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Lemborexant for Nocturia

(LENS Trial)

AS
WG
Overseen ByWilliam Gibson, MD
Age: 65+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Nocturia is defined by doctors as getting up one or more times a night to use the bathroom, where you were asleep before going to use the washroom and then going back to sleep afterward. People who experience this condition describe it was one of their biggest problems. This condition is very common as people get older and can seriously affect older peoples quality of life including disruptions to sleep, daily functioning, risk of falls and even early death.

Are You a Good Fit for This Trial?

This trial is for adults who wake up at least once a night to urinate (nocturia). It mainly targets older individuals whose sleep and daily life are affected by this problem. People with certain medical conditions or on medications that could interfere may not be able to join.

Inclusion Criteria

I wake up at night to urinate, as measured by a standard questionnaire.
I have been on the same OAB treatment for at least 12 weeks.
I still wake up at night to urinate after 4 weeks of treatment, and it bothers me a lot.
See 1 more

Exclusion Criteria

Participant has 24h polyuria (>3L) measured by a 7-day bladder diary
Participant has post-void residual (>250mL) measured by ultrasound following void from a comfortably full bladder
Other conditions which would preclude inclusion
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • Lemborexant

Trial Overview

The study compares lemborexant tablets, a medication aimed at improving sleep, against placebo (inactive pills) to see if it helps reduce nighttime bathroom trips in people with nocturia.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Sequence B: Placebo then LemborexantExperimental Treatment1 Intervention
Group II: Sequence A: Lemborexant then PlaceboExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Eisai Inc.

Industry Sponsor

Trials
524
Recruited
161,000+
Founded
Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.
Headquarters
Woodcliff Lake, NJ, USA
Known For
Neurology and Oncology
Top Products
Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)
Lynn Kramer profile image

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno profile image

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

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