A single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 4-way cross-over study to assess next-day driving performance following single and multiple evening administrations of ACT-541468 in middle-aged and elderly subjects.

A single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 4-way cross-over study to assess next-day driving performance following single and multiple evening administrations of ACT-541468 in middle-aged and elderly subjects. - Driving performance of ACT-541468

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48154

Enrollment

Registered

2019-02-27

Start date

2019-03-16

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Subject will be randomized into any of the four treatment sequences (A, B, C, D) in a cross-over fashion. A: ACT-541468 50 mg, zopiclone 7.5 mg, Placebo, ACT-541468 100 mg B: ACT-541468 100 mg, Plac

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Be male or female (of nonchildbearing potential) aged 50 to 80 years, inclusive, at the Screening Visit. 2. Have a body mass index *18.5 and *30.0 kg/m2 at the Screening Visit. 3. Be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination and vital sign measurements performed at the screening visit and before the first dose of study drug.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Known hypersensitivity to ACT-541468, zopiclone, or treatments of the same class, or any of their excipients. 3. Unstable medical condition, significant medical disorder, or acute illness within 2 months prior to Screening. 4. Current heavy tobacco user (* 15 cigarettes per day) or smoker with an urge to wake up during the night to smoke. 5. No history of narcolepsy, cataplexy or fainting. 6. Mini Mental State Examination (MMSE) score

Design outcomes

Primary

Measure	Time frame
Driving performance as measured by the SDLP (difference from placebo, cm) on Day 2 and 5 at 9 h post dose following administration of ACT-541468.	—

Secondary

Measure	Time frame
Effects of ACT-541468 on Days 2 and 5 on other driving performance parameters 9 h post dose: - Mean lateral position (MLP). - Mean speed (MS). - SD of the mean speed (SDMS). - Number of lapses (lapses are short periods of inattention and reduced alertness which may be a risk factor for car crashes. A lapse is defined as change from the steady lateral position of * 100 cm for * 4 s.) - Drive safety score (DSS), a 24-item composite safety score. - Subjective driving performance and effort scale. Safety endpoints: - Treatment-emergent AEs from study treatment administration up to EOT in each treatment period. - Treatment-emergent SAEs from study treatment administration up to EOT in each treatment period.	—

Measure

Time frame

Effects of ACT-541468 on Days 2 and 5 on other driving performance parameters 9 h post dose: - Mean lateral position (MLP). - Mean speed (MS). - SD of the mean speed (SDMS). - Number of lapses (lapses are short periods of inattention and reduced alertness which may be a risk factor for car crashes. A lapse is defined as change from the steady lateral position of * 100 cm for * 4 s.) - Drive safety score (DSS), a 24-item composite safety score. - Subjective driving performance and effort scale. Safety endpoints: - Treatment-emergent AEs from study treatment administration up to EOT in each treatment period. - Treatment-emergent SAEs from study treatment administration up to EOT in each treatment period.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)