Trial · NCT05030129

ERG/5-HTP in Fragile X Syndrome (FXS)

NCT05030129, Phase 2, Completed, Elizabeth Berry-Kravis; results first posted 2024-09-19

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. ERG/5-HTP in Fragile X Syndrome (FXS). Trials, record NCT05030129. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05030129

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Trial

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

Title: ERG/5-HTP in Fragile X Syndrome (FXS)
NCT number: NCT05030129
Status: Completed
Phases: Phase 2
Enrollment: 15 participants, actual
Lead sponsor: Elizabeth Berry-Kravis
Conditions: Fragile X Syndrome
Interventions: 5-Hydroxytryptophan, Ergoloid Mesylates, Matching placebo for Ergoloid mesylates, Matching placebo for 5-Hydroxytryptophan
First posted: 2021-09-01
Last updated: 2024-09-19
Results first posted: 2024-09-19

Source ClinicalTrials.gov

Registered outcomes18

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

List	Outcome	Time frame	Description
Primary	Safety and Tolerability - Number of Treatment-Emergent Adverse Events	Baseline through Week 17	Adverse Events (AEs), including clinically meaningful laboratory abnormalities and significant behavioral changes will be recorded from the time of the subject's first dose of study drug to the end of the study (Week 17) or longer if needed. Adverse events will be assessed at each visit as well as during each phone call and will be tabulated for each treatment period.
Primary	Safety and Tolerability - Severity of Treatment Emergent Adverse Events	Baseline through Week 17	Adverse Events (AEs), including clinically meaningful laboratory abnormalities and significant behavioral changes will be tabulated for each treatment period. The Investigator is responsible for assessing the severity (intensity) of each adverse event as mild, moderate, or severe according to the following definitions: Mild - An event that is easily tolerated and generally not interfering with normal daily activities. Moderate - An event that is sufficiently discomforting to interfere with normal daily activities. Severe - An event that is incapacitating with inability to work or perform normal daily activities.
Secondary	Change From Baseline in KiTAP Executive Battery - Alertness Subscore (Reaction Time)	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning. The alertness subtest requires subjects to tap a button every time a stimulus appears on the screen. KiTAP was completed at Baseline as well as Week 4, Week 8, Week 12, and Week 16 (the end of each treatment period). Mean reaction time was measured over 90 seconds and change from baseline was calculated. A lower reaction time (net decrease in reaction time) indicates better performance.
Secondary	Change From Baseline in Total Number of Correct Responses on KiTAP Executive Battery Distractibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning. The distractibility subtest measures how easily the subject is distracted by extraneous stimuli. This subtest requires subjects to tap a button when a target stimulus appears on the screen while ignoring distracters that appear shortly before the stimulus. KiTAP was completed at Baseline as well as Week 4, Week 8, Week 12, and Week 16 (the end of each treatment period). Mean number of correct responses and errors were recorded, and change from baseline was calculated. For the distractability subtest, a higher mean number of correct responses and lower mean number of errors over the 3 minutes indicates better performance.
Secondary	Change From Baseline in Total Number of Errors on KiTAP Executive Battery Distractibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning. The distractibility subtest measures how easily the subject is distracted by extraneous stimuli. This subtest requires subjects to tap a button when a target stimulus appears on the screen while ignoring distracters that appear shortly before the stimulus. KiTAP was completed at Baseline as well as Week 4, Week 8, Week 12, and Week 16 (the end of each treatment period). Mean number of correct responses and errors were recorded, and change from baseline was calculated. For the distractability subtest, a higher mean number of correct responses and lower mean number of errors over the 3 minutes indicates better performance.
Secondary	Change From Baseline in Total Number of Correct Responses on KiTAP Executive Battery Flexibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning. The flexibility subtest measures the subject's ability to be flexible about shifting from one response type to another. This subtest is 2 minutes long and requires subjects to alternate between identifying blue and green dragons which seem on random sides of the screen by tapping one of two buttons. KiTAP was completed at Baseline as well as Week 4, Week 8, Week 12, and Week 16 (the end of each treatment period). Mean number of correct responses and errors were recorded and change from baseline was calculated. For the flexibility subtest, a higher mean number of correct responses and lower mean number of errors indicates better performance.
Secondary	Change From Baseline in Total Number of Errors on KiTAP Executive Battery Flexibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning. The flexibility subtest measures the subject's ability to be flexible about shifting from one response type to another. This subtest is 2 minutes long and requires subjects to alternate between identifying blue and green dragons which seem on random sides of the screen by tapping one of two buttons. KiTAP was completed at Baseline as well as Week 4, Week 8, Week 12, and Week 16 (the end of each treatment period). Mean number of correct responses and errors were recorded and change from baseline was calculated. For the flexibility subtest, a higher mean number of correct responses and lower mean number of errors indicates better performance.
Secondary	Change From Baseline in Total Number of Correct Responses on KiTAP Test of Attentional Performance Go-NoGo Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning. The Go-NoGo subtest measures a subject's impulsivity by requiring subjects to tap a button when the target stimulus is presented, while refraining from hitting the button for the non-target stimulus. KiTAP was completed at Baseline as well as Week 4, Week 8, Week 12, and Week 16 (the end of each treatment period). This subtest takes place over 2 minutes 30 seconds. Mean number of correct responses and errors were recorded, and change from baseline was calculated. For the Go-NoGo subtest, a higher mean number of correct responses and a lower mean number of errors indicates better performance.
Secondary	Change From Baseline in Total Number of Errors on KiTAP Test of Attentional Performance Go-NoGo Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The KiTAP is a computerized executive function battery that consists of eight nonverbal subtests measuring different basal as well as higher-order components of attention and executive functioning. The Go-NoGo subtest measures a subject's impulsivity by requiring subjects to tap a button when the target stimulus is presented, while refraining from hitting the button for the non-target stimulus. KiTAP was completed at Baseline as well as Week 4, Week 8, Week 12, and Week 16 (the end of each treatment period). This subtest takes place over 2 minutes 30 seconds. Mean number of correct responses and errors were recorded, and change from baseline was calculated. For the Go-NoGo subtest, a higher mean number of correct responses and a lower mean number of errors indicates better performance.
Secondary	Change From Baseline in Clinical Global Impression Severity Scale Overall Score	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The Clinical Global Impression-Severity (CGI-S) is a global measure to provide a clinical judgment of a participant's overall condition based on a trained clinician's assessment of cognition, behavior and activities of daily living. The clinician compares the subject with individuals of the same age and sex. The assessment of severity is with a 7-point scale: 1, not ill; 2, very mild; 3, mild; 4, moderate; 5, marked; 6, severe; 7, extremely severe. A net decrease in severity score over time indicates a positive outcome.

