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This is a five-arm designed to assess the safety of L1-79 that incorporates 15 prospectively randomized, placebo controlled patients and 5 open label patients at either 100 tid (three times daily) or 200 tid dosing for 28 days. The open label patients will be assessed for the purpose of understanding PK/PD and to determine if there are any EKG changes associated with the administration of L1-79. Additional safety information will be provided by the 30 patients randomized 2:1 active:placebo.
Protocol Number: HT 02-121
Protocol Title: Phase 2 Safety Study of L1-79 for the Treatment of Autism Study Phase: 2
The first cohort of 20 patients to be enrolled will all receive L1-79 100 mg t.i.d., and will be comprised of 3 groups of patients. The first group of patients to receive 100 mg will differ from the others in that they will get blood samples drawn for PK analysis and EKGs will be taken. The safety and PK data from this group will be submitted for FDA review and acceptance before the 200 mg t.i.d. cohort will be enrolled. The remaining 15 patients in this cohort will be randomized to receive either L1-79 100 mg t.i.d. or placebo on a 2:1 basis (2 L1-79 patients for each placebo patient). While the FDA is reviewing the data from the first 5 patients all 100 mg t.i.d. patients will continue to be treated.
The second cohort is identical to the first. The initial 5 patients to be enrolled will differ from the others in that they will get blood samples drawn for PK analysis and EKGs will be taken. The remaining 15 patients in this cohort will be randomized to receive either L1-79 200 mg t.i.d. or placebo on a 2:1 active:placebo.
Sample Size: N=40
Study Population: Male subjects with autism between the ages of 13 and 21 years of age who meet the entry criteria and who are able to complete standardized measures allowing them to participate in this study.
Evaluation Schedule: Subjects will be evaluated within one week prior to study accession, and weekly throughout the dosing period, and again 4 weeks after the cessation of treatment. The Assigned Dosage Groups (Groups 1 and 3) will have PK blood draws and EKG the randomized group will not have.
Safety Measures: All Groups will have regularly scheduled complete history and physical examination that includes orthostatic blood pressure measurements, vital signs, CBC, differential, platelet counts, urine analysis, and serum analytes including: total protein, albumin, glucose, BUN, creatinine, direct and total bilirubin, alkaline phosphatase, phosphorous, calcium, AST, ALT, sodium, potassium, chloride, bicarbonate, T4, TSH, and adverse events assessments. The Assigned Groups (1 and 3) will also have electrocardiograms taken at the study screening visit and weekly throughout the treatment interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100 mg open | Experimental | open-label lead-in 100 mg L1-79 t.i.d. |
|
| 100 mg blinded | Experimental | blinded and randomized 100 mg L1-79 t.i.d. |
|
| 200 mg open | Experimental | open-label lead-in 200 mg L1-79 t.i.d. |
|
| 200 mg blinded | Experimental | blinded and randomized 200 mg L1-79 t.i.d. |
|
| Placebo | Placebo Comparator | placebo t.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L1-79 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of Participants with On-treatment Adverse Events. To be conservative, it was pre-specified that all placebo data be combined (open-label, first cohort, and second cohort) for the safety population. For the efficacy population open-label data was excluded due to potential bias and placebo arms from the first and second cohort were presented separately due to differences in efficacy questionnaires completion in the first and second cohorts. Theses differences were not relevant to the adverse event data. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression Scale (CGI) | The Clinical Global Impression (CGI) has two components: the CGI-Severity (CGI-S), which rates illness severity, and the CGI-Improvement (CGI-I), which rates the change in illness severity from baseline. The CGI-S is rated on the following seven-point scale with 1 being normal and 7 being among the most extremely ill subjects. The CGI-I score is rated on a seven-point scale with 1 being very much improved and 7 being very much worse. Higher values of the CGI-S score indicate a "worse" state. CGI-I scores of 5 or greater indicate decline, CGI I scores of 3 or lower indicate improvement, and a CGI-I score of 4 indicates no change. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Rothman, PhD | Yamo Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric Bartky MD, Bartky Health Care Center | Livingston | New Jersey | 07039 | United States | ||
