A Phase 4 interventional study of zolmitriptan by sublingual administration and zolmitriptan by oral in Cluster Headache, sponsored by Xijing Hospital. Status unknown. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Xijing Hospital · Phase 4, Interventional, and Treatment
The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.
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.
123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.
This study's planned enrollment of 71 is above the median of 42 across 90 interventional studies indexed under Cluster Headache.
Browse Cluster Headache studies →Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment with oral zolmitriptan is 2.5mg when headache attack.
Drug: zolmitriptan by oral
The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack.
Drug: zolmitriptan by sublingual administration
Experimental group
Also known as: zolmitriptan
Active group
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
Time frame: 5, 10, 15 minutes after administration
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
Time frame: 3 hours
The percentage of discontinued the drug
The percentage of discontinued the drug because of side effects
Time frame: 3 days
No study locations are listed for this record.
Plan to share: Undecided — cluster headache
No publications or documents are linked to this record.
Start is estimated for Jan 2018; primary completion for Dec 2018, 11 months later.
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This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zolmitriptan