Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
Condition: Chronic Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: ACT-078573 oral capsules at 25 and 100 mg and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo; ACT-078573 and matching placebo
Intervention description: 5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo; ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: insomnia; elderly; sleeplessness

Summary:

      A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and
      tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with
      primary insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Elderly subjects (> 64 years) with a diagnosis of primary insomnia.

        Exclusion Criteria:

          -  History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental
             Disorders IV (DSM-IV) axis I disorder other than primary insomnia.

          -  Sleep apnea, or restless legs syndrome.

          -  Daytime napping of more than 1 hour per day.

          -  Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2
             years prior to the screening visit.

          -  Unwillingness to refrain from drugs, over-the-counter or herbal medication having an
             effect on sleep or behavior.