Efficacy and Safety of Zolmitriptan by Sublingual Administration

Study Overview
=================
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.

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

Conditions
-----------------
Cluster Headache

Intervention / Treatment
-----------------
* Drug: zolmitriptan by sublingual administration
* Drug: zolmitriptan by oral


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active group<br>The treatment with oral zolmitriptan is 2.5mg when headache attack. | Drug: zolmitriptan by oral<br>* Active group<br>|
| Experimental: Experimental group<br>The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack. | Drug: zolmitriptan by sublingual administration<br>* Experimental group<br>* Other names: zolmitriptan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet | 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 | 5, 10, 15 minutes after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of side effects; | The difference of the percentage of side effects in 3 hours after the administration between sublingual and oral zolmitriptan tablet | 3 hours | 
| The percentage of discontinued the drug | The percentage of discontinued the drug because of side effects | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cluster headache, zolmitriptan, Sublingual administration