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Efficacy and Tolerability of Tasipimidine in Sleepless Patients

NCT06956495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2025-10-22

No results posted yet for this study

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

Interventions

DRUG

Tasipimidine

Tasipimidine solution

DRUG

Tasipimidine placebo

Tasipimidine placebo solution

Sponsors & Collaborators

  • ICON Clinical Research

    collaborator INDUSTRY

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Clinical Study Director · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-20
Primary Completion
2025-09-11
Completion
2025-09-24
FDA Drug
Yes

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06956495 on ClinicalTrials.gov