1 to 10 of 18Source ClinicalTrials.gov

See all 18 registered outcomes

Outcomes18

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Safety and Tolerability - Number of Treatment-Emergent Adverse Events	Baseline through Week 17	The Safety population will include all participants who received at least one dose of study treatment.	Number of Adverse Events	NUMBER
PRIMARY	Safety and Tolerability - Severity of Treatment Emergent Adverse Events	Baseline through Week 17	The Safety population will include all participants who received at least one dose of study treatment.	Number of Adverse Events	NUMBER
SECONDARY	Change From Baseline in KiTAP Executive Battery - Alertness Subscore (Reaction Time)	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit.	milliseconds	MEAN
SECONDARY	Change From Baseline in Total Number of Correct Responses on KiTAP Executive Battery Distractibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	Intent to treat (ITT) efficacy population, which includes all participants who received at least one dose of treatment and returned for at least one follow-up visit.	Correct Responses	MEAN
SECONDARY	Change From Baseline in Total Number of Errors on KiTAP Executive Battery Distractibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	Intent to treat (ITT) efficacy population, which includes all participants who received at least one dose of treatment and returned for at least one follow-up visit.	Errors	MEAN
SECONDARY	Change From Baseline in Total Number of Correct Responses on KiTAP Executive Battery Flexibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit.	Correct Responses	MEAN
SECONDARY	Change From Baseline in Total Number of Errors on KiTAP Executive Battery Flexibility Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit.	Errors	MEAN
SECONDARY	Change From Baseline in Total Number of Correct Responses on KiTAP Test of Attentional Performance Go-NoGo Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The primary efficacy population will be the intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit.	Correct Responses	MEAN
SECONDARY	Change From Baseline in Total Number of Errors on KiTAP Test of Attentional Performance Go-NoGo Subtest	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	The primary efficacy population will be the intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit.	Errors	MEAN
SECONDARY	Change From Baseline in Clinical Global Impression Severity Scale Overall Score	Baseline, Week 4 (EM Treatment), Week 8 (EM+5-HTP Treatment), Week 12 (5-HTP Treatment), Week 16 (Placebo Treatment)	Intent to treat (ITT) efficacy population, which will include all participants who received at least one dose of treatment and returned for at least one follow-up visit.	scores on a scale	MEAN

