At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 28 enrolled
Drug / intervention
NNZ-2591drug
Likely dose
NNZ-2591 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Pitt Hopkins Syndrome (PTHS-001)
In Brief
A Phase 2 clinical trial evaluating NNZ-2591 for Pitt Hopkins Syndrome. Completed, enrolled 28 participants across 5 sites.
Detailed Summary
A study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Pitt Hopkins Syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPitt Hopkins Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartOct 2022
Primary CompletionFeb 2024
Study CompletionMay 2024
TodayJul 2026
First PostedAug 27, 2021
Enrollment StartOct 14, 2022
Primary CompletionFeb 27, 2024
Study CompletionMay 3, 2024
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 4.8 years ago
Interventions
NNZ-2591drug
NNZ-2591 oral solution (50mg/mL) to be administered twice daily dose for 13 weeks.