Efficacy and Safety of Zolmitriptan by Sublingual Administration

Phase 4

• Conditions: Cluster Headache
• Interventions: Drug: zolmitriptan by sublingual administration; Drug: zolmitriptan by oral

• Registration Number: NCT03377257
• Lead Sponsor: Xijing Hospital

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 Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-12-05
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-13
• Study First Posted: 2017-12-19
• Last Update Posted: 2017-12-19
• Study Start: 2018-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Patients older than or equal to 18 years and less than 70 years;
• The diagnosis of cluster headache is made according to The International Classification of Headache Disorders: 3rd edition (beta version)(ICHD-III β);
• Consent form signed by the participant or his/her authorized surrogate.

Exclusion Criteria

• Patients had primary or secondary headache disorders other than cluster headache;
• Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning a pregnancy in the next year or if they were not using an adequate form of birth control;
• Patients will be excluded if they had significant medical or psychiatric disease;
• Patients will be excluded if they had coronary heart disease or not suitable for the treatment of zolmitriptan.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental group	zolmitriptan by sublingual administration	The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.
Active group	zolmitriptan by oral	The treatment with oral zolmitriptan is 2.5mg when headache attack.

Primary Outcome Measures

Name	Time	Method
The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet	5, 10, 15 minutes after administration	The difference of the percentage of the headache attacks whose visual analogue scale points reduce from 7-10 to 0-3 5, 10, 15 minutes after administration between sublingual and oral zolmitriptan tablet

Secondary Outcome Measures

Name	Time	Method
The percentage of side effects;	3 hours	The difference of the percentage of side effects in 3 hours after the administration between sublingual and oral zolmitriptan tablet
The percentage of discontinued the drug	3 days	The percentage of discontinued the drug because of side effects