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Dietary Supplement

Ergoloid Mesylate for Fragile X Syndrome

Phase 2
Waitlist Available
Led By Elizabeth Berry-Kravis, MD, PhD
Research Sponsored by Elizabeth Berry-Kravis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 21 weeks
Awards & highlights

Study Summary

This trial assesses the safety, tolerability and efficacy of Ergoloid mesylates (EM), 5-hydroxytryptophan (5-HTP), and the combination of EM + 5-HTP compared to placebo in males aged 18-45 years old with Fragile X Syndrome.

Eligible Conditions
  • Fragile X Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability
Secondary outcome measures
Aberrant Behavior Checklist (ABC)
Anxiety, Depression, and Mood Scale (ADAMS)
Clinical Global Impression Improvement
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Ergoloid mesylates (EM) and placeboExperimental Treatment2 Interventions
Ergoloid mesylates (EM) 1 mg three times daily and 1 placebo capsule three times daily for 4 weeks.
Group II: Ergoloid mesylates (EM) and 5-hydroxytryptophan (5-HTP)Experimental Treatment2 Interventions
Ergoloid mesylates (EM) 1 mg three times daily and 5-hydroxytryptophan (5-HTP) 100 mg three times daily for 4 weeks
Group III: 5-hydroxytryptophan (5-HTP) and placeboExperimental Treatment2 Interventions
5-hydroxytryptophan (5-HTP) 100 mg three times daily and 1 placebo capsule three times daily for 4 weeks.
Group IV: PlaceboPlacebo Group1 Intervention
2 placebo capsules three times daily for 4 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ergoloid Mesylate
2021
Completed Phase 2
~20
5-Hydroxytryptophan / Vitamin B6
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Elizabeth Berry-KravisLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
1 Trials studying Fragile X Syndrome
110 Patients Enrolled for Fragile X Syndrome
Elizabeth Berry-Kravis, MD, PhDPrincipal InvestigatorRush University Medical Center
4 Previous Clinical Trials
235 Total Patients Enrolled
4 Trials studying Fragile X Syndrome
235 Patients Enrolled for Fragile X Syndrome

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been given access to this clinical experiment?

"Affirmative. Clinicaltrials.gov reveals that the trial, which was initially uploaded on October 7th 2021, is still recruiting participants. 15 individuals are needed from a single medical centre for this experiment to be successful."

Answered by AI

Who is eligible to participate in this medical experiment?

"Candidates who suffer from fraxa syndrome and are between 18-45 years old may qualify for this clinical trial. A total of 15 participants must be recruited to complete the study."

Answered by AI

Are there any current opportunities for patient enrollment in this trial?

"According to clinicaltrials.gov, this trial is still open for patient enrollment and was initially posted on October 7th 2021. The information has been recently updated on June 27th 2022."

Answered by AI

Are elderly people excluded from this clinical examination?

"The conditions to join this medical trial demand that candidates must be between the ages of 18 and 45. Alternatively, 372 clinical trials are available for minors while 982 studies accept adults over 65 years old."

Answered by AI

Could you provide further insight into the history of research involving Ergoloid Mesylate?

"Currently, there is one clinical trial in progress which is examining the effects of Ergoloid Mesylate. It has not yet reached phase 3 and recruitment sites are mostly located in Chicago."

Answered by AI

What safety protocols should be followed when utilizing Ergoloid Mesylate?

"Ergoloid Mesylate has been given an assessment of 2 due to the presence of safety data but lack of efficacy information from this Phase 2 trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X Syndrome
Elizabeth Berry-Kravis 2021. "Single Blind Study of Ergoloid Mesylates, 5-HTP and the Combination in Adult Males With Fragile X Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05030129.
~4 spots leftby Apr 2025
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