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Decision made to terminate due to difficulty in procurement of adequate supply of treatment drug. Decision made on April 2023 to terminate study.
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| Name | Class |
|---|---|
| Autism Science Foundation | OTHER |
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The proposed project will pilot the use of IGF-1 as a novel treatment for core symptoms of autism. We will use a double-blind, placebo-controlled crossover trial design in five children with autism to evaluate the impact of IGF-1 treatment on autism-specific impairments in socialization, language, and repetitive behaviors. We expect to provide evidence for the safety and feasibility of IGF-1 in ameliorating social withdrawal in children with Autistic Disorder. Further, we expect to demonstrate that IGF-1 is associated with improvement on secondary outcomes of social impairment, language delay, and repetitive behavior, as well as on functional outcomes of global severity.
IGF-1 is an FDA approved, commercially available compound that crosses the blood-brain barrier and has beneficial effects on synaptic development by promoting neuronal cell survival, synaptic maturation, and synaptic plasticity. IGF-1 is effective in reversing mouse and neuronal models of Rett syndrome and Phelan McDermid syndrome, both single gene causes of ASD and may therefore be effective in treating autism spectrum disorders (ASD) more broadly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGF-1 | Experimental | Randomized, placebo-controlled, crossover format with 12 weeks in each treatment arm (IGF-1 and placebo), separated by a four-week wash-out phase. Dose titration will be initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Doses may be decreased according to tolerability by 0.04 mg/kg per dose. Medication will be administered twice daily with meals, and preprandial glucose monitoring will be performed by parents at treatment initiation, prior to each injection, and until a well tolerated dose is established. |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGF-1 | Drug | IGF-1 is an FDA-approved (IND exemption #113450), commercially available compound that crosses the blood-brain barrier and has beneficial effects on synaptic development by promoting neuronal cell survival, synaptic maturation, and synaptic plasticity. |
| Measure | Description | Time Frame |
|---|---|---|
| Aberrant Behavior Checklist - Social Withdrawal Subscale | Aberrant Behavior Checklist - Social Withdrawal Subscale has16 items, Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). Total Subscale scores range from 0 to 48. Higher score indicates poorer health outcomes. | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Kolevzon, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40351246 | Derived | Long J, Liao X, Han K, Niu M, Chen J, Wang X, Liu J, Zhang Y, Zhang H. Association of Thyroid Hormone and Insulin-Like Growth Factor-1 Levels With Autism Spectrum Disorders: A Systematic Review and Meta-Analysis. Autism Res. 2025 Jul;18(7):1497-1512. doi: 10.1002/aur.70052. Epub 2025 May 12. | |
| 37811711 | Derived |
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Decision made to terminate due to difficulty in procurement of adequate supply of treatment drug. Decision made on April 2023 to terminate study. However last participant visit was Sept 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | IGF-1 Then Placebo | Randomized, placebo-controlled, crossover format with 12 weeks in each treatment arm (IGF-1 and placebo), separated by a four-week wash-out phase. IGF-1: Dose titration initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Doses may be decreased according to tolerability by 0.04 mg/kg per dose. Medication will be administered twice daily with meals, and pre-prandial glucose monitoring will be performed by parents at treatment initiation, prior to each injection, and until a well-tolerated dose is established. Placebo: Matching Placebo |
| FG001 | Placebo Then IGF-1 | Randomized, placebo-controlled, crossover format with 12 weeks in each treatment arm (IGF-1 and placebo), separated by a four-week wash-out phase. IGF-1: Dose titration initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Doses may be decreased according to tolerability by 0.04 mg/kg per dose. Medication will be administered twice daily with meals, and pre-prandial glucose monitoring will be performed by parents at treatment initiation, prior to each injection, and until a well-tolerated dose is established. Placebo: Matching Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment Phase 12 Weeks |
|
| ||||||||||||||||||
| Crossover Washout Period 4 Weeks |
| |||||||||||||||||||
| Second Treatment Phase 12 Weeks |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Children With Autism Spectrum Disorders | Randomized, placebo-controlled, crossover format with 12 weeks in each treatment arm (IGF-1 and placebo), separated by a four-week wash-out phase. |
| 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 | Aberrant Behavior Checklist - Social Withdrawal Subscale | Aberrant Behavior Checklist - Social Withdrawal Subscale has16 items, Each item is scored as 0 (never a problem), 1 (slight problem), 2 (moderately serious problem), or 3 (severe problem). Total Subscale scores range from 0 to 48. Higher score indicates poorer health outcomes. | Results for participants who were still on study. | Posted | Mean | Standard Deviation | score on a scale | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
