients.
This is a randomized, placebo controlled parallell study.
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy parameters:
A) Level of disability:
0 = No headache 1 = Mild headache, able to continue with daily activities 2 = Moderate headache 3 = Severe headache 4 = Unbearable headache
B) Duration of attacks
C) Hours with cluster headache
D) Days with cluster headache
E) Hours with headache
F) Days with headache
G) Occurrence of autonomic symptoms
H) Number of attacks treated with sumatriptan or oxygen.
I) Doses of sumatriptan
J) Acceptability of treatment
K) Comparison between the last two weeks on medication and the week with headache diary only.
L) Days with sick leave
M) Headache severity index (headache hours x level of disability)
N) Doses of analgesics
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Signed, written informed consent - Male or female aged 18-75. - At the time of inclusion, the cluster headache period shall not have lasted more than 3 weeks. - The episodic cluster headache must be diagnosed according to the IHS classification. - Had at least one episode with cluster headache before inclusion. - Previously had at least one cluster headache episode lasting one month or more. - The patient can separate the cluster headache from other types of headache.
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E.4 | Principal exclusion criteria |
- Pregnancy, nursing or inability to use contraceptives - Decreased hepatic or renal function. - Systolic blood pressure below 110 mmHg - Hypersensitivity towards candesartan cilexetil. - Previous history of serious allergic reaction to a medication. - Psychiatric illness preventing full participation. - Use of lithium within 4 weeks prior to inclusion and within 2 weeks for other cluster headache prophylactic medications. - Cardiac problems - Use of diuretics - Use of other specific attack medication than sumatriptan or oxygen 7-10 l/min and the inability to change to this medication. (Pain killers like acetylic acid, paracetamol, ibuprofen etc. is allowed). - Use of other triptans than sumatriptan or ergotamines during the study period. - Chronic cluster headache. - Those who abuse drugs, including headache treatments, and alcohol. - The use of antipsychotics or antidepressants one month prior to inclusion.
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency of attacks per week. |
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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 | Yes |
E.6.3 | Therapy | No |
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 | Information not present in EudraCT |
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 | 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 | Information not present in EudraCT |
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.8.3 |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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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The study ends when 64 patients have been included. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |