Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184587
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
2005-09-13
Brief Title:
Prophylactic Treatment of Episodic Cluster Headache
Sponsor:
Norwegian University of Science and Technology
Organization:
Norwegian University of Science and Technology
Study Overview
Official Title:
Prophylactic Treatment of Episodic Cluster Headache With an Angiotensin II Receptor Blocker Candesartan Cilexetil a Randomized Placebo Controlled Parallel Study
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 medicationand 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10815 | OTHER | NSD | None |
| 2004-002737-39 | EUDRACT_NUMBER | None | None |
| 045-04 | OTHER | None | None |