Claims for Patent: 12,129,247

Summary for Patent: 12,129,247

Title:	Administration regime for nitrocatechols
Abstract:	A compound of formula (I)where R1, R2, X, Y, n, m, R3, R4, R5, R6 and R7 are as defined herein, for use in the prophylaxis or treatment of a central and peripheral nervous system disorder, wherein the compound of formula (I) is administered prior to sleep, before bedtime or at bedtime.
Inventor(s):	Patricio Manuel Vieira Araujo Soares Da Silva, Teresa Lucia Silva Pereira NUNES, Lyndon Christopher WRIGHT, Pedro Nuno Leal Palma, David Alexander Learmonth
Assignee:	Bial Portela and Cia SA
Application Number:	US16/114,430
Patent Claims:	1. A method of treating Parkinson's disease, comprising orally administering to a human patient suffering from said disease, without food and/or between intakes of food, a therapeutically effective amount of compound 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadiazol-5-yl]-3-nitrobenzene-1,2-diol or a pharmaceutically acceptable salt thereof, wherein the compound is administered in combination with a therapeutically effective amount of levodopa. 2. The method according to claim 1, wherein the compound is administered from 0.25 to 12 hours after an intake of food. 3. The method according to claim 1, wherein the compound is administered from 0.25 to 2 hours before an intake of food. 4. The method according to claim 1, wherein the compound is administered less than one hour prior to sleep, less than one hour before bedtime or at bedtime. 5. The method according to claim 1, wherein the compound is administered at least one hour after the most recent intake of food and at least one hour before the next intake of food by the patient. 6. The method according to claim 1, wherein the compound is administered in a single daily dose. 7. The method according to claim 1, wherein the compound is administered before or after levodopa. 8. The method according to claim 7, wherein the compound is administered from 30 to 150 minutes before or after levodopa. 9. The method according to claim 1, wherein the compound is administered at least one hour before or after the last daily dose levodopa. 10. The method according to claim 1, wherein levodopa is administered sequentially or concomitantly with an aromatic L-amino acid decarboxylase inhibitor (AADCi). 11. The method according to claim 10, wherein the AADCi is carbidopa or benserazide. 12. The method according to claim 2, wherein the compound is administered from 0.5 to 6 hours after an intake of food. 13. The method according to claim 2, wherein the compound is administered from 0.75 to 4 hours after an intake of food. 14. The method according to claim 3, wherein the compound is administered from 0.5 to 1.5 hours before an intake of food. 15. The method according to claim 1, wherein 50 mg of the compound is administered in each dosing periodicity. 16. The method according to claim 1, wherein 25 mg of the compound is administered in each dosing periodicity. 17. The method according to claim 1, wherein the 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadiazol-5-yl]-3-nitrobenzene-1,2-diol or pharmaceutically acceptable salt thereof is administered orally as a solid form.