A Proof-of-Concept Study of Minocycline in Autism
NCT04031755 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2020-12-08
Summary
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.
Conditions
Interventions
- DRUG
-
Minocycline
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.
- DRUG
-
Placebos
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.
Sponsors & Collaborators
-
Children's Hospital Medical Center, Cincinnati
lead OTHER
Principal Investigators
-
Craig Erickson · Children's Hospital Medical Center, Cincinnati
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 12 Years
- Max Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-19
- Primary Completion
- 2020-10-30
- Completion
- 2020-10-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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