|
36 weeks
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IGF-1 | Dose titration will be initiated at 0.04 mg/kg twice daily by subcutaneous injection, and increased, as tolerated, every week by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Doses may be decreased according to tolerability by 0.04 mg/kg per dose. Medication will be administered twice daily with meals, and pre-prandial glucose monitoring will be performed by parents at treatment initiation, prior to each injection, and until a well-tolerated dose is established. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexander Kolevzon | Icahn School of Medicine at Mount Sinai | (212) 659-8762 | alexander.kolevzon@mssm.edu |
Not provided
| 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 | Oct 1, 2021 | Jun 16, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D007334 | Insulin-Like Growth Factor I |
| C000604197 | mecasermin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D013002 | Somatomedins |
| D000096764 | Insulin-Like Peptides |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo/saline | Drug | Placebo |
|
|
| Week 4 of Phase 1 |
| Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. | Week 12 of Phase 1 |
| Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. | Week 4 of Phase 2 |
| Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. | Week 8 of Phase 2 |
| Repetitive Behavior | Repetitive Behavior: Repetitive Behavior Scale (RBS) - Includes 43 items scored 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). Full scale from 0-129, with higher scores indicating worse outcomes. | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
| Caregiver Strain | Caregiver Strain Index - 21 question tool, with response 1 (not al all) - 5 (very much). Total score on scale from 21-105. Higher score indicates poorer health outcomes. | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
| Children's Yale-Brown Obsessive Compulsive Disorder Scale for Pervasive Developmental Disorders | Clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS-PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score 8 is considered clinically significant. | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
| The Clinical Global Impression - Severity Scale (CGI-S) | The CGI-S is a 7-point scale 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. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating. Full scale is 1 (normal, not at all ill) to 7 (extremely ill). | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
| Vineland Adaptive Behavior Composite Score | The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. | Baseline and Phase 1 Week 12 |
| 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. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo Placebo/saline: Placebo |
|
|
| Secondary | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. | Data provided for participants who completed week 4 | Posted | Mean | Standard Deviation | score on a scale | Week 4 of Phase 1 |
|
|
|
| Secondary | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. | Data provided for participants who completed week 12 | Posted | Mean | Standard Deviation | score on a scale | Week 12 of Phase 1 |
|
|
|
| Secondary | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. | Data provided for participants who completed week 4 | Posted | Mean | Standard Deviation | score on a scale | Week 4 of Phase 2 |
|
|
|
| Secondary | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) | Social Pervasive Developmental Disorder-Behavior Inventory (PDDBI) - Each item is marked as "0" (does not show the behavior), "1" (rarely shows the behavior), "2" (sometimes/partially shows the behavior), "3" (usually/typically shows the behavior), or "?" (uncertain/don't understand). The Sensory, Ritual, Social Pragmatic, Semantic Pragmatic, Arouse, Specific Fears, and Aggressiveness subscales range from 0 to 100, where higher score indicates worse severity than the average child with autism. The Social Approach, Expressive, and Learning Memory subscales range from 0 to 100, where higher score indicates better skills relative to the average child with autism. Scores reported in subscales. Scores were not reported as full scale. | Data provided for participants who completed week 8. Data not provided by participant for one subscale. | Posted | Mean | Standard Deviation | score on a scale | Week 8 of Phase 2 |
|
|
|
| Secondary | Repetitive Behavior | Repetitive Behavior: Repetitive Behavior Scale (RBS) - Includes 43 items scored 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). Full scale from 0-129, with higher scores indicating worse outcomes. | Data provided for participants who were on study | Posted | Mean | Standard Deviation | score on a scale | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
|
|
|
| Secondary | Caregiver Strain | Caregiver Strain Index - 21 question tool, with response 1 (not al all) - 5 (very much). Total score on scale from 21-105. Higher score indicates poorer health outcomes. | Data provided for participants who were on study | Posted | Mean | Standard Deviation | score on a scale | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
