NCT03149445

Co-administration of Tesofensine/Metoprolol in Subjects With Prader-Willi Syndrome (PWS)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Saniona · Industry
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study followed by two open label extension periods.

Detailed description

Two-centre, double-blind, placebo-controlled, randomized, and multiple-dose clinical study. Study medication will be administered for 91 days. The study will be conducted in two steps: * Step 1 - 9 adult subjects with PWS was treated. * Sponsor review - following the completion of the treatment of the adult subjects, unblinded efficacy, safety, Pharmacokinetic (PK) data as well as all data from the study in subjects with type 2 diabetes (TM001) will be reviewed by sponsor and an interim analysis will be done. Following competent authority positive opinion regarding the interim analysis and unblinded data the study will proceed to: * Step 2 - 9 adolescent subjects with PWS was treated. * OLE (Open Label Extension) I - Participation in a 12-week OLE I was offered to subjects who completed Step 2. 8 subjects entered OLE I. * OLE (Open Label Extension) II - Participation in a 12-week OLE II was offered to subjects who completed OLE I. 6 subjects continued to OLE II.

Conditions

• Confirmed Genetic Diagnosis of Prader-Willi Syndrome

Interventions

Type	Name	Description
DRUG	Tesofensine/Metoprolol	Study medication will be administered for 91 days.
DRUG	Placebos	Study medication will be administered for 91 days.

Timeline

• Start date: 2017-03-30
• Primary completion: 2019-07-22
• Completion: 2019-07-22
• First posted: 2017-05-11
• Last updated: 2024-02-26
• Results posted: 2024-02-26

Locations

2 sites across 2 countries: Czechia, Hungary