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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Active Comparator | The treatment with oral zolmitriptan is 2.5mg when headache attack. |
|
| Experimental group | Experimental | The treatment with zolmitriptan by sublingual administration is 2.5mg when headache attack. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolmitriptan by sublingual administration | Drug | Experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 hours |
| The percentage of discontinued the drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Li, MD | Contact | 00862984775365 | lili@fmmu.edu.cn | |
| Li li, MD | Contact | 008613709115155 | lilee@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Li Li, MD | Xijing Hospital | Principal Investigator |
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cluster headache
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| ID | Term |
|---|---|
| D051303 | Trigeminal Autonomic Cephalalgias |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C089750 | zolmitriptan |
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| zolmitriptan by oral | Drug | Active group |
|
The percentage of discontinued the drug because of side effects
| 3 days |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |