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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03377257

Enrollment

Registered

2017-12-19

Start date

2018-01-01

Completion date

2019-04-30

Last updated

2017-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cluster Headache

Keywords

Cluster headache, zolmitriptan, Sublingual administration

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.

Interventions

DRUGzolmitriptan by sublingual administration

Experimental group

DRUGzolmitriptan by oral

Active group

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Contacts

Primary ContactLi Li, MD

lili@fmmu.edu.cn00862984775365

Backup ContactLi li, MD

lilee@263.net008613709115155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026