NCT03377257

Efficacy and Safety of Zolmitriptan by Sublingual Administration

Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DRUG	zolmitriptan by sublingual administration	Experimental group
DRUG	zolmitriptan by oral	Active group

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-12-31
• Completion: 2019-04-30
• First posted: 2017-12-19
• Last updated: 2017-12-19