NCT06956495

Efficacy and Tolerability of Tasipimidine in Sleepless Patients

Efficacy and Tolerability of Tasipimidine After 3 Repeated Bed-Time Doses in Patients With Insomnia Disorder With a 4-week Extension Part

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Tasipimidine	Tasipimidine solution
DRUG	Tasipimidine placebo	Tasipimidine placebo solution

Timeline

• Start date: 2023-08-20
• Primary completion: 2025-09-11
• Completion: 2025-09-24
• First posted: 2025-05-04
• Last updated: 2025-10-22

Locations

1 site across 1 country: Finland

Regulatory

• FDA-regulated drug study