| F. Peter Halas MD, Sea Girt Pediatrics |
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| ID | Title | Description |
|---|---|---|
| FG000 | 100 mg Open | open-label lead-in L1-79 100 mg tid |
| FG001 | 100 mg Blinded | blinded and randomized L1-79 100 mg tid |
| FG002 | Placebo (100 mg Cohort) | blinded and randomized placebo tid |
| FG003 | 200 mg Open | open-label lead-in L1-79 200 mg tid |
| FG004 | 200 mg Blinded | blinded and randomized L1-79 200 mg tid |
| FG005 | Placebo (200 mg Cohort) | blinded and randomized placebo tid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 100 mg Open | open-label lead-in 100 mg L1-79 t.i.d. L1-79 |
| BG001 | 100 mg Blinded | blinded and randomized 100 mg L1-79 t.i.d. L1-79 |
| 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 | Adverse Events | Number of Participants with On-treatment Adverse Events. To be conservative, it was pre-specified that all placebo data be combined (open-label, first cohort, and second cohort) for the safety population. For the efficacy population open-label data was excluded due to potential bias and placebo arms from the first and second cohort were presented separately due to differences in efficacy questionnaires completion in the first and second cohorts. Theses differences were not relevant to the adverse event data. | Safety Population. Note that all Placebo data (open-label, first cohort and second cohort) is combined for the safety population. However for the efficacy population the open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Number | participants | 4 weeks |
|
From the time of screening to the end of the study (28-day treatment period with 4-week post-treatment follow-up)
To be conservative, it was pre-specified that all placebo data be combined (open-label, first cohort, and second cohort) for the safety population. For the efficacy population open-label data was excluded due to potential bias and placebo arms from the first and second cohort were presented separately due to differences in efficacy questionnaires completion in the first and second cohorts. Theses differences were not relevant to the adverse event data.
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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 | 100 mg Open | open-label lead-in 100 mg L1-79 tid | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Non-systematic Assessment |
The study enrolled a small number of patients and was not powered to detect statistically significant changes in efficacy parameters. Also note that assessments (except CGI and ADOS-2) for 100 mg cohort were completed by caregivers at home. Due to missing/incomplete data for endpoints completed at home, study procedures changed for 200 mg cohort and assessments were completed in clinic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Fischer | Yamo Pharmaceuticals | 8596855862 | tfischer@yamopharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2018 | Mar 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Placebo | Drug |
|
| Week 0 and Week 4 |
| Change From Baseline in Vineland Adaptive Behavior Scale - 2nd Edition Socialization Standard Score | The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) indicates adaptive functioning and consists of four major domains. Only the communication and socialization domains were done in this study. The VABS-II data is comprised of Socialization. Socialization Standard Scores may range from 20 to 160, with a population mean of 100 and a standard deviation of 15. Lower Vineland Adaptive Behavior Socialization Standard Scores indicate a "worse" state. A positive value of change from baseline indicates improvement. | Day 0 and Week 4 |
| Change From Baseline in Vineland Adaptive Behavior Scale - 2nd Edition Communication Standard Score | The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) indicates adaptive functioning and consists of four major domains. Only the communication and socialization domains were done in this study. The VABS-II is comprised of Communication. Communication Standard Scores may range from 20 to 160, with a population mean of 100 and a standard deviation of 15. Lower Vineland Adaptive Behavior Communication Standard Scores indicate a "worse" state. A positive value of change from baseline indicates improvement. | Week 0 and Week 4 |
