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The purpose of the study is to determine if Minocycline shows initial evidence of efficacy, safety, and tolerability in youth with Autism Spectrum Disorder ages 12 to 22 years.
This is a double-blind, placebo-controlled, crossover, proof-of-concept study that compares the pharmacodynamic and tolerability profiles of minocycline versus placebo in autism spectrum disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline versus Placebo | Experimental | Phase 1: 4 weeks of daily minocycline 100mg BID dosing 2-week washout period Phase 2: 4 weeks of daily placebo dosing |
|
| Placebo versus Minocycline | Experimental | Phase 1: 4 weeks of daily placebo dosing 2-week washout period Phase 2: 4 weeks of daily minocycline 100mg BID dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | Minocycline 100 mg capsules or matching placebo will be prepared by the central investigational pharmacy at Cincinnati Children's Hospital Medical Center. Drug identity will be masked by over encapsulation of the study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject weight will be compared pre- and post-treatment in the drug versus placebo conditions | Subject weight will be measured in kilograms | Through study completion, an average of 2 years |
| Aberrant Behavior will be evaluated pre- and post-treatment in the drug versus placebo conditions | Aberrant behavior will be measured by the Aberrant Behavior Checklist total score | Through study completion, an average of 2 years |
| Incidence of liver toxicity will be evaluated in the pre- and post-treatment setting in the drug versus placebo conditions | Liver toxicity will be defined as the development of an ALT or AST value greater than twice the upper limit of normal during a treatment period | Through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Erickson | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thompson Center for Autism & Neurodevelopmental Disorders - University of Missouri | Columbia | Missouri | 65211 | United States | ||
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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|
| Placebos | Drug | Minocycline 100 mg capsules or matching placebo will be prepared by the central investigational pharmacy at Cincinnati Children's Hospital Medical Center. Drug identity will be masked by over encapsulation of the study drug. |
|
| Cincinnati Children's Hospital Medical Center |
| Cincinnati |
| Ohio |
| 45229 |
| United States |
| Center for Autism and Developmental Disorders - University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15203 | United States |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |