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
Results First Received: October 22, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   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  
Number of Participants  
[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 ]

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


  Serious Adverse Events


  Other Adverse Events


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

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
Health Authority: United States: Federal Government