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NCT05030129 · ClinicalTrials.gov registry record · Phase 2
ERG/5-HTP in Fragile X Syndrome (FXS)
A Phase 2 study of Fragile X Syndrome, sponsored by Elizabeth Berry-Kravis.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05030129: Completed Phase 2 study of Fragile X Syndrome, sponsored by Elizabeth Berry-Kravis.
NCT05030129 is a Phase 2 study of Fragile X Syndrome that has completed, run by Elizabeth Berry-Kravis. The registered enrollment target is 15 participants, below the 101-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05030129, a Phase 2 study of Fragile X Syndrome, has completed, sponsored by Elizabeth Berry-Kravis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 5-Hydroxytryptophan
- DRUG Ergoloid Mesylates
- DRUG Matching placebo for Ergoloid mesylates
- DRUG Matching placebo for 5-Hydroxytryptophan
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-10-07 |
| Est. Completion | 2023-01-19 |
| Phase | Phase 2 |
What the finished NCT05030129 record still lists
NCT05030129 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 101-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 4 interventions - of which 5-Hydroxytryptophan is the first listed.
NCT05030129 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT05030129 about?
NCT05030129 is a clinical study titled "ERG/5-HTP in Fragile X Syndrome (FXS)". 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.
What is the current status of trial NCT05030129?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2021-10-07. Estimated completion is 2023-01-19.
What conditions does trial NCT05030129 study?
This clinical trial studies the following conditions: Fragile X Syndrome.
What interventions are being tested in trial NCT05030129?
The interventions under investigation include: 5-Hydroxytryptophan (DRUG), Ergoloid Mesylates (DRUG), Matching placebo for Ergoloid mesylates (DRUG), Matching placebo for 5-Hydroxytryptophan (DRUG).
Who is sponsoring clinical trial NCT05030129?
This trial is sponsored by Elizabeth Berry-Kravis, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05030129 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05030129's enrollment target sits among peer trials
15 15th of 16 higher than 1 of 16 other Fragile X Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fragile X Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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