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NCT07635862 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism
A Phase 2 study, sponsored by Stanford University.
- Not yet
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT07635862: Clinical Trial Phase 2 study, sponsored by Stanford University.
NCT07635862 is a Phase 2 study that has not yet begun recruiting, run by Stanford University. The registered enrollment target is 66 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07635862, a Phase 2 study, has not yet begun recruiting, sponsored by Stanford University.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
The goal of this study is to conduct a randomized, placebo-controlled trial (RCT) of ganaxolone, a neuroactive steroid (NAS), in autistic children and adolescents aged 5 to 17 years old. Ganaxolone is approved and effective for treating seizures in children as young as 2 years old who have CDKL5 deficiency disorder (CDD), a neurogenetic condition associated with developmental delays, seizure disorder, hypotonia, visual impairments, and autistic features. The primary outcome of interest for this trial is irritability on the Aberrant Behavior Checklist (ABC) because it is a common symptom of emotion dysregulation in ASD that impacts quality of life, including mental health, independence, educational opportunities, and integration into the community. The secondary domains of interest for this trial are restricted and repetitive behaviors (RRB), specifically insistence on sameness (IS), a subdomain of RRB characterized by inflexibility and a strong preference for predictable routines and familiar environments. Secondary outcome measures include the IS subscale from the Dimensional Assessment of Repetitive Behaviors (DARB) and subscales of the Clinical Global Impressions Scale for irritability (CGI-IR) and IS (CGI-IS). For participants living within 150 miles of Stanford University, we require participants to attend site visits and attempt EEG and MRI procedures before and after the trial, though we are recruiting nationally and the study can be completed without site vists.
Interventions
- DRUG Placebo
- DRUG Ganaxolone (Ztalmy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2030-01-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07635862
The ClinicalTrials.gov registry entry for NCT07635862 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07635862 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07635862 about?
NCT07635862 is a clinical study titled "Clinical Trial Evaluating the Effects of Ganaxolone in Children With Autism". The goal of this study is to conduct a randomized, placebo-controlled trial (RCT) of ganaxolone, a neuroactive steroid (NAS), in autistic children and adolescents aged 5 to 17 years old. Ganaxolone is approved and effective for treating seizures in children as young as 2 years old who have CDKL5 def...
What is the current status of trial NCT07635862?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2027-01-01. Estimated completion is 2030-01-01.
What interventions are being tested in trial NCT07635862?
The interventions under investigation include: Placebo (DRUG), Ganaxolone (Ztalmy) (DRUG).
Who is sponsoring clinical trial NCT07635862?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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