Efficacy and Tolerability of Tasipimidine in Sleepless Patients

NCT06956495 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: 31100122022-502483-21-00ISRCTN35042256
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• Wake after sleep onset (WASO) combined from Part 1 and Part 2

  Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2

  Treatment Day 1 and 2

• Latency to persistent sleep (LPS) combined from Part 1 and Part 2

  Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2

  Treatment Day 1 and 2

Study Arms (5)

Tasipimidine Dose level 1

EXPERIMENTAL

Dose level 1

Drug: Tasipimidine

Tasipimidine Dose level 2

EXPERIMENTAL

Dose level 2

Drug: Tasipimidine

Tasipimidine Dose level 3

EXPERIMENTAL

Dose level 3

Drug: Tasipimidine

Placebo

PLACEBO COMPARATOR

Tasipimidine Placebo

Drug: Tasipimidine placebo

Tasipimidine Dose level 4

EXPERIMENTAL

Dose level 4

Drug: Tasipimidine

Interventions

Tasipimidine DRUG

Tasipimidine solution

Also known as: ODM-105

Tasipimidine Dose level 1; Tasipimidine Dose level 2; Tasipimidine Dose level 3; Tasipimidine Dose level 4

Tasipimidine placebo DRUG

Tasipimidine placebo solution

Also known as: ODM-105 placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent (IC) for participation in the study.
• Male or female subjects with age between 18 and 65 years.
• Insomnia disorder
• Self-reported history of the following on at least 3 nights per week and for at least 3 months prior to the screening: ≥ 30 minutes to fall asleep, subjective total sleep time ≤ 6 hours.
• Insomnia Severity Index© (ISI©) score ≥ 15 in Part 1 and ≥ 11 in Part 2.
• Usual bedtime between 21:00 and 02:00.
• Regular time in bed between 6 and 9 hours.
• Meeting predefined sleep parameter criteria in sleep recording on the 2 screening nights.
• Highly effective contraception.

You may not qualify if:

• Body mass index below 18.5 or above 40.0 kg/m2.
• Daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
• Shift work within 2 weeks prior to the screening visit, or planned shift work during the study.
• Travel across ≥ 3 time zones within 2 weeks prior to the screening visit, or planned travel across ≥ 3 time zones during the study.
• Use of certain medications affecting central nervous system, e.g. sedatives or stimulans.
• Start of other new chronic medication within 14 days prior screening nights and planned change to an ongoing chronic medication during the study.
• Cognitive behavioural therapy (CBT) is allowed if the CBT started at least 1 month prior to the 1st screening night and the subject agreed to continue the CBT throughout the study.
• Diagnosed sleep-related breathing disorder, including chronic obstructive pulmonary disease and sleep apnoea.
• Acute or unstable psychiatric conditions.
• Alcohol or substance use disorder within 2 years prior to the screening visit or inability to refrain from drinking alcohol for at least 3 consecutive days.
• Significant cardiac disease.
• Significant postural hypotension.
• Heavy tobacco or other nicotine containing product use.
• Caffeine consumption ≥ 600 mg per day or regular caffeine consumption after 4 p.m.
• Heart rate \< 50 bpm or \> 100 bpm.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead
• ICON Clinical Research: collaborator

Study Sites (1)

Terveystalo Helsinki Uniklinikka

Helsinki, 00380, Finland

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: escalating dose levels administered to sequential cohorts of subjects. Part 2: participants randomised to parallel groups receiving one of the selected dose levels or placebo

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 4, 2025
• Study Start: August 20, 2023
• Primary Completion: September 11, 2025
• Study Completion: September 24, 2025
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)