NIRVANA: A Study to Learn About How Elinzanetant Works and How Safe it is in Women Having Sleep Disturbances Associated With Menopause

Sponsor

Bayer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06112756

Collaborator

(none)

Enrollment

Locations

Arms

14.1

Anticipated Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are looking for a better way to treat women who have sleep disturbances associated with menopause.

Menopause is part of a natural aging process and happens when women's menstrual cycles, also called periods, stop. Sleep disturbances, for example, frequent waking up at night, are a common and bothersome symptom associated with menopause that affects women's quality of life.

The study treatment Elinzanetant (also called BAY 3427080) is under development to treat symptoms like hot flashes which are caused by hormonal changes associated with menopause. It may block the activity of a protein that has been found to contribute to sleep disturbances.

The main purpose of this study is to learn how does elinzanetant affect sleep disturbances associated with menopause as measured on a sleep test called polysomnography (PSG) as compared with placebo.

For this, the researchers will analyze

change in the total number of minutes a participant wakes up at night after going to sleep after 4 weeks of treatment compared to before treatment
change in the total number of minutes a participant wakes up at night after going to sleep after 12 weeks of treatment compared to before treatment
change in the participant's total time asleep while in bed after 4 and 12 weeks of treatment compared to before treatment.

The study participants will be randomly (by chance) assigned to one of two treatment groups. Dependent on the group, they will take elinzanetant or placebo for 12 weeks.

Each participant will be in the study for approximately 22 weeks (plus potential washout period), including a screening phase of up to 6 weeks, 12 weeks of treatment, and a follow up phase of 4 weeks after the end of treatment. 5 visits to the study site are planned.

During the study, the doctors and their study team will:

take blood and urine samples
do physical examinations
check vital signs
do sleep tests
use an electronic hand-held device to record sleep quality and hot flashes at home

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbances Associated With Menopause	Drug: Elinzanetant Other: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Parallel-group Treatment, Phase 2, Double-blind Pilot Study to Investigate the Efficacy and Safety of Elinzanetant Compared With Placebo for Treatment of Sleep Disturbances Associated With Menopause.

Anticipated Study Start Date :

Nov 6, 2023

Anticipated Primary Completion Date :

Aug 26, 2024

Anticipated Study Completion Date :

Jan 7, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elinzanetant arm Participants will take Elinzanetant	Drug: Elinzanetant Oral
Placebo Comparator: Placebo arm Participants will take elinzanetant matching placebo	Other: Placebo Oral

Arm

Intervention/Treatment

Experimental: Elinzanetant arm

Participants will take Elinzanetant

Drug: Elinzanetant

Oral

Placebo Comparator: Placebo arm

Participants will take elinzanetant matching placebo

Other: Placebo

Oral

Outcome Measures

Primary Outcome Measures

Change from baseline in WASO as measured by PSG [At Week 4]
WASO: Wakefulness after sleep onset - total number of minutes that a participant is awake after having initially fallen asleep. PSG assessments will be performed on 2 consecutive nights.

