InsomniaPhase 2UnitasNCT06956495
Efficacy and Tolerability of Tasipimidine in Sleepless Patients
A Phase 2 study testing Tasipimidine in people with Insomnia, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Tasipimidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteFinland
- Study dates
- 20 Aug 2023to 24 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Systolic blood pressure < 100 or > 160 mmHg or diastolic blood pressure < 50 or > 100 mmHg
- Abnormal 12-lead ECG finding.
- Significant abnormal laboratory findings including positive drug screen and presence of alcohol in breath test.
- Pre-planned elective surgery.
- Pregnant or lactating females.
- Blood donation or loss of significant amount of blood prior to the study.
- Participation in a drug study within 60 days prior to the study.
- Restless legs syndrome, circadian rhythm disorder, REM behaviour disorder, or narcolepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Tasipimidine After 3 Repeated Bed-Time Doses in Patients With Insomnia Disorder With a 4-week Extension Part
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
- Being tested
- Tasipimidine, Tasipimidine placebo
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TasipimidineDrug
Also called ODM-105
Tasipimidine solution
Tasipimidine placeboDrug
Also called ODM-105 placebo
Tasipimidine placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Tasipimidine Dose level 1 | Experimental | Dose level 1 Receives: Drug: Tasipimidine |
| Tasipimidine Dose level 2 | Experimental | Dose level 2 Receives: Drug: Tasipimidine |
| Tasipimidine Dose level 3 | Experimental | Dose level 3 Receives: Drug: Tasipimidine |
| Placebo | Placebo comparator | Tasipimidine Placebo Receives: Drug: Tasipimidine placebo |
| Tasipimidine Dose level 4 | Experimental | Dose level 4 Receives: Drug: Tasipimidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Treatment Day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start20 Aug 2023
- Primary completion11 Sep 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
- Investigators
- Clinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956495
- Sponsor's protocol ID
- 3110012
- Other IDs
- 2022-502483-21-00, ISRCTN35042256
- Acronym
- Unitas
- Status last verified
- Oct 2025
- First submitted
- 24 Apr 2025
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Tasipimidine After 3 Repeated Bed-Time Doses in Patients With Insomnia Disorder With a 4-week Extension Part
- ClinicalTrials.gov ID
- NCT06956495
- Acronym / sponsor ID
- Unitas / 3110012
- Conditions
- Insomnia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Tasipimidine Dose level 1 | Experimental | Drug: TasipimidineDose level 1 |
| Tasipimidine Dose level 2 | Experimental | Drug: TasipimidineDose level 2 |
| Tasipimidine Dose level 3 | Experimental | Drug: TasipimidineDose level 3 |
| Placebo | Placebo comparator | Drug: Tasipimidine placeboTasipimidine Placebo |
| Tasipimidine Dose level 4 | Experimental | Drug: TasipimidineDose level 4 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TasipimidineAlso: ODM-105Tasipimidine solution | Drug | Tasipimidine Dose level 1, Tasipimidine Dose level 2, Tasipimidine Dose level 3, Tasipimidine Dose level 4 |
| Tasipimidine placeboAlso: ODM-105 placeboTasipimidine placebo solution | Drug | Placebo |
Primary outcome
Wake after sleep onset (WASO) combined from Part 1 and Part 2
Time frame: Treatment Day 1 and 2
Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2
Latency to persistent sleep (LPS) combined from Part 1 and Part 2
Time frame: Treatment Day 1 and 2
Assessed with polysomnography (PSG) for Day 1 and Day 2 data combined from Part 1 and Part 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Director study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tasipimidine in people with Insomnia, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wake after sleep onset (WASO) combined from Part 1 and Part 2 (time frame: Treatment Day 1 and 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.