TREATMENT OF TOURETTE'S SYNDROME WITH ECOPIPAM
The present invention encompasses methods of treating a subject who has been diagnosed as having a tic disorder or a movement disorder. The tic disorder can be Tourette's Syndrome, and the methods can include the steps of: (a) identifying a subject in need of treatment; and (b) administering to the subject a therapeutically effective amount of a composition comprising a D1/D5 receptor antagonist, a D1/D5 receptor partial agonist, or a mixture thereof. For example, the D1/D5 receptor antagonist can be ecopipam or a pharmaceutically acceptable salt, solvate, hydrate, prodrug, structural analog, metabolite, or polymorph thereof.
1 .- 20 . (canceled)
21 . A method of treating Tourette's Disorder in a human patient, comprising administering to the patient a dose of ecopipam or a pharmaceutically acceptable salt thereof in a range of 0.1 mg/kg body weight to 5 mg/kg body weight per day.
22 . The method of claim 21 , wherein the dose is in a range of 1 mg/kg body weight to 5 mg/kg body weight per day of ecopipam or pharmaceutically acceptable salt thereof.
23 . The method of claim 22 , wherein the dose is about 2 mg/kg body weight of ecopipam or pharmaceutically acceptable salt thereof.
24 . The method of claim 21 , wherein the ecopipam or pharmaceutically acceptable salt thereof comprises ecopipam hydrochloride.
25 . The method of claim 21 , wherein the ecopipam or pharmaceutically acceptable salt thereof is administered orally.
26 . The method of claim 25 , wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated in a unit dosage form.
27 . The method of claim 26 , wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated as a capsule, tablet, pill, powder, or syrup.
28 . The method of claim 21 , wherein the dose of ecopipam or pharmaceutically acceptable salt thereof per day is administered once daily, or in divided doses twice or three times daily.
29 . The method of claim 28 , wherein the dose of ecopipam or pharmaceutically acceptable salt thereof is administered once daily.
30 . The method of claim 21 , wherein the patient is not older than 18 years.
31 . The method of claim 21 , wherein the patient is free from one or more conditions in the group of attention-deficit-hyperactivity disorder, depression, and obsessive-compulsive disorder.
32 . The method of claim 21 , wherein the patient is free from attention-deficit-hyperactivity disorder, depression, and obsessive-compulsive disorder
33 . The method of claim 21 , further comprising a step of administering a second treatment for treating the tic disorder
34 . The method of claim 33 , wherein the second treatment is a behavioral, surgical, or pharmaceutical therapy
35 . The method of claim 21 , further comprising a step of administering to the subject a therapeutically effective amount of a second composition for the treatment of one or more conditions chosen from attention-deficit-hyperactivity disorder, depression, and obsessive-compulsive disorder.
36 . The method of claim 21 , wherein the administration is in the absence of an environmental modification comprising a trigger.
37 . A method of treating Tourette's Disorder in a human patient, comprising administering to the patient a dose of ecopipam or a pharmaceutically acceptable salt thereof in a range of 50 mg to 500 mg per day.
38 . The method of claim 37 , wherein the dose is in a range of 50 mg to 350 mg per day of ecopipam or pharmaceutically acceptable salt thereof.
39 . The method of claim 38 , wherein the dose is in a range of 50 mg to 250 mg per day of ecopipam or pharmaceutically acceptable salt thereof.
40 . The method of claim 37 , wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated in a unit dosage form.
41 . The method of claim 40 , wherein the unit dosage form comprises the ecopipam or pharmaceutically acceptable salt thereof in a range of 30 mg to 40 mg.
42 . The method of claim 40 , wherein the unit dosage form comprises the ecopipam or pharmaceutically acceptable salt thereof in a range of 50 mg to 100 mg.
43 . The method of claim 40 , wherein the ecopipam or pharmaceutically acceptable salt thereof is formulated as a capsule, tablet, pill, powder, or syrup.
44 . The method of claim 37 , wherein the dose of ecopipam or pharmaceutically acceptable salt thereof per day is administered once daily, or in divided doses twice or three times daily.
45 . The method of claim 44 , wherein the dose of ecopipam or pharmaceutically acceptable salt thereof is administered once daily.
46 . The method of claim 37 , wherein the ecopipam or pharmaceutically acceptable salt thereof comprises ecopipam hydrochloride.
47 . The method of claim 37 , wherein the ecopipam or pharmaceutically acceptable salt thereof is administered orally.
48 . The method of claim 37 , wherein the patient is not older than 18 years.
49 . The method of claim 37 , wherein the administration is in the absence of an environmental modification comprising a trigger.
50 . A method of treating Tourette's Disorder in a human patient not older than 18 years, comprising administering to the patient once daily oral dosages of ecopipam or a pharmaceutically acceptable salt thereof at a daily dose in a range of about 1 mg/kg body weight to about 5 mg/kg body weight.