| Change From Baseline in the Autism Diagnostic Observation Schedule 2nd Edition (ADOS-2) Overall Total Score | The Autism Diagnostic Observation Schedule 2nd Edition (ADOS-2) is the "Gold Standard" for assessing severity of ASD and position on the autism spectrum. The ADOS-2 is a semi-structured, standardized assessment of: Communication, Social interaction, Play, and Restricted and repetitive behaviors. The total scores range from 15 to 60, and the cut-off score to determine autism is 30. More specifically, a score of <30 is classified as non-autism, a score of 30-36 is classified as mild to moderate autism, and a score of ≥37 is classified as severe autism. A higher ADOS-2 value indicates a "worse" state. A negative value of change from baseline indicates an improvement. | Day 0 and Week 4 |
| Change From Baseline in the Social Responsiveness Scale - 2nd Edition (SRS-2) Total T-score | Social Responsiveness Scale - 2nd edition (SRS-2) identifies social impairment associated with ASD and quantifies its severity. Raw and T-scores will be collected for SRS-2 Total, Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Interest and Repetitive Behavior, DSM-5 Social Communication, and DSM-5 Restrictive Interest and Repetitive Behavior. Each domain has a varied but similar ranges of possible scores from 32 points-114 points. All T-scores have a mean of 50 points with a standard deviation of 10 points. A higher SRS-2 total T-score indicates greater impairment. A negative change from baseline indicates improvement. | Week 0 and Week 4 |
| Change From Baseline in Aberrant Behavior Checklist - Community (ABC-C) | The Aberrant Behavior Checklist - Community (ABC-C) is a 58-symptom checklist for assessing problem behaviors of children and adults with developmental disabilities (intellectual disability, ASD, cerebral palsy, epilepsy) that resolve onto five subscales. The subscales and the respective number of items are as follows: (a) irritability (15 items, scores range from 0-45), (b) lethargy/social withdrawal (16 items, scores range from 0-48), (c) stereotypic behavior (7 items, scores range from 0-21), (d) hyperactivity/noncompliance (16 items, scores range from 0-48), and (e) inappropriate speech (4 items, scores range from 0-12). Higher ABC-C subscale scores indicates a "worse" outcome. A negative value of change from baseline indicates improvement. | Week 0 to Week 4 |
| Change From Baseline in the Repetitive Behavior Scale - Revised (RBS-R) Total Score | The RBS-R is a 43-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. Behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. The total score is the sum of all 6 subscale scores and ranges from 0-127, stereotypic behavior ranges from 0-18, self-injurious behavior ranges from 0-24, compulsive behavior ranges from 0-24, ritualistic behavior ranges from 0-18, sameness behavior ranges from 0-33 and restricted behaviors ranges from 0-12. A higher RBS-R score indicates a "worse" state. A negative value of change from baseline indicates an improvement. | Week 0 and Week 4 |
| Sea Girt |
| New Jersey |
| 07850 |
| United States |
| BG002 | Placebo Blinded (100 mg Cohort) | blinded and randomized placebo t.i.d. Placebo (100 mg cohort) |
| BG003 | 200 mg Open | open-label lead-in 200 mg L1-79 t.i.d. L1-79 |
| BG004 | 200 mg Blinded | blinded and randomized 200 mg L1-79 t.i.d. L1-79 |
| BG005 | Placebo Blinded (200 mg Cohort) | blinded and randomized placebo t.i.d. Placebo (200 mg cohort) |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 100 mg Open |
open-label lead-in 100 mg L1-79 tid |
| OG001 | 100 mg Blinded | blinded and randomized 100 mg L1-79 tid |
| OG002 | 200 mg Open | open-label lead-in 200 mg L1-79 tid |
| OG003 | 200 mg Blinded | blinded and randomized 200 mg L1-79 tid |
| OG004 | Placebo Blinded (100 mg Cohort) | blinded and randomized placebo tid (100 mg cohort) |
| OG005 | Placebo Blinded (200 mg Cohort) | blinded and randomized placebo tid (200 mg cohort) |
|
|
| Secondary | Change From Baseline in Clinical Global Impression Scale (CGI) | The Clinical Global Impression (CGI) has two components: the CGI-Severity (CGI-S), which rates illness severity, and the CGI-Improvement (CGI-I), which rates the change in illness severity from baseline. The CGI-S is rated on the following seven-point scale with 1 being normal and 7 being among the most extremely ill subjects. The CGI-I score is rated on a seven-point scale with 1 being very much improved and 7 being very much worse. Higher values of the CGI-S score indicate a "worse" state. CGI-I scores of 5 or greater indicate decline, CGI I scores of 3 or lower indicate improvement, and a CGI-I score of 4 indicates no change. | Efficacy Population Note that for the efficacy population open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Mean | Standard Error | score on a scale | Week 0 and Week 4 |
