Trial · NCT02998151

Neurophysiological and Acute Pharmacological Studies in FXS Patients

NCT02998151, Early phase 1, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2021-11-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Neurophysiological and Acute Pharmacological Studies in FXS Patients. Trials, record NCT02998151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02998151

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Trial

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

Title: Neurophysiological and Acute Pharmacological Studies in FXS Patients
NCT number: NCT02998151
Status: Completed
Phases: Early phase 1
Enrollment: 29 participants, actual
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Fragile X Syndrome
Interventions: Acamprosate, Lovastatin, Minocycline, Placebo, Baclofen
First posted: 2016-12-20
Last updated: 2021-11-26
Results first posted: 2021-11-24

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change in EEG Relative Gamma Power	Pre-dose, 4-hour post-dose	EEG relative gamma power at rest was calculated as the percent of power in the gamma frequencies relative to the sum of power in all frequency bands, averaged across electrodes, and calculated separately at pre-dose and post-dose timepoints. To assess the impact of drug, the pre-dose relative gamma power was subtracted from post-dose relative gamma power. Higher numbers indicate more relative gamma power post-dose; lower numbers indicate more relative gamma power pre-dose.
Primary	Clinical Global Impressions-Improvement	4-hour post-dose	The Clinical Global Impressions - Improvement (CGI-I) requires the clinician to assess how much the patient's illness has changed relative to pre-dose, from 1 (very much improved) to 7 (very much worse).
Secondary	Woodcock Johnson Test of Cognitive Abilities - Auditory Attention Task	4-hour post-dose	Woodcock Johnson Test of Cognitive Abilities III Auditory Attention subscale. Participants must identify orally presented words amid increasingly intense background noise. The scores for this subtask range from 0-50, with higher scores indicating a better outcome. Raw scores for this subscale are reported (rather than standard scores, or age- or grade-equivalents).
Secondary	Change From Pre-dose in the Repeatable Battery for the Assessment of Neuropsychological Status at 4 Hours Post Dose	Pre-dose, 4-hour post dose	Four 10-item lists of unrelated words were presented orally to the examinee who was then required to immediately recall words presented, at both pre-dose and post-dose timepoints. The impact of drug was assessed by subtracting the number of words remembered post-dose from the number of words remembered pre-dose. Lower numbers indicate more words remembered post-dose; higher numbers indicate more words remembered pre-dose.
Secondary	Test of Attentional Performance for Children (KiTAP) Test of Alertness	Predose, 4-hour post-dose	Computerized task where an examinee is required to push a key when a target stimulus is presented on the screen. Scores are presented as change in median reaction time (RT), in milliseconds.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in EEG Relative Gamma Power	Pre-dose, 4-hour post-dose	Missing 1 placebo, 1 lovastatin who contributed data with excessive movement or other artifact, or were unable to complete the task.	percent of power in gamma frequencies	MEAN
PRIMARY	Clinical Global Impressions-Improvement	4-hour post-dose	CGI-I was not collected for one participant on their minocycline day and another participant on their baclofen day.	score on a scale	MEAN
SECONDARY	Woodcock Johnson Test of Cognitive Abilities - Auditory Attention Task	4-hour post-dose	Data is missing from 2 placebo, 1 acamprosate, 1 lovastatin, 2 minocycline, and 1 baclofen.	score on a scale	MEAN
SECONDARY	Change From Pre-dose in the Repeatable Battery for the Assessment of Neuropsychological Status at 4 Hours Post Dose	Pre-dose, 4-hour post dose	One participant is missing from placebo, acamprosate, lovastatin, and minocycline conditions due to being unable to repeat list words back to experimenter (nonverbal). Baclofen and placebo are each additionally missing one participant who did not complete the pre-dose or post-dose task.	number of words remembered	MEAN
SECONDARY	Test of Attentional Performance for Children (KiTAP) Test of Alertness	Predose, 4-hour post-dose	One participant is missing from the placebo, acamprosate, lovastatin, and minocycline conditions due to being unable to participate in the task. An additional one participant each is missing from placebo, acamprosate, and lovastatin conditions due to uncollected data at either the pre-dose or post-dose timepoint.	change in median RT in milliseconds	MEAN

Source ClinicalTrials.gov

Results by group25

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

Outcome	Group	Value	Spread	Units
Change in EEG Relative Gamma Power	Placebo	0.0024	Standard Deviation .0265	percent of power in gamma frequencies
Change in EEG Relative Gamma Power	Acamprosate	-0.0077	Standard Deviation 0.0252	percent of power in gamma frequencies
Change in EEG Relative Gamma Power	Lovastatin	-0.0039	Standard Deviation 0.0225	percent of power in gamma frequencies
Change in EEG Relative Gamma Power	Minocycline	0.0019	Standard Deviation 0.0235	percent of power in gamma frequencies
Change in EEG Relative Gamma Power	Baclofen	-0.0160	Standard Deviation 0.0346	percent of power in gamma frequencies
Clinical Global Impressions-Improvement	Placebo	3.70	Standard Deviation .61	score on a scale
Clinical Global Impressions-Improvement	Acamprosate	3.88	Standard Deviation .62	score on a scale
Clinical Global Impressions-Improvement	Lovastatin	3.97	Standard Deviation .50	score on a scale
Clinical Global Impressions-Improvement	Minocycline	3.81	Standard Deviation .49	score on a scale
Clinical Global Impressions-Improvement	Baclofen	3.94	Standard Deviation .43	score on a scale

1 to 10 of 25Source ClinicalTrials.gov

See all 25 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	All Study Participants	29
Overall Study	Placebo	All Study Participants	27
Overall Study	Acamprosate	All Study Participants	16
Overall Study	Lovastatin	All Study Participants	29
Overall Study	Minocycline	All Study Participants	27
Overall Study	Baclofen	All Study Participants	18
Overall Study	COMPLETED	All Study Participants	5
Overall Study	NOT COMPLETED	All Study Participants	24

Source ClinicalTrials.gov

Adverse events60

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	Nausea	Gastrointestinal disorders	Placebo	0	27	0
other	Nausea	Gastrointestinal disorders	Acamprosate	0	16	0
other	Nausea	Gastrointestinal disorders	Lovastatin	0	29	0
other	Nausea	Gastrointestinal disorders	Minocycline	0	27	0
other	Nausea	Gastrointestinal disorders	Baclofen	1	18	1
other	Stomach pain	Gastrointestinal disorders	Placebo	1	27	1
other	Stomach pain	Gastrointestinal disorders	Acamprosate	1	16	1
other	Stomach pain	Gastrointestinal disorders	Lovastatin	1	29	1
other	Stomach pain	Gastrointestinal disorders	Minocycline	2	27	2
other	Stomach pain	Gastrointestinal disorders	Baclofen	0	18	0

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	27
Total, all-cause mortality	Acamprosate	0	16
Total, all-cause mortality	Lovastatin	0	29
Total, all-cause mortality	Minocycline	0	27
Total, all-cause mortality	Baclofen	0	18
Total, other adverse events	Placebo	3	27
Total, other adverse events	Acamprosate	7	16
Total, other adverse events	Lovastatin	4	29
Total, other adverse events	Minocycline	4	27
Total, other adverse events	Baclofen	4	18

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36167501	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U54HD082008	Mechanisms of neocortical and sensory hyperexcitability in Fragile X Syndrome	HUBER, KIMBERLY M.	UT SOUTHWESTERN MEDICAL CENTER	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2014 to 2019

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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.

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