Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH083707 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| Massachusetts General Hospital | OTHER |
| Seattle Children's Hospital | OTHER |
| University of California, Los Angeles |
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The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).
Pervasive Developmental Disorders (PDDs) are a group of conditions that includes Autistic Disorder, Asperger's disorder and so called Pervasive Developmental Disorder - Not Otherwise Specified. Children with PDD show delays in speech and language and reduced social interaction. Some children with PDD have also have problems with overactivity, impulsiveness and distractability. These behaviors are seen in children with Attention Deficit Hyperactivity Disorder (ADHD). Extended release guanfacine (Intuniv) is FDA-approved for the treatment of children with ADHD. The purpose of this study is to evaluate whether Intuniv is an effective treatment for ADHD symptoms in children with PDD.
This study has four parts: an 8-week double-blind trial, an 8-week blinded extension phase (for positive responders only), an 8-week open-label trial, and a 4-week add-on study. Following confirmation of eligibility, participants will be randomly assigned to receive either guanfacine or placebo in the 8-week double-blind trial. Children who show improvement after 8 weeks of treatment will continue on their assigned treatment for an additional 8 weeks (blinded extension phase). Children who show partial improvement with guanfacine will be offered 4 weeks of treatment with guanfacine plus methylphenidate (add-on study). Children who show no improvement on placebo will be offered 8 weeks of treatment with guanfacine (open-label trial). Children who show no improvement on guanfacine will exit the study.
Side effects and treatment response will be assessed at regularly scheduled visits.
The study protocol was formally revised with the Yale University IRB in May 2013 to address an early close to enrollment due to a reduction in funding. The original anticipated enrollment numbers of 112 subjects was reduced to 60 subjects. The study statistician was consulted prior to enrollment closure to address any issues related to statistical power and the adjustments made to the final statiscal analysis plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended-release guanfacine | Experimental |
| |
| Inactive placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Other | Administered for up to 8 weeks. |
| |
| extended-release guanfacine |
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist Hyperactivity Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| ADHD Rating Scale - Total | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Scahill, MSN, PhD | Emory University | Principal Investigator |
| James McCracken, MD | University of California, Los Angeles | Principal Investigator |
| Bryan King, MD | Seattle Children's Hospital | Principal Investigator |
| Christopher McDougle, MD | Massachusetts General Hospital | Principal Investigator |
| James Dziura, MPH, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90024 | United States | ||
| Yale University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17069547 | Background | Scahill L, Aman MG, McDougle CJ, McCracken JT, Tierney E, Dziura J, Arnold LE, Posey D, Young C, Shah B, Ghuman J, Ritz L, Vitiello B. A prospective open trial of guanfacine in children with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2006 Oct;16(5):589-98. doi: 10.1089/cap.2006.16.589. | |
| 37811711 | Derived | Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2. |
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81 total patients screened. 13 ineligible. 6 Declined
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended-release Guanfacine | extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks |
| FG001 | Inactive Placebo | placebo: Administered for up to 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Extended-release Guanfacine | extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks |
| BG001 | Inactive Placebo | placebo: Administered for up to 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Aberrant Behavior Checklist Hyperactivity Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 8 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended-release Guanfacine | extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aggressive | Psychiatric disorders | Subject became verbally and physically agressive |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Scahill, MSN, PhD | Emory University | lawrence.scahill@emory.edu |
Not provided
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D013035 | Spasm |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000067877 | Autism Spectrum Disorder |
| D020879 | Neuromuscular Manifestations |
Not provided
Not provided
| ID | Term |
|---|---|
| D016316 | Guanfacine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
Not provided
Not provided
| OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
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Not provided
| Drug |
1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks |
|
|
| Week 8 |
| Aberrant Behavior Checklist Irritability Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 - 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45. | 8 weeks |
| Aberrant Behavior Checklist Social Withdrawal Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48. | 8 weeks |
| Aberrant Behavior Checklist Sterotypy Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21. | 8 weeks |
| Aberrant Behavior Checklist Inappropriate Speech Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12. | 8 weeks |
| ADHD Rating Scale - Inattention Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity. | 8 weeks |
| ADHD Rating Scale - Hyperactivity Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity. | 8 weeks |
| Aberrant Behavior Checklist Hyperactivity Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48. | Baseline |
