Conditions: Insomnia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: yes

Brief summary:
Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects.

Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None arm 14: None

Interventions: intervention 1: E2006 1.0 mg intervention 2: E2006 2.5 mg intervention 3: E2006 5.0 mg intervention 4: E2006 10.0 mg intervention 5: E2006 25.0 mg intervention 6: E2006 50.0 mg intervention 7: E2006 100 mg intervention 8: E2006 200 mg intervention 9: Zolpidem 10 mg intervention 10: E2006 Matched Placebo or Zolpidem Matched Placebo intervention 11: E2006 Matched Placebo
Intervention descriptions: intervention 1: E2006 1.0 mg capsule. intervention 2: E2006 2.5 mg capsule. intervention 3: E2006 5.0 mg (2 capsules of 2.5 mg each). intervention 4: E2006 10.0 mg capsule. intervention 5: E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each). intervention 6: E2006 50.0 mg capsule. intervention 7: E2006 100 mg (2 capsules of 50 mg each). intervention 8: E2006 200 mg (4 capsules of 50 mg each). intervention 9: Zolpidem 10 mg immediate release tablet. intervention 10: E2006-matched placebo capsules or zolpidem-matched placebo tablets. intervention 11: E2006-matched placebo capsule.

Protocol document: