SPG601 for Fragile X Syndrome
Trial Summary
What is the purpose of this trial?
This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome.
Do I have to stop taking my current medications?
The trial requires that you have stable dosing of psychotropic drugs for at least 4 weeks before participating. Other medications are not specifically mentioned, so the protocol does not specify if you need to stop taking them.
What data supports the idea that SPG601 for Fragile X Syndrome is an effective drug?
The available research does not provide specific data on SPG601 for Fragile X Syndrome. However, it mentions other treatments like eFT508, which improved various symptoms in mice, and STX209, which corrected synaptic issues in a mouse model. Mavoglurant did not show significant improvement in human trials. Without direct data on SPG601, we cannot confirm its effectiveness compared to these treatments.12345
What safety data is available for SPG601 treatment?
The provided research does not contain specific safety data for SPG601 or its other names. The studies focus on different compounds, such as sodium 2,2 dimethylbutyrate (SDMB) and HQK-1001, which are not identified as SPG601. Therefore, no relevant safety data for SPG601 is available in the provided research.678910
Is the drug SPG601 a promising treatment for Fragile X Syndrome?
Research Team
Craig Erickson, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of SPG601 or placebo at the first visit and cross over to receive the other product at the second visit
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- SPG601
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spinogenix
Lead Sponsor
Avance Clinical Pty Ltd.
Industry Sponsor