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

NCT05030129 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-19

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and efficacy of Ergoloid mesylates (EM) and 5-hydroxytryptophan (5-HTP) and the combination (EM + 5-HTP) compared to placebo in males aged 18-45 years old with Fragile X Syndrome.

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.

Sponsors & Collaborators

  • FRAXA Research Foundation

    collaborator OTHER

  • Purposeful IKE

    collaborator INDUSTRY

  • Elizabeth Berry-Kravis

    lead OTHER

Principal Investigators

  • Elizabeth Berry-Kravis, MD, PhD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2023-01-19
Completion
2023-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05030129 on ClinicalTrials.gov