Efficacy and Tolerability of Tasipimidine in Sleepless Patients

Summary

The goal of this trial is to learn if tasipimidine will help in the treatment of insomnia and how safe it is to use in sleepless people. Researchers will compare tasipimidine to a placebo (a look-alike substance that contains no drug) to see if tasipimidine works to treat insomnia. The trial consists of 2 consecutive parts and participants will be included either in Part 1 or Part 2. Part 2 will start only after Part 1 completion. Both parts include a screening period (up to 6 weeks), a treatment period (3 consecutive days and nights) and a post-treatment period (up to 10 days). Part 2 includes an additional 4 week extension part, where the participants take tasipimidine or placebo every evening at home and return to the sleep clinic for 2 last treatment nights. Participants will use equipment to record sleep parameters both at sleep clinic and home (Part 2) and a sleep diary is used.

Timeline

Start

2023-08-20

Primary completion

2025-09-11

Completion

2025-09-24

Outcome

Missed primary endpoint

release “ODM-105 (tasipimidine) did not meet the primary goal in the clinical Phase 2 UNITAS study for the treatment of patients with insomnia.” orionpharma.com ↗

Drugs

Indications