At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 18 enrolled
Drug / intervention
Tesofensine/Metoprolol +1 moredrug
Likely dose
Not stated in 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.
A Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose, Multi-Center Safety and Efficacy Study of Co-Administration of Tesofensine/Metoprolol for 12 Weeks in Adult and Adolescent Patients With Prader-Willi Syndrome (PWS), Followed by Two Open Label 12 Weeks Extension Periods for Adolescent Patients
In Brief
A Phase 2 clinical trial evaluating Tesofensine/Metoprolol and Placebos for Confirmed Genetic Diagnosis of Prader-Willi Syndrome. Completed, enrolled 18 participants across 2 sites in 2 countries.
Detailed Summary
Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study followed by two open label extension periods.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Hungary
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedMay 2017
Primary CompletionJul 2019
TodayJul 2026
First PostedMay 11, 2017
Enrollment StartMar 30, 2017
Primary CompletionJul 22, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.1 years ago
Interventions
Tesofensine/Metoprololdrug
Study medication will be administered for 91 days.
Placebosdrug
Study medication will be administered for 91 days.