Efficacy and Safety of Zolmitriptan by Sublingual Administration

NCT03377257 | Unknown Phase 4 DMC

• 1 other identifier: Xijing-CH-zolmi
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cluster Headache

Keywords

Cluster headache; zolmitriptan; Sublingual administration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The percentage of side effects;

  3 hours

• The percentage of discontinued the drug

  3 days

Study Arms (2)

Active group

ACTIVE COMPARATOR

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

Drug: zolmitriptan by oral

Experimental group

EXPERIMENTAL

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

Drug: zolmitriptan by sublingual administration

Interventions

zolmitriptan by sublingual administration DRUG

Experimental group

Also known as: zolmitriptan

Experimental group

zolmitriptan by oral DRUG

Active group

Active group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Cluster Headache

Interventions

zolmitriptan

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Li Li, MD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Li, MD

CONTACT

00862984775365; lili@fmmu.edu.cn

Li li, MD

CONTACT

008613709115155; lilee@263.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 19, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: April 30, 2019
• Last Updated: December 19, 2017

Record last verified: 2017-05