Eisai Co., Ltd.: Sleep Initiation and Maintenance Disorders trials

The registry lists 17 Sleep Initiation and Maintenance Disorders studies with Eisai Co., Ltd. as lead sponsor. 0 are open to participants now and 11 have results posted.

Phase 1 4Phase 2 3Phase 3 6Phase 4 1No phase 4(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia DisorderCompletedNCT05594589Phase 2Results posted
• A Study of Lemborexant in Chinese Participants With Insomnia DisorderCompletedNCT04549168Phase 3Results posted
• A Study to Evaluate Next-Dose Transition From Zolpidem to Lemborexant (LEM) for the Treatment of InsomniaCompletedNCT04009577Phase 3Results posted
• Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)CompletedNCT02952820Phase 3Results posted
• Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)CompletedNCT02783729Phase 3Results posted
• Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia DisorderCompletedNCT02350309Phase 1Results posted
• A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic InsomniaCompletedNCT01995838Phase 2Results posted
• A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006CompletedNCT01463098Phase 1Results posted
• A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)CompletedNCT01055834Phase 1Results posted
• A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)CompletedNCT00770692Phase 3Results posted
• A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)CompletedNCT00770510Phase 2/3Results posted
• A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control PopulationActive, not recruitingNCT06744673
• A Study to Evaluate the Safety of DAYVIGO (Lemborexant) Tablets in Participants With Insomnia.CompletedNCT04573556
• A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative UsersCompletedNCT03158025Phase 1
• Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia PatientsCompletedNCT02455271
• Investigation of the Safety and Efficacy of Eszopiclone in Insomnia PatientsCompletedNCT02452684
• To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset SeizuresWithdrawnNCT02220972Phase 4