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出境医 / 临床实验 / Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients
Study Description
Brief Summary:
To investigate the role of KATP channels in migraine with aura patients.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Headache Migraine Aura | Drug: Levcromakalim Drug: Saline | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 17 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients |
| Actual Study Start Date : | July 9, 2019 |
| Actual Primary Completion Date : | December 10, 2019 |
| Actual Study Completion Date : | December 10, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Levcromakalim |
Drug: Levcromakalim
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
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| Placebo Comparator: Saline |
Drug: Saline
To investigate the role of levcromakalim compared with placebo in migraine with aura patients
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Outcome Measures
Primary Outcome Measures :
- Headache [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]Occurrence of headache
- Migraine [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]Occurrence of migraine
- Aura [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]Occurrence of aura
Secondary Outcome Measures :
- The area under the curve (AUC) for headache [ Time Frame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline ]Headache intensity
- Family history [ Time Frame: After including the patients in the study. ]Direct interview with the 1 st degree family memeber for included patients according to international classification of headaches.
- Heart rate [ Time Frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline ]Change in heart rate measured in Beats per minute (BPM)
- Blood pressure [ Time Frame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline ]Change in blood pressure measured in mmHg
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Migraine with aura patients of both sexes.
- 18-60 years.
- 50-100 kg.
Exclusion Criteria:
- Headache less than 48 hours before the tests start
- Daily consumption of drugs of any kind other than oral contraceptives
- Pregnant or nursing women.
- Cardiovascular disease of any kind, including cerebrovascular diseases.
Contacts and Locations
Locations
| Denmark | |
| Danish headache center | |
| Glostrup, Denmark, 2600 | |
Sponsors and Collaborators
Danish Headache Center
Investigators
| Study Director: | Messoud Ashina | Danish Headache Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 4, 2019 | ||||
| First Posted Date ICMJE | July 9, 2019 | ||||
| Last Update Posted Date | March 2, 2020 | ||||
| Actual Study Start Date ICMJE | July 9, 2019 | ||||
| Actual Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients | ||||
| Official Title ICMJE | Headache Inducing Effect of Levcromakalim in Migraine With Aura Patients | ||||
| Brief Summary | To investigate the role of KATP channels in migraine with aura patients. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Other |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
17 | ||||
| Original Estimated Enrollment ICMJE |
16 | ||||
| Actual Study Completion Date ICMJE | December 10, 2019 | ||||
| Actual Primary Completion Date | December 10, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Denmark | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04012047 | ||||
| Other Study ID Numbers ICMJE | Journal-nr.: H-19023571 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Mohammad Al-Mahdi Al-Karagholi, Danish Headache Center | ||||
| Study Sponsor ICMJE | Danish Headache Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Danish Headache Center | ||||
| Verification Date | February 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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