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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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Autism Spectrum Disorders (ASD) include Autistic disorder, Asperger's syndrome and Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). These are developmental disorders beginning prior to three years of age. Recent Centers for Disease Control (CDC) estimates suggest that ASD affects up to 1 in 100 individuals and up to 1 in 50 boys. There are very substantial costs associated with caring for patients with ASD, and ASD has the highest Caregiver Burden Scores of any condition. There are three core symptom domains of ASD, including social deficits, repetitive behaviors and language deficits. Patients can also have associated symptoms of attentional deficits, disruptive behaviors and intellectual disability. There is currently no Food and Drug administration (FDA) approved treatment for the core symptoms of autism, but risperidone and aripiprazole have FDA approval for disruptive behaviors associated with autism.
This is a 12 week randomized double blind placebo controlled trial of Milnacipran in adults with ASD or Aspergers Syndrome. Milnacipran is said to play a role in the activation and normalization of the locus coeruleus-noradrenergic system, of which is hypothesized to play a role in behavior adaptations and performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milnacipran | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milnacipran | Drug | Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale | Change will be measured in each subject's score on the Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale from baseline through study end (week 12).Higher values represent a worse outcome. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem. For example, Row 1 is the mean of baseline T-scores for the Inattention/ Memory subscale and Row 2 is the mean of week 12 T-scores for the Inattention/ Memory subscale. The difference between these two means is used to measure the change from baseline through week 12 for both the groups. | Baseline and Week 12 scores |
| Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale | The Aberrant Behavior Checklist is an informant-based questionnaire consisting of 58 items subdivided amongst 5 scales: irritability, lethargy and social withdrawal, stereotypic behavior, hyperactivity/non-compliance, and inappropriate speech [34]. A score for each item ranges from 0 indicating "no problem" to 3 indicating "severe problem". Scale scores are calculated by summing the items within that scale. Higher scores indicate greater impairment.Reported Data is for change in ABC-H from baseline to endpoint (week 0 to week 12).This data is specifically looking at the hyperactivity scale which is 16 items with each item ranging from 0-3 making total scores 0-48. | Baseline to Endpoint - 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Autism Severity Levels Based on the Clinical Global Impressions Scale | The CGI-I reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from Much Improved (1) to Much worse (5). | screening, baseline, weeks 2,4,6,8,10,12 |
| Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hollander, MD | Montefiore Medical Center/Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center, Albert Einstein College of Medicine | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Milnacipran | Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile. |
| FG001 | Placebo | Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Milnacipran | Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Score on Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale | Change will be measured in each subject's score on the Conners Adults Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale from baseline through study end (week 12).Higher values represent a worse outcome. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem. For example, Row 1 is the mean of baseline T-scores for the Inattention/ Memory subscale and Row 2 is the mean of week 12 T-scores for the Inattention/ Memory subscale. The difference between these two means is used to measure the change from baseline through week 12 for both the groups. | Posted | Mean | Standard Deviation | T-score | Baseline and Week 12 scores |
|
Adverse event data was collected from baseline to endpoint, for 12 weeks total.
By definition, serious Adverse Events includes adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.
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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 | Milnacipran | Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Hollander, MD | Montefiore Medical Center, Albert Eins | 7189204287 | eholland@montefiore.org |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D020817 | Asperger Syndrome |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000078764 | Milnacipran |
| ID | Term |
|---|---|
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Placebo | Drug | Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg. |
|
This scale has been shown to be a sensitive outcome measure in autism trials of repetitive behaviors. Data for secondary outcome not analyzed due to lack of significance in primary outcomes measured.
|
| baseline, weeks 2,4,6,8,10,12 |
| Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF) | This scale is shown to be sensitive to change in adults with autism, and related to amygdala function. Higher scores mean a better outcome.A clinical tool measuring emotion recognition through facial expression, voice and posture.
| baseline, weeks 2,4,6,8,10,12 |
Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Severity of Illness | Scores are using the Clinical Global Impression Scale -Severity (CGI-S). This is a 7-point scale, from 1 (normal not at all ill) to 7 (among the most extremely ill), that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. | Mean | Full Range | units on a scale |
|
| Aberrant Behavior Checklist - Hyperactivity Scale (ABC-H) | ABC-H can assess problematic behavior at home, in educational and work settings, and in residential and community-based facilities specifically in regard to hyperactivity. It is a sub- scale of the larger ABC-2 which rates 58 specific symptoms, and provides comprehensive descriptions, for each assessed behavior. It is further divided into five sub-scales and the one discussed here is hyperactivity. Each question is rated on a scale from 0-3 with 0 being not problematic and 3 being most problematic. | Mean | Full Range | units on a scale |
|
| CAARS Inattention/Memory T Score | The Conners Adult ADHD Rating Scales (CAARS) are the international standard for questionnaire assessment of ADHD. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. This sub-scale being assessed is inattention/ memory. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem. | Mean | Full Range | T score |
|
| CAARS Hyperactivity/Restlessness T Score | The Conners Adult ADHD Rating Scales (CAARS) are the international standard for questionnaire assessment of ADHD. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem.This sub-scale being assessed is hyperactivity/ restlessness. | Mean | Full Range | T score |
|
| CAARS Impulsivity/Emotional Labiality T Score | The Conners Adult ADHD Rating Scales (CAARS) are the international standard for questionnaire assessment of ADHD. The raw scores are converted to T-scores for each scale and sub-scale which are then compared against the mean. Higher values represent a worse outcome. A T-score of 50 is the mean of a relevant reference population. A T-score above 65 indicates a moderate to severe problem.This sub-scale being assessed is impulsivity/ emotional labiality. | Mean | Full Range | T score |
|
Milnacipran: Patients will receive a titrated dose of milnacipran increasing to a maximum of 200mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.
| OG001 | Placebo | Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg. |
|
|
| Primary | Change in Hyperactivity as Measured by Aberrant Behavior Checklist - Hyperactivity Scale | The Aberrant Behavior Checklist is an informant-based questionnaire consisting of 58 items subdivided amongst 5 scales: irritability, lethargy and social withdrawal, stereotypic behavior, hyperactivity/non-compliance, and inappropriate speech [34]. A score for each item ranges from 0 indicating "no problem" to 3 indicating "severe problem". Scale scores are calculated by summing the items within that scale. Higher scores indicate greater impairment.Reported Data is for change in ABC-H from baseline to endpoint (week 0 to week 12).This data is specifically looking at the hyperactivity scale which is 16 items with each item ranging from 0-3 making total scores 0-48. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Endpoint - 12 weeks |
|
|
|
| Secondary | Change in Autism Severity Levels Based on the Clinical Global Impressions Scale | The CGI-I reflects the rater's impression of the subject's current autism severity on a 7-point scale ranging from Much Improved (1) to Much worse (5). | Posted | Count of Participants | Participants | screening, baseline, weeks 2,4,6,8,10,12 |
|
|
|
| Secondary | Change in Repetitive Behaviors Using YBOCS-Compulsion and Rigidity Subscale | This scale has been shown to be a sensitive outcome measure in autism trials of repetitive behaviors. Data for secondary outcome not analyzed due to lack of significance in primary outcomes measured.
| Posted | Mean | Standard Deviation | score on a scale | baseline, weeks 2,4,6,8,10,12 |
|
|
|
| Secondary | Change in Diagnostic Analysis of Nonverbal Activity-2 ADULT FACIAL EXPRESSIONS: (DANVA2-AF) | This scale is shown to be sensitive to change in adults with autism, and related to amygdala function. Higher scores mean a better outcome.A clinical tool measuring emotion recognition through facial expression, voice and posture.
| Posted | Mean | Standard Deviation | score on a scale | baseline, weeks 2,4,6,8,10,12 |
|
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|
| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| EG001 | Placebo | Placebo: Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg. | 0 | 5 | 0 | 5 | 4 | 5 |
| Headache | General disorders | Non-systematic Assessment |
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| Nightmares | General disorders |
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| Weight loss | General disorders |
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| Abdominal Cramping | General disorders |
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| Anal Fissure | Gastrointestinal disorders |
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| Dizziness | General disorders |
|
| Gastroenteritis | Gastrointestinal disorders |
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| Gum Pain | General disorders |
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| Hemorrhoids | General disorders |
|
| Insomnia | General disorders |
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| Lethargy | General disorders |
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| Lightheadedness | General disorders |
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| Menstrual Cramps | General disorders |
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| Nausea | General disorders |
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| Sleep Disruption | General disorders |
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| Stomachache | General disorders |
|
| Somnolence | General disorders |
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| Upper Respiratory Infection | Infections and infestations |
|
| Vomiting | General disorders |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| No Change |
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| Minimally Worse |
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| Much Worse |
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| Week 4 |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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| Week 12 |
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| Week 4 |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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| Week 12 |
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