Status:
COMPLETED
Efficacy and Tolerability of Tasipimidine in Sleepless Patients
Lead Sponsor:
Orion Corporation, Orion Pharma
Collaborating Sponsors:
ICON Clinical Research
Conditions:
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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-alik...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06956495
Start Date
August 20 2023
End Date
September 24 2025
Last Update
October 22 2025
Active Locations (1)
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1
Terveystalo Helsinki Uniklinikka
Helsinki, Finland, 00380