Health TrialsbyHealthPanel

How Well and Safely Does Lemborexant Work for People Who Wake up at Night to Urinate (LENS)

ConditionNocturia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Alberta

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥65 years

Has nocturia as determined by ICS criteria (ICIQ-N)

Has Nocturia, after 4 weeks of conservative treatment (fluid advice, leg elevation, sodium restriction, medication review, mild compression stockings where relevant), indicates a score of ≥4 on question 4b of the validated ICIQ Nocturia module [https://iciq.net/iciq-n] - (indication of bother rating of 4-10)

Participants with prior treatment for concomitant OAB should have been on stable doses of therapy for 12 weeks prior to inclusion.

Disqualifiers

Participant has a 24h polyuria (>3L), measured by a 7-day bladder diary

Participant has a post-void residual (>250mL), measured by ultrasound following void from a comfortably full bladder

Participant has an acute symptomatic UTI (can be treated and rescreened for inclusion)

The participant has known untreated sleep apnoea, or highly likely OSA according to the validated STOP-BANG questionnaire (score 5-8)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Lemborexant tablets

    Drug

    5mg (one tablet) orally at bedtime for weeks 1-3, with optional uptitration to 10mg (two tablets) for weeks 4-6.

  • Placebo

    Drug

    Matching placebo tablet, one at bedtime weeks 1-3, optionally two for weeks 4-6 to preserve masking

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Sequence A: Lemborexant then PlaceboExperimental treatment 1 intervention
Group B: Sequence B: Placebo then LemborexantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in mean nocturia episodes per 24 hours

Change in mean nocturia episodes per 24 hours, measured by a 7-day/night bladder diary between baseline and the end of each treatment period. Participants will record the time and volume of each void (day and night) for 7 consecutive days at baseline (prior to randomization) and at week 6 (the final treatment weeks: days 35-42) of each treatment period.

Time frame
42 Days

Secondary outcomes

1

Change in Epiworth Sleepiness Scale (ESS)

Change in Epiworth Sleepiness Scale between baseline and EoS. The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that assesses an individual's general level of daytime sleepiness by asking respondents to rate their likelihood of dozing in eight everyday situations. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness

Time frame
42 days
2

Change in nocturia associated quality of life

Change in nocturia associated quality of life (ICIQ-NQoL) between baseline and EoS. The International Consolation on Incontinence Nocturia Quality of Life (ICIQ NQoL) is a validated, disease-specific, patient-reported outcome instrument developed to measure the impact of nocturia on health-related quality of life. The total score equals the sum of all item responses, ranging from 0 to 58, with higher values indicating a greater impact on patient quality of life.

Time frame
42 days
3

Change in Insomnia Severity Index (ISI)

Change in Insomnia Severity Index (ISI) between baseline and EoS. The Incontinence Severity Index, developed by Sandvik and colleagues, is a validated instrument that quantifies the severity of urinary incontinence based on the frequency and amount of leakage. Scores are derived by multiplying responses on two items, yielding a severity category ranging from slight to severe.

Time frame
42 days
4

Change in mean reported first uninterrupted sleep period (FUSP)

Change in mean reported first uninterrupted sleep period (FUSP) (minutes), measured over seven days, between baseline and EoS

Time frame
42 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Eisai Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: