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Minocycline to Treat Childhood Regressive Autism

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ClinicalTrials.gov Identifier: NCT00409747
Recruitment Status : Completed
First Posted : December 11, 2006
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Autism
Minocycline
Regressive Autism
Intervention Drug: Minocycline
Enrollment 11
Recruitment Details Referrals accepted from community physicians and self(parent) referrals.
Pre-assignment Details 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.
Arm/Group Title Minocycline
Hide Arm/Group Description Open-label minocycline treatment at 1.4 mg/kg/day
Period Title: Overall Study
Started 11
Completed 10
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Minocycline
Hide Arm/Group Description Open-label minocycline treatment at 1.4 mg/kg/day
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
10 subjects completed the trial and had analyzable data at the 6 month mark. One child had csf collected after 3 months.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
11
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
7.2  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
2
  18.2%
Male
9
  81.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title z Score
Hide Description

The Mann-Whitney U-test was used to compare pre-/post-treatment differences in analyte concentrations in serum, plasma and CSF. The Mann-Whitney U test generates a z-score test statistic with an associated p value. A negative z-statistic reflects a decrease in analyte level from pre- to post-treatment. Statistical significance level was set at 0.05. There is one test statistic (z-score) per analyte, reflecting the pre-post comparison across all subjects.

Pre and post treatment measurements of csf analytes: TNF alpha, Il-6, CCL-2(MCP-1), CCL3 (MIP-1alpha), CCL5(RANTES), CXCL(IL-8), BDNF, CD40L, GDNF, HGF, Leptin

Time Frame Pre and post treatment with minocyline at 6 months for 10 subjects
Hide Outcome Measure Data
Hide Analysis Population Description
10 subjects completed six months of minocycline and have pre-/post-minocycline CSF samples for analysis.
Arm/Group Title Minocycline
Hide Arm/Group Description:
Open-label minocycline treatment at 1.4 mg/kg/day
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Z-score
TNFalpha -0.45
IL-6 -0.36
CCL2(MCP-1) -1.78
CCL3(MIP-1alpha) -0.18
CCL5(Rantes) -0.73
CXCL8(IL-8) -0.45
BDNF -2.03
CD40L -0.89
GDNF -0.37
HGF -2.19
Leptin -1.48
2.Secondary Outcome
Title Clinical Global Impressions Scale-Severity (CGI). (Connors & Barkley, 1985)
Hide Description This instrument has two scales - Severity (CGI-S). The CGI-S is a seven point scale with a minimum score of 1 and a maximum score as 7 as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All children completing 6 months of drug and participating in final evaluation
Arm/Group Title Minocycline
Hide Arm/Group Description:
Open-label minocycline treatment at 1.4 mg/kg/day
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mean scores on global impression scale
Baseline 4.4  (0.8)
6 months 4.6  (.81)
Time Frame 6 months of minocycline administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study/Minocycline
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Overall Study/Minocycline
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Overall Study/Minocycline
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study/Minocycline
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
Gastrointestinal disorders   
Vomiting and fever  [1]  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Related to intercurrent illness
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Susan Swedo
Organization: NIH/NIMH/PDN Branch
Phone: 301-496-5323
EMail: swedos@mail.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00409747    
Other Study ID Numbers: 070024
07-M-0024 ( Other Identifier: NIH Protocol number )
First Submitted: December 8, 2006
First Posted: December 11, 2006
Results First Submitted: October 22, 2012
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015