Episodic cluster headache
Conditions
Interventions
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)
Conce
Sponsors
National Headache Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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 ;Primary end point(s): Frequency of attacks per week. | — |
Countries
Denmark
Outcome results
None listed