At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 528 enrolled
Drug / intervention
Lu AF35700drug
Likely dose
Lu AF35700 20 mgfrom 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.
Interventional, Open-label, Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
In Brief
A Phase 3 clinical trial evaluating Lu AF35700 for Schizophrenia. Completed, enrolled 528 participants across 102 sites in 13 countries.
Detailed Summary
To evaluate the safety and tolerability of the long-term treatment with Lu AF35700.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesBulgaria, Canada, Czechia, Estonia, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
First PostedSep 2016
Primary CompletionOct 2019
TodayJul 2026
First PostedSep 8, 2016
Enrollment StartAug 1, 2016
Primary CompletionOct 10, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.8 years ago
Interventions
Lu AF35700drug
Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally. From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day) Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study