Methods of treating behavioral symptoms of neurological and mental disorders
AssigneeCuremark, LLC
InventorsJoan M. Fallon, Matthew F. HEIL, James SZIGETHY, Kenneth NANUS, James J. FALLON
Life of this patent
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Abstract
Disclosed herein are methods of using coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations for treatment of subjects having behavioral disorders, neurological disorders or mental health disorders. Disclosed herein are methods of treating core and non-core symptoms of behavioral disorders, neurological disorders or mental health disorders. Also disclosed herein are products for use in methods of treatment and methods of making the same.
Claims235
A method of treating a subject with one or more symptoms of an ASD, comprising:
- administering to the subject a pharmaceutical composition comprising one or more excipients and a therapeutic composition, wherein the therapeutic composition comprises protease, amylase and/or lipase,
- wherein the subject exhibits improvement in one or more symptoms of an ASD comprising:
- (a) protein intake, fat intake, carbohydrate intake, vitamin intake, diarrhea, constipation, seizures, and/or bone fragility;
- and/or
- (b) hyperactivity, irritability, agitation, obsessive compulsive behavior, eye contact, speech, lethargy, hypersensitivity, stereotypy, toilet training, non-compliance, inattention, aggression, impulsivity, conduct disorder, or oppositional defiance and/or social withdrawal and wherein the subject has a greater improvement in the one or more symptoms of an ASD after administration of the pharmaceutical composition than a subject a subject with one or more symptoms of an ASD administered a placebo.
A method of improving expressive and/or receptive language capabilities a subject with a symptom of an ASD, comprising administering a pharmaceutical composition comprising one or more excipients and a therapeutic composition, wherein the therapeutic composition comprises protease, amylase and/or lipase.
A method of treating a subject with one or more symptoms of an ASD, comprising:
- administering to the subject a pharmaceutical composition comprising one or more excipients and a therapeutic composition, wherein the therapeutic composition comprises protease, amylase and/or lipase,
- wherein the subject exhibits improvement in one or more symptoms of an ASD comprising:
- (a) protein intake, fat intake, carbohydrate intake, vitamin intake, seizures, and/or bone fragility;
- and/or
- (b) irritability, agitation, lethargy, hypersensitivity, non-compliance, aggression, impulsivity, conduct disorder, or oppositional defiance and/or social withdrawal and wherein the subject has at least a 10% or greater improvement in the one or more symptoms of an ASD after administration of the pharmaceutical composition.
A method of increasing body mass, or physical growth in a subject with a symptom of an ASD, comprising administering a pharmaceutical composition comprising one or more excipients and a therapeutic composition, wherein the therapeutic composition comprises protease, amylase and/or lipase.
A method of treating a subject with a PDD, ADD or ADHD in need thereof with a pharmaceutical composition comprising:
- administering the pharmaceutical composition comprising one or more pancreatic digestive enzymes to the subject, wherein the subject shows a reduction in the severity or frequency of one or more symptoms associated with a PDD, ADD or ADHD after administration of the pharmaceutical composition.
A method of treating a subject with a PDD, ADD or ADHD in need thereof with a pharmaceutical composition comprising:
- administering the pharmaceutical composition comprising one or more pancreatic digestive enzymes to the subject, wherein the subject has a vitamin K deficiency, and wherein the subject shows a reduction in the severity or frequency of one or more symptoms associated with a ASD, ADD or ADHD after administration of the pharmaceutical composition.
A method of treating a subject with a ASD, ADD or ADHD in need thereof with a pharmaceutical composition comprising:
- administering the pharmaceutical composition comprising:
- 1) one or more pancreatic digestive enzymes;
- 2) glutamate enhancing therapy;
- and/or 3) vitamin K to the subject, wherein the subject has a vitamin K deficiency or an abnormal fecal chymotrypsin level, and wherein the subject shows a reduction in the severity or frequency of one or more symptoms associated with a ASD, ADD or ADHD after administration of the pharmaceutical composition.
A method of treating a subject with a ASD, ADD or ADHD in need thereof with a pharmaceutical composition comprising:
- administering the pharmaceutical composition comprising one or more pancreatic digestive enzymes to the subject, wherein the subject has a vitamin K deficiency, and wherein the subject shows a reduction in the severity or frequency of one or more symptoms associated with a ASD, ADD or ADHD after administration of the pharmaceutical composition.
A method of treating a subject with one or more symptoms of an ASD, comprising:
- Administering to the subject a pharmaceutical composition comprising one or more excipients and a therapeutic composition, wherein the therapeutic composition comprises protease, amylase and/or lipase,
- wherein the subject exhibits improvement in one or more symptoms of an ASD, wherein the subject has one or more allergies and has a larger intake of fiber, calories, fat, protein, and carbohydrates after administration of the pharmaceutical composition than a subject that did not have allergies.
Dependencies are inferred from the claim text.