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Efficacy and Safety of Zolmitriptan by Sublingual Administration

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ClinicalTrials.gov Identifier: NCT03377257
Recruitment Status : Unknown
Verified May 2017 by Xijing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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

Condition or disease Intervention/treatment Phase
Cluster Headache Drug: zolmitriptan by sublingual administration Drug: zolmitriptan by oral Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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 Name: zolmitriptan




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. The percentage of discontinued the drug [ Time Frame: 3 days ]
    The percentage of discontinued the drug because of side effects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377257


Contacts
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Contact: Li Li, MD 00862984775365 lili@fmmu.edu.cn
Contact: Li li, MD 008613709115155 lilee@263.net

Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Li Li, MD Xijing Hospital
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03377257    
Other Study ID Numbers: Xijing-CH-zolmi
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: cluster headache

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
Cluster headache
zolmitriptan
Sublingual administration
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Oxazolidinones
Zolmitriptan
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors