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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). 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.
Primary Outcome
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, and ganaxolone may provide more direct benefits or increased tolerability compared to atypical antipsychotics.
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 |
What is known before NCT07635862 opens enrollment
NCT07635862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07635862 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07635862's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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