Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2025-12-24 @ 1:47 PM
NCT ID:
NCT06956495
Brief 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.
Study:
NCT06956495
Study Brief:
Protocol Section:
NCT06956495