Secondary Outcome Measures

Change from baseline in WASO as measured by PSG [At Week 12]
WASO: Wakefulness after sleep onset - total number of minutes that a participant is awake after having initially fallen asleep. PSG assessments will be performed on 2 consecutive nights.
Change from baseline in SE as measured by PSG [At Week 4]
SE: Sleep Efficiency - ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.
Change from baseline in SE as measured by PSG [At Week 12]
SE: Sleep Efficiency - ratio between the total time a participant is asleep (TST) to the total time spent in bed. Presented as a percentage.
Change from baseline in PROMIS SD SF 8b total score [At Week 4]
PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b. The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Change from baseline in PROMIS SD SF 8b total score [At Week 12]
PROMIS SD SF 8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b. The PROMIS SD SF 8b includes 8 items assessing sleep disturbance over the past 7 days. Items assess sleep quality, sleep depth and restoration associated with sleep, perceived difficulties with getting to sleep or staying asleep and perceptions of the adequacy of and satisfaction with sleep. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.
Change from baseline in ISI total score [At Week 4]
ISI: Insomnia Severity Index. The ISI is a 7 item instrument that quantifies the participant perception of insomnia severity, along with the impact of insomnia on daytime functioning in adults in the last 2 weeks. The items refer to: severity of sleep onset, sleep maintenance and early morning wakening problems, satisfaction with sleep pattern, noticeability of sleep problems by others, distress caused by the sleep difficulties and interference of sleep difficulties with daytime functioning. It is scored on a 5 point Likert scale from 0 to 4 depending on the item (0="none", 4="very severe" (Items 1-3); 0="very satisfied", 4="very dissatisfied (Item 4)"; 0="not at all noticeable", 4="very much noticeable" (Item 5); 0="not at all worried", and 4="very much worried" (Item 6); 0="not at all interfering", 4="very much interfering" (Item 7)). The scores for each item are summed to produce the total score (maximum 28), higher scores indicates greater severity.
Change from baseline in ISI total score [At Week 12]
ISI: Insomnia Severity Index. The ISI is a 7 item instrument that quantifies the participant perception of insomnia severity, along with the impact of insomnia on daytime functioning in adults in the last 2 weeks. The items refer to: severity of sleep onset, sleep maintenance and early morning wakening problems, satisfaction with sleep pattern, noticeability of sleep problems by others, distress caused by the sleep difficulties and interference of sleep difficulties with daytime functioning. It is scored on a 5 point Likert scale from 0 to 4 depending on the item (0="none", 4="very severe" (Items 1-3); 0="very satisfied", 4="very dissatisfied (Item 4)"; 0="not at all noticeable", 4="very much noticeable" (Item 5); 0="not at all worried", and 4="very much worried" (Item 6); 0="not at all interfering", 4="very much interfering" (Item 7)). The scores for each item are summed to produce the total score (maximum 28), higher scores indicates greater severity.
Number of participants with Treatment-emergent Adverse Events (TEAEs) [Up to 16 weeks]
Number of participants with Abnormal laboratory parameters [Up to 13 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Females aged 40 to 65 years, inclusive, at signing of informed consent.
Being in the post-menopausal period, defined as: serum FSH levels >40 mIU/mL and a serum estradiol concentration of <30 pg/mL at screening, AND Hysterectomy performed at least 6 weeks prior to screening.
The participant's self-reported sleep history includes ongoing sleep disturbances associated with menopause characterized by waking up at night and/or poor quality of sleep.
WASO of 30 minutes or more (mean of 2 screening PSGs with neither of the 2 nights <20 min).

Exclusion Criteria:

