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

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 7, 2021

Primary Completion Date

January 19, 2023

Study Completion Date

January 19, 2023

Conditions
Fragile X Syndrome
Interventions
DRUG

5-Hydroxytryptophan

5-HTP will be over-encapsulated in identical size 00 capsules. During the 5-HTP Treatment Period (Period 3) and 5-HTP/EM Treatment Period (Period 2), subjects will take 1 capsule of 5-HTP 3 times per day.

DRUG

Ergoloid Mesylates

Ergoloid mesylates 1 mg will be mixed with methyl cellulose and placed in a size 00 capsule. During the EM Treatment Period (Period 1) and 5-HTP/EM Treatment Period (Period 2), subjects will take 1 capsule of EM 3 times per day.

DRUG

Matching placebo for Ergoloid mesylates

Matching placebo for Ergoloid mesylates will be ascorbic acid powder in identical size 00 capsules. During the 5-HTP Treatment Period (Period 3) and Placebo Treatment Period (Period 4), subjects will take 1 capsule of matching placebo for EM 3 times per day.

DRUG

Matching placebo for 5-Hydroxytryptophan

Matching placebo for 5-Hydroxytryptophan will be ascorbic acid powder in identical size 00 capsules. During the EM Treatment Period (Period 2) and Placebo Treatment Period (Period 4), subjects will take 1 capsule of matching placebo for 5-HTP 3 times per day.

Trial Locations (1)

60612

Rush University Medical Center, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

FRAXA Research Foundation

OTHER

collaborator

Purposeful IKE

INDUSTRY

lead

Elizabeth Berry-Kravis

OTHER