Topical Bimatoprost in the Treatment of Migraine
Parole chiave
Astratto
Descrizione
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.
Date
| Ultimo verificato: | 03/31/2019 |
| Primo inviato: | 01/22/2018 |
| Iscrizione stimata inviata: | 01/25/2018 |
| Primo pubblicato: | 02/04/2018 |
| Ultimo aggiornamento inviato: | 04/24/2019 |
| Ultimo aggiornamento pubblicato: | 04/25/2019 |
| Data di inizio effettiva dello studio: | 01/04/2018 |
| Data di completamento primaria stimata: | 04/24/2019 |
| Data stimata di completamento dello studio: | 06/29/2019 |
Condizione o malattia
Intervento / trattamento
Drug: Bimatoprost Topical Solution
Drug: Control
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| 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. |
Criteri di idoneità
| Età idonea per lo studio | 18 Years Per 18 Years |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | 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. |
Risultato
Misure di esito primarie
1. Reduction in Headache Frequency [12 weeks]
Misure di esito secondarie
1. Intensity of Headaches [12 weeks]
2. Duration of Headaches [12 weeks]
3. Migraine Disability Assessment Scale (MIDAS)--Quality of Life [12 weeks]
