Treatment of tourette's syndrome with ecopipam

Abstract

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.