|
|
|
|
| Secondary | Change From Baseline in Vineland Adaptive Behavior Scale - 2nd Edition Socialization Standard Score | The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) indicates adaptive functioning and consists of four major domains. Only the communication and socialization domains were done in this study. The VABS-II data is comprised of Socialization. Socialization Standard Scores may range from 20 to 160, with a population mean of 100 and a standard deviation of 15. Lower Vineland Adaptive Behavior Socialization Standard Scores indicate a "worse" state. A positive value of change from baseline indicates improvement. | Efficacy Population Note that for the efficacy population open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Mean | Standard Deviation | score on a scale | Day 0 and Week 4 |
|
|
|
| Secondary | Change From Baseline in Vineland Adaptive Behavior Scale - 2nd Edition Communication Standard Score | The Vineland Adaptive Behavior Scales, Second Edition (VABS-II) indicates adaptive functioning and consists of four major domains. Only the communication and socialization domains were done in this study. The VABS-II is comprised of Communication. Communication Standard Scores may range from 20 to 160, with a population mean of 100 and a standard deviation of 15. Lower Vineland Adaptive Behavior Communication Standard Scores indicate a "worse" state. A positive value of change from baseline indicates improvement. | Efficacy Population Note that for the efficacy population open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Mean | Standard Deviation | score on a scale | Week 0 and Week 4 |
|
|
|
| Secondary | Change From Baseline in the Autism Diagnostic Observation Schedule 2nd Edition (ADOS-2) Overall Total Score | The Autism Diagnostic Observation Schedule 2nd Edition (ADOS-2) is the "Gold Standard" for assessing severity of ASD and position on the autism spectrum. The ADOS-2 is a semi-structured, standardized assessment of: Communication, Social interaction, Play, and Restricted and repetitive behaviors. The total scores range from 15 to 60, and the cut-off score to determine autism is 30. More specifically, a score of <30 is classified as non-autism, a score of 30-36 is classified as mild to moderate autism, and a score of ≥37 is classified as severe autism. A higher ADOS-2 value indicates a "worse" state. A negative value of change from baseline indicates an improvement. | Efficacy Population Note that for the efficacy population open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Mean | Standard Deviation | score on a scale | Day 0 and Week 4 |
|
|
|
| Secondary | Change From Baseline in the Social Responsiveness Scale - 2nd Edition (SRS-2) Total T-score | Social Responsiveness Scale - 2nd edition (SRS-2) identifies social impairment associated with ASD and quantifies its severity. Raw and T-scores will be collected for SRS-2 Total, Social Awareness, Social Cognition, Social Communication, Social Motivation, Restricted Interest and Repetitive Behavior, DSM-5 Social Communication, and DSM-5 Restrictive Interest and Repetitive Behavior. Each domain has a varied but similar ranges of possible scores from 32 points-114 points. All T-scores have a mean of 50 points with a standard deviation of 10 points. A higher SRS-2 total T-score indicates greater impairment. A negative change from baseline indicates improvement. | Efficacy Population Note that for the efficacy population open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Mean | Standard Deviation | score on a scale | Week 0 and Week 4 |
|
|
|
| Secondary | Change From Baseline in Aberrant Behavior Checklist - Community (ABC-C) | The Aberrant Behavior Checklist - Community (ABC-C) is a 58-symptom checklist for assessing problem behaviors of children and adults with developmental disabilities (intellectual disability, ASD, cerebral palsy, epilepsy) that resolve onto five subscales. The subscales and the respective number of items are as follows: (a) irritability (15 items, scores range from 0-45), (b) lethargy/social withdrawal (16 items, scores range from 0-48), (c) stereotypic behavior (7 items, scores range from 0-21), (d) hyperactivity/noncompliance (16 items, scores range from 0-48), and (e) inappropriate speech (4 items, scores range from 0-12). Higher ABC-C subscale scores indicates a "worse" outcome. A negative value of change from baseline indicates improvement. | Efficacy Population Note that for the efficacy population open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Mean | Standard Deviation | score on a scale | Week 0 to Week 4 |
