Topical Bimatoprost in the Treatment of Migraine
Ключавыя словы
Рэферат
Апісанне
Hall, et al. have observed retrospectively that treatment with topical prostaglandin F2 alpha analogs (applied either to the eye or fingernail bed) significantly reduced the frequency, severity and duration of headaches in migraine sufferers, as well as their migraine disability assessment score (MIDAS).
This is a double-blind, placebo-controlled prospective clinical study to determine if the effect of FDA-approved bimatoprost, a prostaglandin F2 alpha analogue, has anti-migraine activity when administered topically to people suffering from migraine.
Даты
| Апошняя праверка: | 03/31/2019 |
| Упершыню прадстаўлена: | 01/22/2018 |
| Меркаваная колькасць заявак прадстаўлена: | 01/25/2018 |
| Першае паведамленне: | 02/04/2018 |
| Апошняе абнаўленне адпраўлена: | 04/24/2019 |
| Апошняе абнаўленне апублікавана: | 04/25/2019 |
| Фактычная дата пачатку даследавання: | 01/04/2018 |
| Разліковая дата першаснага завяршэння: | 04/24/2019 |
| Разліковая дата завяршэння даследавання: | 06/29/2019 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Drug: Bimatoprost Topical Solution
Drug: Control
Фаза
Групы ўзбраенняў
| Рука | Ўмяшанне / лячэнне |
|---|---|
| Experimental: Bimatoprost Topical Solution 0.03% bimatoprost topical solution applied daily to the nail bed of fingers on one hand for 12 weeks | Drug: Bimatoprost Topical Solution One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed |
| Placebo Comparator: Control Saline placebo topically applied daily to the nail be of fingers on one hand for 12 weeks | Drug: Control One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand. |
Крытэрыі прыдатнасці
| Узрост, які мае права на вучобу | 18 Years Каб 18 Years |
| Пол, прыдатны для навучання | All |
| Прымае здаровых валанцёраў | Так |
| Крытэрыі | Inclusion Criteria: - Diagnosis of migraines based on International Classification of Headache Disorders (ICHD) II criteria and experiencing headaches for 4 or more days per month. Exclusion Criteria: - Significant liver or renal dysfunction, - On treatment for inflammatory bowel disease, medication over-use for headaches according to the ICHD II criteria, - Use of antipsychotics in the past month, - Recent (in the past six months) history of alcohol or drug abuse, - Allergy to bimatoprost and its compounds, - Severe comorbid psychiatric illness, - Severe infection, - Malignancy, - Severe cardiovascular disease, - Neurodegenerative disorders, - Pregnancy and lactation, and - Sexually active women of child bearing age who do not use any method of contraception. |
Вынік
Першасныя вынікі
1. Reduction in Headache Frequency [12 weeks]
Меры другаснага выніку
1. Intensity of Headaches [12 weeks]
2. Duration of Headaches [12 weeks]
3. Migraine Disability Assessment Scale (MIDAS)--Quality of Life [12 weeks]