Medical history, or baseline PSG assessment, includes a diagnosis of a sleep disorder other than sleep disturbances associated with the menopause (e.g., sleep apnea, restless leg syndrome, circadian rhythm sleep disorder).
Current or history (except complete remission for 5 years or more) of any malignancy (except basal and squamous cell skin tumors).
Renal impairment greater than moderate (i.e. estimated glomerular filtration rate <30 mL/min/1.73 m^2) at screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Preferred Research Partners	Little Rock	Arkansas	United States	72211
2	Santa Monica Clinical Trials Los Angeles	Los Angeles	California	United States	90025
3	Pacific Research Network	San Diego	California	United States	92103
4	Pacific Clinical Research Management Group LLC	Upland	California	United States	91786
5	Meris Clinical Research	Brandon	Florida	United States	33511
6	St. Francis Medical Institute	Clearwater	Florida	United States	33765
7	PharmaDev Clinical Research Institute, LLC	Miami	Florida	United States	33176
8	Segal Trials-Women's Health & General Medicine Research Site	North Miami	Florida	United States	33161
9	Renstar Medical Research	Ocala	Florida	United States	34471
10	Palm Beach Research center	West Palm Beach	Florida	United States	33409
11	NEUROTRIALS RESEARCH INC Atlanta	Atlanta	Georgia	United States	30342
12	Neurological Center of N Ga	Gainesville	Georgia	United States	30501
13	Sleep Practitioners, LLC	Macon	Georgia	United States	31210
14	SleepCare Research Institute Inc	Stockbridge	Georgia	United States	30281
15	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
16	Brengle Family Medicine	Indianapolis	Indiana	United States	46260
17	Clinical Neurophysiology Services	Sterling Heights	Michigan	United States	48314
18	Clinilabs Drug Development Corporation-Feasibility	Eatontown	New Jersey	United States	07724
19	NeuroScience Research Center	Canton	Ohio	United States	44718
20	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212
21	Intrepid Research, LLC.	Cincinnati	Ohio	United States	45245
22	Ohio Sleep Medicine Institute	Dublin	Ohio	United States	43017
23	Medical University of South Carolina-Inst. of Psychiatry	Charleston	South Carolina	United States	29425
24	Bogan Sleep Consultants, LLC	Columbia	South Carolina	United States	29201
25	FutureSearch Trials of Neurology LP	Austin	Texas	United States	78731
26	FutureSearch Trials of Dallas, LLC	Dallas	Texas	United States	75230
27	Sleep Therapy Research Center	San Antonio	Texas	United States	78229
28	Road Runner Research, Ltd.	San Antonio	Texas	United States	78249
29	Comprehensive Sleep Medicine Associates	Sugar Land	Texas	United States	77478
30	EMCO Privatklinik	Bad Duerrnberg	Salzburg	Austria	5422
31	LKH Graz II, Standort Süd	Graz		Austria	8053
32	Herz Jesu Krankenhaus	Vienna		Austria	1030
33	Rudolfinerhaus	Vienna		Austria	1190
34	Anima Research Center	Alken		Belgium	3570
35	CHU Saint-Pierre/UMC Sint-Pieter	Bruxelles - Brussel		Belgium	1000
36	SGS CPU	Edegem		Belgium	2650
37	Pneumocare SRL	Erpent		Belgium	5101
38	UZ Leuven Gasthuisberg	Leuven		Belgium	3000
39	Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc	Woluwe Saint Lambert		Belgium	1200
40	Národní ústav duševního zdraví	Klecany		Czechia	250 67
41	Klinika plicnich nemoci a tuberkulozy - Fakultni nemocnice Olomouc	Olomouc		Czechia	77900
42	Universitätsklinik Gießen und Marburg GmbH	Marburg	Hessen	Germany	35043
43	Siteworks GmbH	Hannover	Niedersachsen	Germany	30449
44	Pratia \| Klinische Forschung Dresden	Dresden	Sachsen	Germany	01069
45	ADVANCED SLEEP RESEARCH BERLIN Berlin	Berlin		Germany	10117
46	KLIN FORSCHUNG HAMBURG GMBH Hamburg	Hamburg		Germany	20253
47	SOMNI BENE INSTITUT FUR MEDIZIMISCHE FORSCHUNG & SCHLAFMEDEZIN Schwerin	Schwerin		Germany	19053
48	Amphia	Breda		Netherlands	4818 CK
49	Centrum Badan Klinicznych PI-House	Gdansk		Poland	80-546
50	Osrodek Medycyny Snu Instytutu Psychiatrii i Neurologii	Warsaw		Poland	02-957
51	EMC Instytut Medyczny SA	Wroclaw		Poland	54-144
52	Hospital Universitario de La Ribera \| Neurophysiology and Sleep Department	Alzira		Spain	46600
53	Centro Medico Teknon \| Unidad de Medicina del Sueno	Barcelona		Spain	08022
54	Ciutat Sanitaria i Universitaria de la Vall d'Hebron	Barcelona		Spain	08023
55	Hospital Clinico San Carlos \| Neurophysiology Department - Sleep Unit - Menopause Sleep Disturbance	Madrid		Spain	28040
56	Hospital Universitario HM Puerta Del Sur \| Departamento de Ensayos Clinicos - Sleep Unit - Menopause Sleep Disturbance	Mostoles		Spain	28938
57	Hospital Universitario de Araba \| Santiago Campus - Unidad Sueno	Vitoria-Gasteiz		Spain	01009

Sponsors and Collaborators

Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT06112756

Other Study ID Numbers:

22423
2023-504955-28-00

First Posted:

Nov 1, 2023

Last Update Posted:

Nov 1, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Study Results

No Results Posted as of Nov 1, 2023