Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 71
- Primary Endpoint
- The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Active group
The treatment with oral zolmitriptan is 2.5mg when headache attack.
Intervention: zolmitriptan by oral (Drug)
Experimental group
The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.
Intervention: zolmitriptan by sublingual administration (Drug)
Outcomes
Primary Outcomes
The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet
Time Frame: 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 Outcomes
- The percentage of side effects;(3 hours)
- The percentage of discontinued the drug(3 days)