Cluster HeadachePhase 4NCT03377257
Efficacy and Safety of Zolmitriptan by Sublingual Administration
A Phase 4 study testing zolmitriptan by sublingual administration and zolmitriptan by oral in people with Cluster Headache, run by Xijing Hospital.
Trial summary
The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cluster Headache
- What is being tested?
- zolmitriptan by sublingual administration and zolmitriptan by oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 30 Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cluster Headache
- Being tested
- zolmitriptan by sublingual administration, zolmitriptan by oral
- Keywords
- Cluster headache, zolmitriptan, Sublingual administration
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolmitriptan by sublingual administrationDrug
Also called zolmitriptan
Experimental group
zolmitriptan by oralDrug
Active group
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | The treatment with oral zolmitriptan is 2.5mg when headache attack. Receives: Drug: zolmitriptan by oral |
| Experimental group | Experimental | The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack. Receives: Drug: zolmitriptan by sublingual administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5, 10, 15 minutes after administration
Secondary outcomes (2)
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
Measured: 3 hours
The percentage of discontinued the drug
The percentage of discontinued the drug because of side effects
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Li, MD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377257
- Sponsor's protocol ID
- Xijing-CH-zolmi
- Status last verified
- May 2017
- First submitted
- 5 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: cluster headache
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial
- ClinicalTrials.gov ID
- NCT03377257
- Acronym / sponsor ID
- Xijing-CH-zolmi
- Conditions
- Cluster Headache
- Keywords
- Cluster headache, zolmitriptan, Sublingual administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Drug: zolmitriptan by oralThe treatment with oral zolmitriptan is 2.5mg when headache attack. |
| Experimental group | Experimental | Drug: zolmitriptan by sublingual administrationThe treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zolmitriptan by sublingual administrationAlso: zolmitriptanExperimental group | Drug | Experimental group |
| zolmitriptan by oralActive group | Drug | Active group |
Primary outcome
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
2 secondary outcomes
The percentage of side effects;
Time frame: 3 hours
The percentage of discontinued the drug
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: Undecided. cluster headache
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Li, MD principal investigator
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zolmitriptan by sublingual administration and zolmitriptan by oral in people with Cluster Headache, run by Xijing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Li, MD (00862984775365, lili@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet (time frame: 5, 10, 15 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.