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NCT05307679 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Basmisanil Treatment in Children Aged 2-14 Years With Dup15q Syndrome
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT05307679 is a Phase 2 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 7 participants.
The verdict
NCT05307679, a Phase 2 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This study consists of two parts. Part 1 will evaluate the safety, efficacy, and pharmacodynamics of 52-weeks of basmisanil treatment in children and adolescents (aged 2-14 years) with Dup15q syndrome. Part 1 will test the hypothesis that negative allosteric modulation of a GABAA receptor subtype can address excessive receptor function and positively impact core neurodevelopmental disease feature in individuals with Dup15q syndrome. Part 2 is an optional 2-year open-label extension to evaluate long-term safety, tolerability, and to provide supportive evidence of benefit of continued treatment with basmisanil in selected efficacy outcomes.
Interventions
- DRUG Placebo
- DRUG Basmisanil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-12-16 |
| Est. Completion | 2024-03-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05307679
The ClinicalTrials.gov registry entry for NCT05307679 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05307679 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05307679 about?
NCT05307679 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Basmisanil Treatment in Children Aged 2-14 Years With Dup15q Syndrome". This study consists of two parts. Part 1 will evaluate the safety, efficacy, and pharmacodynamics of 52-weeks of basmisanil treatment in children and adolescents (aged 2-14 years) with Dup15q syndrome. Part 1 will test the hypothesis that negative allosteric modulation of a GABAA receptor subtype ca...
What is the current status of trial NCT05307679?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2022-12-16. Estimated completion is 2024-03-04.
What interventions are being tested in trial NCT05307679?
The interventions under investigation include: Placebo (DRUG), Basmisanil (DRUG).
Who is sponsoring clinical trial NCT05307679?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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