Efficacy and Safety of Zolmitriptan by Sublingual Administration

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Cluster Headache

Treatments: Drug: zolmitriptan by oral; Drug: zolmitriptan by sublingual administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03377257

Xijing-CH-zolmi

Details and patient eligibility

About

The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.

Full 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.

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Active group

Active Comparator group

Description:

The treatment with oral zolmitriptan is 2.5mg when headache attack.

Treatment:

Drug: zolmitriptan by oral

Experimental group

Experimental group

Description:

The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.

Treatment:

Drug: zolmitriptan by sublingual administration