|
|
|
| Secondary | Children's Yale-Brown Obsessive Compulsive Disorder Scale for Pervasive Developmental Disorders | Clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS-PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score 8 is considered clinically significant. | data not collected | Posted | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
|
|
| Secondary | The Clinical Global Impression - Severity Scale (CGI-S) | The CGI-S is a 7-point scale 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. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating. Full scale is 1 (normal, not at all ill) to 7 (extremely ill). | Data provided for participants who were on study | Posted | Mean | Standard Deviation | score on a scale | Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8 |
|
|
|
| Secondary | Vineland Adaptive Behavior Composite Score | The Vineland Adaptive Behavior Scales, Second Edition (Survey Interview Form) yields an overall standard score (Adaptive Behavior Composite, ABC) and age standard scores in four domains. ABC scores have a mean of 100 and a standard deviation of 15 (range = 20 to 160). Higher scores suggest a higher level of adaptive functioning. | Data collected at baseline and Week 12 and only for participants on study. | Posted | Mean | Standard Deviation | T-score | Baseline and Phase 1 Week 12 |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | Placebo | Placebo/saline: Placebo | 0 | 2 | 0 | 2 | 2 | 2 |
| Sleep disturbance | General disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
| Bruising easily | Blood and lymphatic system disorders | Systematic Assessment |
|
| Increased energy | General disorders | Systematic Assessment |
|
| Aggression towards others | Psychiatric disorders | Systematic Assessment |
|
| oppositional behavior | Psychiatric disorders | Systematic Assessment |
|
| Eye blinking | Eye disorders | Systematic Assessment |
|
| Canker sore | General disorders | Systematic Assessment |
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| Enuresis | Renal and urinary disorders | Systematic Assessment |
|
| Vomiting/diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Congestion/allergies | General disorders | Systematic Assessment |
|
| Fever/congestion | General disorders | Systematic Assessment |
|
| Tic- head shake | Psychiatric disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Social Pragmatic |
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| Semantic Pragmatic |
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| Arouse |
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| Specific Fears |
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| Aggressiveness |
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| Social Approach |
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| Expressive |
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| Learning Memory |
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| Semantic Pragmatic |
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| Arouse |
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| Specific Fears |
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| Aggressiveness |
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| Social Approach |
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| Expressive |
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| Learning Memory |
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| Semantic Pragmatic |
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| Arouse |
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| Specific Fears |
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| Aggressiveness |
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| Social Approach |
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| Expressive |
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| Learning Memory |
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| Ritual |
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| Social Pragmatic |
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| Semantic Pragmatic |
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| Arouse |
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| Specific Fears |
|
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| Aggressiveness |
|
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| Social Approach |
|
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| Expressive |
|
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| Learning Memory |
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| Week 12 of Phase 1 |
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| Week 4 of Phase 2 |
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| Week 8 of Phase 2 |
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| Week 12, Phase 1 |
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| Week 4, Phase 2 |
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| Week 8, Phase 2 |
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| Week 12, Phase 1 |
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| Week 4, Phase 2 |
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| Week 8, Phase 2 |
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| Week 12, Phase 1 |
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