1 to 10 of 18Source ClinicalTrials.gov

See all 18 outcomes

Results by group164

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

Outcome	Group	Category	Value	Units
Safety and Tolerability - Number of Treatment-Emergent Adverse Events	Ergoloid Mesylates (EM)		2	Number of Adverse Events
Safety and Tolerability - Number of Treatment-Emergent Adverse Events	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)		1	Number of Adverse Events
Safety and Tolerability - Number of Treatment-Emergent Adverse Events	5-hydroxytryptophan (5-HTP)		1	Number of Adverse Events
Safety and Tolerability - Number of Treatment-Emergent Adverse Events	Placebo		3	Number of Adverse Events
Safety and Tolerability - Severity of Treatment Emergent Adverse Events	Ergoloid Mesylates (EM)	Mild	2	Number of Adverse Events
Safety and Tolerability - Severity of Treatment Emergent Adverse Events	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	Mild	1	Number of Adverse Events
Safety and Tolerability - Severity of Treatment Emergent Adverse Events	5-hydroxytryptophan (5-HTP)	Mild	1	Number of Adverse Events
Safety and Tolerability - Severity of Treatment Emergent Adverse Events	Placebo	Mild	2	Number of Adverse Events
Safety and Tolerability - Severity of Treatment Emergent Adverse Events	Ergoloid Mesylates (EM)	Moderate	0	Number of Adverse Events
Safety and Tolerability - Severity of Treatment Emergent Adverse Events	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	Moderate	0	Number of Adverse Events

1 to 10 of 164Source ClinicalTrials.gov

See all 164 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Screening Period	STARTED	Adult Males With Fragile X Syndrome	15
Screening Period	COMPLETED	Adult Males With Fragile X Syndrome	15
Screening Period	NOT COMPLETED	Adult Males With Fragile X Syndrome	0
Treatment Period 1: EM & Placebo	STARTED	Adult Males With Fragile X Syndrome	15
Treatment Period 1: EM & Placebo	COMPLETED	Adult Males With Fragile X Syndrome	15
Treatment Period 1: EM & Placebo	NOT COMPLETED	Adult Males With Fragile X Syndrome	0
Treatment Period 2: EM & 5-HTP	STARTED	Adult Males With Fragile X Syndrome	15
Treatment Period 2: EM & 5-HTP	COMPLETED	Adult Males With Fragile X Syndrome	15
Treatment Period 2: EM & 5-HTP	NOT COMPLETED	Adult Males With Fragile X Syndrome	0
Treatment Period 3: 5-HTP & Placebo	STARTED	Adult Males With Fragile X Syndrome	15

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events28

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	Increased Irritability	Psychiatric disorders	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	0	15	0
other	Increased Irritability	Psychiatric disorders	Placebo	2	15	2
other	Increased Irritability	Psychiatric disorders	Ergoloid Mesylates (EM) and Placebo	0	15	0
other	Increased Irritability	Psychiatric disorders	5-hydroxytryptophan (5-HTP) and Placebo	0	15	0
other	Diarrhea	Gastrointestinal disorders	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	1	15	1
other	Diarrhea	Gastrointestinal disorders	Placebo	0	15	0
other	Diarrhea	Gastrointestinal disorders	Ergoloid Mesylates (EM) and Placebo	0	15	0
other	Diarrhea	Gastrointestinal disorders	5-hydroxytryptophan (5-HTP) and Placebo	0	15	0
other	Headache	Nervous system disorders	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	0	15	0
other	Headache	Nervous system disorders	Placebo	0	15	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	0	15
Total, all-cause mortality	Placebo	0	15
Total, all-cause mortality	Ergoloid Mesylates (EM) and Placebo	0	15
Total, all-cause mortality	5-hydroxytryptophan (5-HTP) and Placebo	0	15
Total, other adverse events	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	1	15
Total, other adverse events	Placebo	3	15
Total, other adverse events	Ergoloid Mesylates (EM) and Placebo	2	15
Total, other adverse events	5-hydroxytryptophan (5-HTP) and Placebo	1	15
Total, serious adverse events	Ergoloid Mesylates (EM) and 5-hydroxytryptophan (5-HTP)	0	15
Total, serious adverse events	Placebo	0	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

Tests1

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

Test	Named as
Go/No-Go Task	Secondary outcome

Source ConductCognition

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone 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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