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

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

Study Overview

• Status: Unknown
• Conditions: Cluster Headache
• Intervention / Treatment: Drug: zolmitriptan by oral; Drug: zolmitriptan by sublingual administration

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 Type: Interventional
• Enrollment (Anticipated): 71
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Li Li, MD; Phone Number: 00862984775365; Email: lili@fmmu.edu.cn
• Study Contact Backup: Name: Li li, MD; Phone Number: 008613709115155; Email: lilee@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active group; The treatment with oral zolmitriptan is 2.5mg when headache attack.	Drug: zolmitriptan by oral; Active group
Experimental: Experimental group; The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.	Drug: zolmitriptan by sublingual administration; Experimental group; Other Names: zolmitriptan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet	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	5, 10, 15 minutes after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of side effects;	The difference of the percentage of side effects in 3 hours after the administration between sublingual and oral zolmitriptan tablet	3 hours
The percentage of discontinued the drug	The percentage of discontinued the drug because of side effects	3 days

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Li Li, MD, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Cluster headache; Sublingual administration; zolmitriptan
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Serotonin Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Protein Synthesis Inhibitors; Oxazolidinones; Zolmitriptan
• Other Study ID Numbers: Xijing-CH-zolmi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: cluster headache

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No