Testing Tasipimidine for Insomnia Treatment

Efficacy and Tolerability of Tasipimidine After 3 Repeated Bed-Time Doses in Patients With Insomnia Disorder With a 4-week Extension Part

This study is testing if tasipimidine can help people with insomnia sleep better compared to a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Orion Corporation, Orion Pharma (Industry-sponsored)
• Locations: 1 site (Helsinki)
• Trial ID: NCT06956495 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the efficacy and safety of tasipimidine in treating insomnia by comparing it to a placebo. Participants will undergo a screening period followed by a treatment phase lasting three consecutive days and nights, with a post-treatment observation period. The study consists of two parts, with the second part including an additional four-week home treatment phase where participants will take tasipimidine or placebo nightly. Sleep parameters will be recorded using equipment and sleep diaries during both the clinic and home phases.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of insomnia disorder and specific sleep difficulties.

Not a fit: Patients with a body mass index outside the range of 18.5 to 40.0 kg/m2 or those who frequently nap during the day may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from insomnia.

How similar studies have performed: Previous studies have shown varying degrees of success with similar pharmacological approaches to treating insomnia, but this specific intervention is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Helsinki

• Terveystalo Helsinki Uniklinikka — Helsinki, Finland (Recruiting)

Study contacts

• Study coordinator: Clinical Study Director

Conditions Insomnia