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Trial record 1 of 1 for:    NCT04031755
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A Proof-of-Concept Study of Minocycline in Autism

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ClinicalTrials.gov Identifier: NCT04031755
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Drug: Minocycline Drug: Placebos Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Pharmacodynamic and Tolerability Profiles of Minocycline Versus Placebo in Autism Spectrum Disorder: a Double-blind, Placebo-controlled, Crossover, Proof-of-concept Study
Actual Study Start Date : April 19, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Minocycline versus Placebo

Phase 1: 4 weeks of daily minocycline 100mg BID dosing

2-week washout period

Phase 2: 4 weeks of daily placebo dosing

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.

Experimental: Placebo versus Minocycline

Phase 1: 4 weeks of daily placebo dosing

2-week washout period

Phase 2: 4 weeks of daily minocycline 100mg BID dosing

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.




Primary Outcome Measures :
  1. Subject weight will be compared pre- and post-treatment in the drug versus placebo conditions [ Time Frame: Through study completion, an average of 2 years ]
    Subject weight will be measured in kilograms

  2. Aberrant Behavior will be evaluated pre- and post-treatment in the drug versus placebo conditions [ Time Frame: Through study completion, an average of 2 years ]
    Aberrant behavior will be measured by the Aberrant Behavior Checklist total score

  3. Incidence of liver toxicity will be evaluated in the pre- and post-treatment setting in the drug versus placebo conditions [ Time Frame: Through study completion, an average of 2 years ]
    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



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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 22 ≥ Age ≥12 years. Males and females included in study.
  2. Diagnostic confirmation of Autism Spectrum Disorder as confirmed by gold standard clinical interview using DSM 5 criteria and administration of the Autism Diagnostic Observation Schedule-2, Module 3 or 4.
  3. General good health as determined by physical exam, medical and psychiatric history and safety labs as defined by the PI or designee.
  4. Male study participants who are sexually active with a female partner of childbearing potential must be surgically sterilized, practicing abstinence, or agree to use highly effective methods of birth control (defined below), and not rely on barrier methods and spermicide alone, from the time of screening until 1 week after final dose of study drug.
  5. Female participants of childbearing potential may be included in the study provided they are practicing abstinence or are using a double barrier method from the time of screening until 1 week after the final dose of study drug. Participants using hormonal methods of birth control (oral, intravaginal, transdermal, injectable, or implantable) must be on a stable dose for at least three months prior to screening.
  6. Whole brain absolute cumulative gamma power (30 to 80 Hz) with median cut off at 2.5 (upward adjusted)

Exclusion Criteria:

  1. Allergy or hypersensitivity to any of the tetracyclines antibiotics.
  2. Inability to swallow study drug.
  3. Concomitant use of scheduled anti-inflammatory drugs with the exception of as needed ibuprofen or acetaminophen use.
  4. Unstable dosing of any mood, anxiety or behavior medications in the 5 half-lives prior to Phase 1 baseline visit.
  5. Concomitant use of scheduled benzodiazepines, baclofen, gabapentin, pregabalin, or supplements with impact on the GABA system.
  6. Concomitant daily use of antacids
  7. Concomitant use of oral acne medications (isotretinoin), not including lotions or creams applied to the skin
  8. Concomitant use of any cannabinoid or related product.
  9. Unstable seizure disorder as defined by any seizure in the 6 months prior to baseline visit and/or a change in any anti-convulsant drug dosing in the 60 days prior to study screen.
  10. Abnormal baseline safety lab assessments including, but not limited to ALT or AST greater than 1.5x the upper limit of normal, elevated ANA, total bilirubin or creatinine greater than 1x the upper limit of normal, other clinically relevant lab abnormality, or abnormality in ECG, HR or BP at screening as determined by the investigator or designee.
  11. History of autoimmune disorder
  12. History of or current abuse of drugs or alcohol including prescription medication.
  13. Women who are pregnant (i.e. have a positive pregnancy test), intending to become pregnant, breast feeding, or women of child-bearing potential who are unwilling to use contraception as required in the study inclusion criteria or maintain abstinence during the course of the study
  14. Inability to attend scheduled study visits, plans for family relocation during the study, or any other criteria that the investigator may determine to be associated with inability to complete the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031755


Contacts
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Contact: Study Coordinator 513-636-0523 autism@cchmc.org

Locations
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United States, Missouri
Thompson Center for Autism & Neurodevelopmental Disorders - University of Missouri Recruiting
Columbia, Missouri, United States, 65211
Contact: Study Coordinator    573-303-8405    tcresearch@missouri.edu   
Principal Investigator: David Beversdorf         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Study Coordinator    513-636-0523    autism@cchmc.org   
Principal Investigator: Craig Erickson         
United States, Pennsylvania
Center for Autism and Developmental Disorders - University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15203
Contact: Study Coordinator    412-235-5447    mcausj@upmc.edu   
Principal Investigator: Benjamin Handen         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Craig Erickson Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04031755    
Other Study ID Numbers: CIN001 - Minocycline in ASD
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Autism
Autism Spectrum Disorder
Minocycline
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents