Trial · NCT01053156

Trial of Minocycline to Treat Children With Fragile X Syndrome

NCT01053156, Not applicable, Completed, University of California, Davis; results first posted 2014-07-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Minocycline to Treat Children With Fragile X Syndrome. Trials, record NCT01053156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01053156

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Minocycline to Treat Children With Fragile X Syndrome
NCT number: NCT01053156
Status: Completed
Phases: Not applicable
Enrollment: 66 participants, actual
Lead sponsor: University of California, Davis
Conditions: Fragile X Syndrome
Interventions: minocycline hydrochloride, Placebo
First posted: 2010-01-21
Last updated: 2017-05-30
Results first posted: 2014-07-30
Limitations and caveats: Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators.

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Clinical Global Impression Scale (CGI)	3 months (post first treatment) and 6 months (post second treatment)	The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 "very much improved" to 7 "very much worse". Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner.
Primary	Visual Analogue Scale- Behavior 1	Baseline, 3 months, 6 months	A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the first behavior that the caregivers noted, out of three.
Secondary	Visual Analogue Scale- Behaviors 2	Baseline, 3 months, 6 months	A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the second behavior that the caregivers noted, out of three.
Secondary	Expressive Vocabulary Test-2	Baseline, 3 months and 6 months	The EVT-2 standard score assesses language development through a participant's one word synonym response to visual stimuli. Standard scores range from 20-160. A standard score of 100 is average, with a 15 point standard deviation. Higher values represent a better outcome.
Secondary	Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score	Baseline, 3 months, and 6 months	The VABS-II Adaptive Behavior Composite Score was used to assess adaptive skills. An Adaptive Behavior Composite Score may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.
Secondary	Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score	Baseline, 3 months, and 6 months	The ABC-C composite scores were used to quantify the severity of a patient's behaviors. A composite score consists of subscale scores including Irritability and Agitation, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity and Noncompliance, and Inappropriate Speech. The composite score may range from 0-174. Lower scores indicate improvement.
Secondary	Visual Analogue Scale Behavior 3- VAS3	Baseline, 3 months, 6 months	A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the third behavior that caregivers noted, out of three.
Secondary	VAS Categorized by Behavior: Aggression/ ADHD	Baseline, 3 months, 6 months	A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with aggression or ADHD behaviors.
Secondary	VAS Categorized by Behavior:Anxiety/ Mood	Baseline, 3 months, 6 months	A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with anxiety or mood related behaviors.
Secondary	VAS Categorized by Behavior:Language/ Cognition	Baseline, 3 months, 6 months	A VAS is used to represent a caregiver's assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with language or cognitive symptoms.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Clinical Global Impression Scale (CGI)	3 months (post first treatment) and 6 months (post second treatment)	Any participant who completed at least the first arm of the trial were included in the intention to treat analysis	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Visual Analogue Scale- Behavior 1	Baseline, 3 months, 6 months	Any participant who completed at least the first arm of the trial were included in the intention to treat analysis	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Visual Analogue Scale- Behaviors 2	Baseline, 3 months, 6 months		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Expressive Vocabulary Test-2	Baseline, 3 months and 6 months		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score	Baseline, 3 months, and 6 months		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score	Baseline, 3 months, and 6 months		units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Visual Analogue Scale Behavior 3- VAS3	Baseline, 3 months, 6 months	This behavior was not provided by all of the participating caregivers, and so the number is less than the participants analyzed for other measures.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	VAS Categorized by Behavior: Aggression/ ADHD	Baseline, 3 months, 6 months	In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding ADHD or Aggression symptoms were placed into this category. As not every caregiver named a behavior related to ADHD or aggression, this number is less than the number of participants.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	VAS Categorized by Behavior:Anxiety/ Mood	Baseline, 3 months, 6 months	In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding anxiety or mood symptoms were placed into this category. As not every caregiver named a behavior related to anxiety or mood, this number is less than the number of participants.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	VAS Categorized by Behavior:Language/ Cognition	Baseline, 3 months, 6 months	In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding language or cognition symptoms were placed into this category. As not every caregiver named a behavior related to language or cognition, this number is less than the number of participants.	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Clinical Global Impression Scale (CGI)	Minocycline	2.49	Standard Error 0.13	units on a scale
Clinical Global Impression Scale (CGI)	Placebo	2.97	Standard Error 0.13	units on a scale
Visual Analogue Scale- Behavior 1	Baseline	2.28	Standard Error 0.21	units on a scale
Visual Analogue Scale- Behavior 1	Minocycline	4.60	Standard Error 0.31	units on a scale
Visual Analogue Scale- Behavior 1	Placebo	4.44	Standard Error 0.30	units on a scale
Visual Analogue Scale- Behaviors 2	Baseline	2.62	Standard Error 0.23	units on a scale
Visual Analogue Scale- Behaviors 2	Minocycline	4.91	Standard Error 0.31	units on a scale
Visual Analogue Scale- Behaviors 2	Placebo	4.16	Standard Error 0.29	units on a scale
Expressive Vocabulary Test-2	Baseline	65.92	Standard Error 3.61	units on a scale
Expressive Vocabulary Test-2	Minocycline	68.86	Standard Error 1.28	units on a scale

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (Week 1-12)	STARTED	Minocycline First, Then Placebo Second	33
First Intervention (Week 1-12)	STARTED	Placebo First, Minocycline Second	33
First Intervention (Week 1-12)	COMPLETED	Minocycline First, Then Placebo Second	28
First Intervention (Week 1-12)	COMPLETED	Placebo First, Minocycline Second	27
First Intervention (Week 1-12)	NOT COMPLETED	Minocycline First, Then Placebo Second	5
First Intervention (Week 1-12)	NOT COMPLETED	Placebo First, Minocycline Second	6
Second Intervention (Week 13-24)	STARTED	Minocycline First, Then Placebo Second	28
Second Intervention (Week 13-24)	STARTED	Placebo First, Minocycline Second	27
Second Intervention (Week 13-24)	COMPLETED	Minocycline First, Then Placebo Second	26
Second Intervention (Week 13-24)	COMPLETED	Placebo First, Minocycline Second	22

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhea	Gastrointestinal disorders	Minocycline	15	66	15
other	Diarrhea	Gastrointestinal disorders	Placebo	15	66	15
other	GI Upset/ Vomiting/Loss of Appetite	Gastrointestinal disorders	Minocycline	9	66	9
other	GI Upset/ Vomiting/Loss of Appetite	Gastrointestinal disorders	Placebo	15	66	15
other	Skin Rash/ Itching/ Swelling	Skin and subcutaneous tissue disorders	Minocycline	12	66	12
other	Skin Rash/ Itching/ Swelling	Skin and subcutaneous tissue disorders	Placebo	7	66	7
other	Fever/Chills/URI/Sore Throat	Respiratory, thoracic and mediastinal disorders	Minocycline	6	66	6
other	Fever/Chills/URI/Sore Throat	Respiratory, thoracic and mediastinal disorders	Placebo	11	66	11
other	Headache	Nervous system disorders	Minocycline	4	66	4
other	Headache	Nervous system disorders	Placebo	5	66	5

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Minocycline
Total, all-cause mortality	Placebo
Total, other adverse events	Minocycline	53	66
Total, other adverse events	Placebo	53	66
Total, serious adverse events	Minocycline	0	66
Total, serious adverse events	Placebo	1	66

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
18835858	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Minocycline vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants