Trial record 1 of 4 for: minocycline and autism

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Minocycline to Treat Childhood Regressive Autism

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

ClinicalTrials.gov Identifier:

NCT00409747

First received: December 8, 2006

Last updated: November 5, 2015

Last verified: November 2015

History of Changes

Results First Received: October 22, 2012

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Autism Minocycline Regressive Autism
Intervention:	Drug: Minocycline

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Referrals accepted from community physicians and self(parent) referrals.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three subjects did not start the drug due to abnormal MRI,initial elevated liver enzymes, and and initial elevated amylase. 11 subjects began taking drug. One subject withdrew after starting drug.

Reporting Groups

	Description
Minocycline	Open-label minocycline treatment at 1.4 mg/kg/day

Participant Flow: Overall Study

	Minocycline
STARTED	11
COMPLETED	10
NOT COMPLETED	1
Withdrawal by Subject	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
10 subjects completed the trial and had analyzable data at the 6 month mark. One child had csf collected after 3 months.

Reporting Groups

	Description
Minocycline	Open-label minocycline treatment at 1.4 mg/kg/day

Baseline Measures

	Minocycline
Overall Participants Analyzed [Units: Participants]	11

Age [Units: Participants]
<=18 years	11
Between 18 and 65 years	0
>=65 years	0

Age [Units: Years] Mean (Standard Deviation)	7.2 (2.9)

Gender [Units: Participants]
Female	2
Male	9

Region of Enrollment [Units: Participants]
United States	11

Outcome Measures

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1. Primary:

z Score [ Time Frame: Pre and post treatment with minocyline at 6 months for 10 subjects ]

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2. Secondary:

Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985) [ Time Frame: Baseline and 6 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small, uncontrolled pilot.

More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Susan Swedo
Organization: NIH/NIMH/PDN Branch
phone: 301-496-5323
e-mail: swedos@mail.nih.gov

Publications:

Auld DS, Robitaille R. Glial cells and neurotransmission: an inclusive view of synaptic function. Neuron. 2003 Oct 9;40(2):389-400. Review.

Aman MG, Singh NN, Stewart AW, Field CJ. The aberrant behavior checklist: a behavior rating scale for the assessment of treatment effects. Am J Ment Defic. 1985 Mar;89(5):485-91.

Barger SW, Moerman AM, Mao X. Molecular mechanisms of cytokine-induced neuroprotection: NFkappaB and neuroplasticity. Curr Pharm Des. 2005;11(8):985-98. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lane R, Kessler R, Buckley AW, Rodriguez A, Farmer C, Thurm A, Swedo S, Felt B. Evaluation of Periodic Limb Movements in Sleep and Iron Status in Children With Autism. Pediatr Neurol. 2015 Oct;53(4):343-9. doi: 10.1016/j.pediatrneurol.2015.06.014. Epub 2015 Jun 26.

Pardo CA, Buckley A, Thurm A, Lee LC, Azhagiri A, Neville DM, Swedo SE. A pilot open-label trial of minocycline in patients with autism and regressive features. J Neurodev Disord. 2013;5(1):9. doi: 10.1186/1866-1955-5-9. Epub 2013 Apr 8.

Responsible Party:	National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:	NCT00409747 History of Changes
Other Study ID Numbers:	070024 07-M-0024 ( Other Identifier: NIH Protocol number )
Study First Received:	December 8, 2006
Results First Received:	October 22, 2012
Last Updated:	November 5, 2015

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