|
|
|
| Secondary | Change From Baseline in the Repetitive Behavior Scale - Revised (RBS-R) Total Score | The RBS-R is a 43-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. Behaviors are rated on a 4-point scale: 0-Behavior does not occur, 1-Behavior occurs and is a mild problem, 2-Behavior occurs and is a moderate problem, 3-Behavior occurs and is a severe problem. The total score is the sum of all 6 subscale scores and ranges from 0-127, stereotypic behavior ranges from 0-18, self-injurious behavior ranges from 0-24, compulsive behavior ranges from 0-24, ritualistic behavior ranges from 0-18, sameness behavior ranges from 0-33 and restricted behaviors ranges from 0-12. A higher RBS-R score indicates a "worse" state. A negative value of change from baseline indicates an improvement. | Efficacy Population Note that for the efficacy population open-label data is excluded and placebo arms from the first cohort and second cohort are presented separately because in the first cohort questionnaires were filled out at home by patients and in the second cohort they were completed in clinic with study staff. | Posted | Mean | Standard Deviation | score on a scale | Week 0 and Week 4 |
|
|
|
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | 100 mg Blinded | blinded and randomized 100 mg L1-79 tid | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | 200 mg Open | open-label lead-in 200 mg L1-79 tid | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | 200 mg Blinded | blinded and randomized 200 mg L1-79 tid | 0 | 11 | 0 | 11 | 6 | 11 |
| EG004 | Placebo Blinded (100 mg Cohort) | blinded and randomized placebo tid (100 mg cohort) | 0 | 5 | 0 | 5 | 0 | 5 |
| EG005 | Placebo Blinded (200 mg Cohort) | blinded and randomized placebo tid (200 mg cohort) | 0 | 5 | 0 | 5 | 3 | 5 |
| fatigue | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| pyrexia | General disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| seasonal allergy | Immune system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| ear infections | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| otitis externa | Infections and infestations | MedDRA (19.1) | Non-systematic Assessment |
|
| amylase increased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| blood TSH increased | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| crystal urine present | Investigations | MedDRA (19.1) | Non-systematic Assessment |
|
| generalized tonic-clonic seizure | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| agitation | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| confusional state | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| intentional self injury | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| irritability | Psychiatric disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| urinary incontinence | Renal and urinary disorders | MedDRA (19.1) | Non-systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Non-systematic Assessment |
|
Not provided
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| Clinical Global Impression - Improvement |
|
| ANCOVA |
| 0.33 |
| Mean Difference (Final Values) |
| -0.53 |
| Standard Error of the Mean |
| 0.52 |
| 2-Sided |
| Superiority |
| Clinical Global Impression - Improvement | ANCOVA | 0.61 | Mean Difference (Final Values) | 0.25 | Standard Error of the Mean | 0.47 | 2-Sided | Superiority |
| Clinical Global Impression - Improvement | ANCOVA | 0.91 | Mean Difference (Final Values) | 0.05 | Standard Error of the Mean | 0.43 | 2-Sided | Superiority |
| social awareness T-score |
|
| social cognition T-score |
|
| social communication T-score |
|
| social motivation T-score |
|
| RRB T-score |
|
| DSM-5 social communication interaction T-score |
|
| DSM-5 RRB T-score |
|
| lethargy and social withdrawal |
|
| stereotypic behavior |
|
| hyperactivity and noncompliance |
|
| inappropriate speech |
|
| stereotypic behavior |
|
| self-injurious behavior |
|
| compulsive behavior |
|
| ritualistic behavior |
|
| sameness behavior |
|
| restricted behavior |
|