A Phase II Study of Basmisanil in Children and Adolescents With Dup15q Syndrome
Public ClinicalTrials.gov record NCT07846215. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of Basmisanil in Participants Aged 2 to 14 Years Old With Dup15q Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary goal of this Phase 2 clinical trial is to determine the effects of a selective negative allosteric modulator (NAM) of GABAA α5 receptor, Basmisanil (NTX-1511), on brain wave (EEG) characteristics in children and adolescents with Dup15q syndrome. The main questions this trial aims to answer are: * How does NTX-1511 affect brain waves (as measured by EEG) in subjects with Dup15q syndrome? * Does NTX-1511 impact other developmental features of subjects with Dup15q syndrome? Researchers will compare the effects of NTX-1511 with matching placebo (look-alike granules that contain no drug). Participants will: * Take NTX-1511 or matching placebo 3 times every day for 12 weeks * Visit the clinic 7 times over the course of 23 weeks
Study identification
- NCT ID
- NCT07846215
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 14 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 1, 2026 (Estimated)
- Primary completion
- May 1, 2029 (Estimated)
- Completion
- May 1, 2029 (Estimated)
- Last update posted
- Sep 29, 2026
2026 – 2029
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NTX-1511 Clinical Study Site | Chicago | Illinois | 60612 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07846215, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 29, 2026 · Synced Oct 8, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07846215 live on ClinicalTrials.gov.