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

Summary

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

Timeline

Start

2017-03-30

Primary completion

2019-07-22

Completion

2019-07-22

Outcome

Missed primary endpoint

registry analysis (superiority test); Tesomet 0.50/50 mg vs Placebo (Adult); p = 0.1045; LS Mean Difference -5.4 (95% CI -12.3 to 1.5) NCT03149445 ↗

registry analysis (superiority test); Tesomet 0.125/25 mg -> Tesomet 0.125/25 mg vs Placebo -> Tesomet 0.125/25 mg; p = 0.0460; LS Mean Difference 5.6 (95% CI 0.1 to 11.0) NCT03149445 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metoprolol	Other / unclassified	—	—
Subject	Tesofensine	Small molecule	—	—

Indications