| Aberrant Behavior Checklist Irritability Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45. | Baseline |
| Aberrant Behavior Checklist Social Withdrawal Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48. | Baseline |
| Aberrant Behavior Checklist Sterotypy Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21. | Baseline |
| Aberrant Behavior Checklist Inappropriate Speech Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12. | Baseline |
| ADHD Rating Scale - Inattention Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity. | Baseline |
| ADHD Rating Scale - Hyperactivity Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity. | Baseline |
| ADHD Rating Scale - Total | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity. | Baseline |
| New Haven |
| Connecticut |
| 06519 |
| United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Massachusetts General Hospital | Lexington | Massachusetts | 02142 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98101 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Inactive Placebo | placebo: Administered for up to 8 weeks. |
|
|
| Secondary | ADHD Rating Scale - Total | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Week 8 |
|
|
|
| Secondary | Aberrant Behavior Checklist Irritability Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. It is a 58 item checklist which takes about 10 - 15 minutes to complete. There are five subscales: a) Irritability and Agitation b) Lethargy and Social Withdrawal c) Stereotypic Behavior d) Hyperactivity and Noncompliance and e) Inappropriate Speech. The higher the number of items (score), the greater the amount of symptoms. Scores can range from 0 to 45. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
|
|
| Secondary | Aberrant Behavior Checklist Social Withdrawal Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
|
|
| Secondary | Aberrant Behavior Checklist Sterotypy Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
|
|
| Secondary | Aberrant Behavior Checklist Inappropriate Speech Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
|
|
| Secondary | ADHD Rating Scale - Inattention Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
|
|
| Secondary | ADHD Rating Scale - Hyperactivity Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring,with a higher score indicating greater severity. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
|
|
| Secondary | Aberrant Behavior Checklist Hyperactivity Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers over-activity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. The range of scores is 0 to 48. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| Secondary | Aberrant Behavior Checklist Irritability Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. Scores for this subscale can range from 0 to 45. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| Secondary | Aberrant Behavior Checklist Social Withdrawal Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 48. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| Secondary | Aberrant Behavior Checklist Sterotypy Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 21. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| Secondary | Aberrant Behavior Checklist Inappropriate Speech Subscale | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 with mental retardation. The full ABC is a 58-item parent-rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials of children with developmental disabilities. The interpretation of the tool and its sub-scales is that a greater number of items, indicates greater severity. This subscale's scores can range from 0 to 12. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| Secondary | ADHD Rating Scale - Inattention Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| Secondary | ADHD Rating Scale - Hyperactivity Subscale | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. This subscale can range from 0 to 27 for scoring, with a higher score indicating greater severity. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| Secondary | ADHD Rating Scale - Total | The ADHD Rating Scale (ADHD-RS) is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder with established reliability, validity and sensitivity to change. The ADHD Rating Scale-IV is completed independently by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. Results from this rating scale alone should not be used to make a diagnosis. The total score can range from 0 to 54, with a higher score indicating greater severity. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline |
|
|
|
| 1 |
| 30 |
| 30 |
| 30 |
| EG001 | Inactive Placebo | placebo: Administered for up to 8 weeks. | 0 | 32 | 25 | 32 |
| Fatigue | General disorders |
|
| Decreased Appetite | General disorders |
|
| Emotional/tearful | General disorders |
|
| Dry Mouth | Gastrointestinal disorders |
|
| Irritability | General disorders |
|
| Anxiety | Psychiatric disorders |
|
| Headache | Nervous system disorders |
|
| Increased Energy | General disorders |
|
| Mid sleep awakening | Psychiatric disorders |
|
| Stomachache | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Increased Repetitive Behavior | Psychiatric disorders |
|
| Aggression | Psychiatric disorders |
|
| Depressed Mood | Psychiatric disorders |
|
| Cough/Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Self-injury | Psychiatric disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Trouble Falling Asleep | Psychiatric disorders |
|
| Dizziness | Nervous system disorders |
|
| Silly | Psychiatric disorders |
|
| Weakness | General disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Increased Appetite | Gastrointestinal disorders |
|
| Excessive Talking | Psychiatric disorders |
|
| Blurred Vision | Eye disorders |
|
| Skin rash/Eczema | Skin and subcutaneous tissue disorders |
|
| Nightmares | Psychiatric disorders |
|
| Enuresis | Renal and urinary disorders |
|
| Motor Tics | Nervous system disorders |
|
| Skin Picking | Skin and subcutaneous tissue disorders |
|
| Fever | General disorders |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |