Prophylactic treatment of episodic cluster headache with an angiotensin II receptor blocker (candesartan cilexetil); a randomized, placebo controlled parallel study. - Cluster-candesartan study

INTERVENTION: Trade Name: Atacand Product Name: candesartan cilexetil Pharmaceutical Form: Tablet INN or Proposed INN: candesartan cilexetil Other descriptive name: Atacand Concentration unit: mg milligram(s) Concentration type: range Concentration number: 16‐32 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Episodic cluster headache PRIMARY OUTCOME: Main Objective: 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.; ; ; ; Primary end point(s): Frequency of attacks per week. Secondary Objective: 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; 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range