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Efficacy and Safety of Zolmitriptan by Sublingual Administration

NCT ID: NCT03377257

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cluster Headache

Keywords

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Cluster headache zolmitriptan Sublingual administration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active group

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

Group Type ACTIVE_COMPARATOR

zolmitriptan by oral

Intervention Type DRUG

Active group

Experimental group

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

Group Type EXPERIMENTAL

zolmitriptan by sublingual administration

Intervention Type DRUG

Experimental group

Interventions

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zolmitriptan by sublingual administration

Experimental group

Intervention Type DRUG

zolmitriptan by oral

Active group

Intervention Type DRUG

Other Intervention Names

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zolmitriptan

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Li, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Central Contacts

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Li Li, MD

Role: CONTACT

Phone: 00862984775365

Email: [email protected]

Li li, MD

Role: CONTACT

Phone: 008613709115155

Email: [email protected]

Other Identifiers

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Xijing-CH-zolmi

Identifier Type: -

Identifier Source: org_study_id