Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-25 @ 4:32 PM
Study NCT ID:
NCT03377257
Status:
UNKNOWN
Last Update Posted:
2017-12-19
First Post:
2017-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Zolmitriptan by Sublingual Administration
Sponsor:
Xijing Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
NOT_YET_RECRUITING
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 is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.
Detailed Description:
Cluster headache is a primary neurological disorder characterized by intensive attacks and severe sharp headache, can cause a range of symptoms such as conjunctival congestion, runny nose, miosis, forehead sweat. The disability resulting from cluster headache can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using oral zolmitriptan as the control, is to evaluate the effectiveness and safety of zolmitriptan by sublingual administration for the acute treatment of cluster headache. Patients are asked to maintain a headache diary throughout the treatment period.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: