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SPG601 for Fragile X Syndrome

Phase 2
Recruiting
Led By Craig Erickson, MD
Research Sponsored by Spinogenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult males aged 18 to 45 years
Diagnosis of Fragile X as confirmed with genetic testing
Must not have
Uncontrolled seizures or history of epilepsy with a seizure in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 days

Summary

This trial will test a new medication called SPG601 in adult men with Fragile X syndrome to see if it is safe, effective, and well-tolerated, and to understand how the medication

Who is the study for?
Adult men aged 18-45 with Fragile X Syndrome can join this trial if they're in good health, have stable use of psychotropic drugs for at least a month, and are using contraception. They need a caregiver and confirmed diagnosis via genetic testing. Those with uncontrolled seizures, recent substance abuse, or conditions affecting study completion cannot participate.
What is being tested?
The trial is testing SPG601's safety and effectiveness compared to a placebo in treating adult men with Fragile X Syndrome. It will also look into how the body processes the drug and its impact on the body's functions.
What are the potential side effects?
Specific side effects of SPG601 aren't listed here but generally may include reactions related to drug tolerance such as digestive issues, headaches, potential allergic reactions or other unforeseen responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 18 and 45.
Select...
My condition is genetically confirmed Fragile X.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a seizure or uncontrolled epilepsy in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in auditory response to chirp stimulus
Clinical Global Impressions Improvement scale as determined by the caregiver
Clinical Global Impressions Improvement scale as determined by the treating clinician
+1 more
Secondary study objectives
Change in attention and inhibition symptoms
Change in auditory response to steady state auditory stimuli
Change in cognitive outcomes measured by NIH Cognitive Toolbox
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Experimental: Active SPG601 to be administered to participants with Fragile X SyndromeActive Control1 Intervention
Participants with Fragile X Syndrome will be randomized to receive SPG601 or placebo (8 capsules of 100 mg) one time on days 1 and 8 of the study.
Group II: Placebo Comparator: Placebo comparator to be administered to participants with Fragile X SyndromePlacebo Group1 Intervention
Participants with Fragile X Syndrome will be randomized to receive SPG601 or placebo (8 capsules of 100 mg) one time on days 1 and 8 of the study.

Find a Location

Who is running the clinical trial?

SpinogenixLead Sponsor
3 Previous Clinical Trials
168 Total Patients Enrolled
Avance Clinical Pty Ltd.Industry Sponsor
18 Previous Clinical Trials
3,372 Total Patients Enrolled
Craig Erickson, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
5 Previous Clinical Trials
153 Total Patients Enrolled
2 Trials studying Fragile X Syndrome
118 Patients Enrolled for Fragile X Syndrome
~2 spots leftby Dec 2024
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