Prophylactic Treatment of Episodic Cluster Headache
- Registration Number
- NCT00184587
- Lead Sponsor
- Norwegian University of Science and Technology
- Brief Summary
The purpose of this study is to determine whether candesartan cilexetil are effective prophylactic treatment of episodic Cluster headache
- Detailed Description
Cluster headache is an unilateral headache with periodic attacks, that usually lasts for 6 to 12 weeks. The pain is usually unbearable. The attacks are treated with injections of sumatriptan (migraine medication)and inhalation of oxygen.
The most common prophylactics today has limited effect and a risk of side effects.
Candesartan has in one study shown a clinically significant effect in migraine prophylaxis.
The angiotensin II receptor blocker, candesartan is well tolerated with side-effects not significantly different from placebo and with few drug interactions. We therefore wish to investigate the prophylactic effect in treatment of cluster in headache patients.
This will be a multicenter, double-blind, randomized, parallel study where the prophylactic effect of candesartan is compared to placebo in a period of 3 weeks. First week 16 mg and the following 2 weeks 32 mg.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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. At the time of inclusion, the cluster headache period shall not have lasted more than 3 weeks
- Pregnancy, nursing, decreased hepatic og renal function, psychiatric illness, cardiac problems, hypersensitivity to candesartan, previous serious allergic reaction to medication, chronic cluster headache, drug/alcohol abuse, use of antipsychotic,antidepressants, lithium or other prophylactic treatment less than one month prior to inclusion, systolic blood pressure below 110 mmHg, use of other hypertensive medication, use og other specific attack medication than sumatriptan injection or oxygen 7-10l/min and inability to change medication, use of other triptans than sumatriptan during the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo placebo one tablet/day in week 1 and 2 tablets/day in week 3, provided for the study by AstraZeneca. Same size, weight, taste and appearance as experimental drug candesartan candesartan cilexetil candesartan cilexetil 16 mg (one tablet/day) in week 1 and 32 mg (2 tablets/day) in week 3, provided for the study by AstraZeneca
- Primary Outcome Measures
Name Time Method frequency of attacks per week change from 'pseudobaseline' week 1 to week 3
- Secondary Outcome Measures
Name Time Method level of disability change from 'pseudobaseline' week 1 to week 3 5-point scale; 0= no disability, 1= mild, 2= moderate, 3= severe, 4= unbearable
duration of attacks change from 'pseudobaseline' week 1 to week 3 hours with cluster headache change from 'pseudobaseline' week 1 to week 3 days with cluster headache change from 'pseudobaseline' week 1 to week 3 occurrence of autonomic symptoms change from 'pseudobaseline' week 1 to week 3 number of treatments with sumatriptan or oxygen change from 'pseudobaseline' week 1 to week 3 patient satisfaction with treatment change from 'pseudobaseline' week 1 to week 3 scale from 1 to 10 with 1= very poor effect and 10= very good effect
headache severity index change from baseline to 1 week and 3 week product of level of disability and duration of attacks
candesartan-responders 3 weeks patients with a 50% or more reduction in attack frequency in week 3 than in week 1
placebo-responders 3 weeks patients with a 50% or more reduction in attack frequency in week 3 than in week 1
Trial Locations
- Locations (1)
Norwegian National Headache Centre St.Olavs Hospital
🇳🇴Trondheim, Norway