Back to resultsEfficacy and Safety of Zolmitriptan by Sublingual Administration
Primary Purpose
Cluster Headache
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
zolmitriptan by sublingual administration
zolmitriptan by oral
Sponsored by
About this trial
This is an interventional treatment trial for Cluster Headache focused on measuring Cluster headache, zolmitriptan, Sublingual administration
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Active group
Experimental group
Arm Description
The treatment with oral zolmitriptan is 2.5mg when headache attack.
The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
The percentage of discontinued the drug
The percentage of discontinued the drug because of side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03377257
Brief Title
Efficacy and Safety of Zolmitriptan by Sublingual Administration
Official Title
Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache
Keywords
Cluster headache, zolmitriptan, Sublingual administration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active group
Arm Type
Active Comparator
Arm Description
The treatment with oral zolmitriptan is 2.5mg when headache attack.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.
Intervention Type
Drug
Intervention Name(s)
zolmitriptan by sublingual administration
Other Intervention Name(s)
zolmitriptan
Intervention Description
Experimental group
Intervention Type
Drug
Intervention Name(s)
zolmitriptan by oral
Intervention Description
Active group
Primary Outcome Measure Information:
Title
The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet
Description
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
Time Frame
5, 10, 15 minutes after administration
Secondary Outcome Measure Information:
Title
The percentage of side effects;
Description
The difference of the percentage of side effects in 3 hours after the administration between sublingual and oral zolmitriptan tablet
Time Frame
3 hours
Title
The percentage of discontinued the drug
Description
The percentage of discontinued the drug because of side effects
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li, MD
Phone
00862984775365
Email
lili@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Li li, MD
Phone
008613709115155
Email
lilee@263.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Li, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
cluster headache
Learn more about this trial
Efficacy and Safety of Zolmitriptan by Sublingual Administration
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