Efficacy and Safety of Zolmitriptan by Sublingual Administration

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2018

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

  • Drug: zolmitriptan by sublingual administration
    • Experimental group
  • Drug: zolmitriptan by oral
    • Active group

Arms, Groups and Cohorts

  • Active Comparator: Active group
    • The treatment with oral zolmitriptan is 2.5mg when headache attack.
  • Experimental: Experimental group
    • The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • The percentage of side effects;
    • Time Frame: 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
    • Time Frame: 3 days
    • The percentage of discontinued the drug because of side effects

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Xijing Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Li Li, MD, Principal Investigator, Xijing Hospital
  • Overall Contact(s)
    • Li Li, MD, 00862984775365, lili@fmmu.edu.cn

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