A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause

Hot Flashes Clinical Trial

— Skylight 4  

Official title:

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Clinical Study to Investigate the Long-Term Safety of Fezolinetant in Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003389
• Other study ID #: 2693-CL-0304
• Secondary ID: 2019-000275-16
• Status: Completed
• Phase: Phase 3
• Start date: July 10, 2019
• Est. completion date: January 4, 2022

Study information

• Verified date: September 2023
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life.

The purpose of this study was to find out how safe it is for these women to take fezolinetant in long term (up to 52 weeks). To do that, the study looked at the number and severity of the "adverse events." Those were the side effects that study participants had while they were in the study.

The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo was a dummy treatment that looked like medicine but did not have any medicine in it.) Women in this study were picked for 1 of the 3 study treatments by chance alone. The study participants took study treatment for 52 weeks.

This study was "double-blinded." That means that the study participants and the study doctors did not know who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo).

At weeks 2 and 4 and then once a month, the study participants went to the hospital or clinic for a check-up. They were asked about medications, side effects and how they felt. Other checks included physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine were collected for laboratory tests. At some study visits, study participants completed questionnaires that were about their quality of life. At the first and last study visits, they had a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA created pictures of the inside of these areas with low-dose x-rays. (The dose was approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still had their uterus had 2 more tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. This test involved removing a small amount of tissue from the inside lining of the uterus. The tissue was then checked under a microscope. The other test was transvaginal ultrasound. It used sound waves to create pictures of the organs in the pelvis. The sound waves were transmitted by a probe (transducer), which was placed inside the vagina. Study participants might have had a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not had this test done in the last 12 months had it done at the first study visit. They had done at the last study visit if they were due for their screening mammogram and their own doctor agreed.

The last check-up at the hospital or clinic was at 3 weeks after the last dose of study treatment.

Description:

This study consisted of a screening period and a 52 week treatment period. Safety follow up occurred 3 weeks after the last dose of study drug.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1831
• Est. completion date: January 4, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject has a body mass index = 18 kg/m^2 and = 38 kg/m^2.

• Subject must be seeking treatment or relief for vasomotor symptoms (VMS) associated with menopause and confirmed as menopausal per 1 of the following criteria at the screening visit:

• Spontaneous amenorrhea for = 12 consecutive months

• Spontaneous amenorrhea for = 6 months with biochemical criteria of menopause (follicle stimulating hormone > 40 IU/L), or

• Having had bilateral oophorectomy = 6 weeks prior to the screening visit.

• Subject is seeking treatment for relief for VMS associated with menopause.

• Subject is in good general health as determined on the basis of medical history and general physical examination, including a bimanual clinical pelvic examination and clinical breast examination devoid of relevant clinical findings, performed at the screening visit; hematology and biochemistry parameters; pulse rate and/or blood pressure; and ECG within the reference range for the population studied, or showing no clinically relevant deviations.

• Subject has documentation of a normal/negative or no clinically significant mammogram findings (obtained at screening or within the prior 12 months of study enrollment). Appropriate documentation includes a written report or an electronic report indicating normal/negative or no clinically significant mammographic findings.

• Subject is willing to undergo a transvaginal ultrasound (TVU) to evaluate the uterus and ovaries at screening and at week 52 end of treatment (EOT). For subjects who are withdrawn from the study prior to completion, a TVU should be collected at the early discontinuation (ED) visit.

• Subject is willing to undergo an endometrial biopsy at screening and at week 52 (EOT) or the ED visit for subjects who are withdrawn from the study prior to completion, and any time during the study in the case of uterine bleeding. The endometrial biopsy obtained at screening must be considered evaluable.

• Subject has documentation of a normal or not clinically significant Papanicolaou (Pap) test (or equivalent cervical cytology) within the previous 12 months or at screening.

• Subject has a negative urine pregnancy test at screening.

• Subject has a negative serology panel (i.e., negative hepatitis B surface antigen, negative hepatitis C virus antibody and negative human immunodeficiency virus antibody screens) at screening.

• Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

• Subject uses a prohibited therapy (strong or moderate cytochrome P450 [CYP] 1A2 inhibitors, hormone replacement therapy [HRT], hormonal contraceptive, any treatment for VMS [prescription, over the counter or herbal]) or is not willing to wash out and discontinue such drugs for the full extent of the study.

• Subject has a known substance abuse or alcohol addiction within 6 months of screening.

• Subject has previous or current history of a malignant tumor, except for basal cell carcinoma.

• Subject's systolic blood pressure is = 130 mmHg or diastolic blood pressure is = 80 mmHg based on the average of 2 to 3 readings, on at least 2 different occasions within the screening period.

• Subjects who do not meet these criteria may be re-assessed after initiation or review of antihypertensive measures.

• Subjects with a medical history of hypertension can be enrolled once they are medically clear (stable and compliant).

• Subject has a history of severe allergy, hypersensitivity or intolerance to drugs in general, including the study drug and any of its excipients.

• Subject has an unacceptable result from the TVU assessment at screening, i.e., full length of endometrial cavity cannot be visualized or presence of a clinically significant finding.

• Subject has an endometrial biopsy confirming presence of disordered proliferative endometrium, endometrial hyperplasia, endometrial cancer, or other clinically significant findings at screening.

• Subject has a history within the last 6 months of undiagnosed uterine bleeding.

• Subject has a history of seizures or other convulsive disorders.

• Subject has a medical condition or chronic disease (including history of neurological [including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary [e.g., moderate asthma], endocrine or gynecological disease) or malignancy that could confound interpretation of the study outcome.

• Subject has active liver disease, jaundice or elevated liver aminotransferases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]), elevated total or direct bilirubin, elevated international normalized ratio (INR), or elevated alkaline phosphatase (ALP). Patients with mildly elevated ALT or AST up to 1.5 times the upper limit of normal (ULN) can be enrolled if total and direct bilirubin are normal. Patients with mildly elevated ALP (up to 1.5 x ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Patients with Gilbert's syndrome with elevated total bilirubin may be enrolled as long as direct bilirubin, hemoglobin and reticulocytes are normal.

• Subject has creatinine > 1.5 x ULN; or estimated glomerular filtration rate using the Modification of Diet in Renal Disease formula = 59 mL/min per 1.73 m^2 at the screening visit.

• Subject has a history of suicide attempt or suicidal behavior within the last 12 months or has suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale [C-SSRS]), or who is at significant risk to commit suicide, as assessed at screening and at the time of visit 2 (randomization).

• Subject has previously been enrolled in a clinical trial with fezolinetant.

• Subject is participating concurrently in another interventional study or participated in an interventional study within 28 days prior to screening, or received any investigational drug within 28 days or within 5 half-lives prior to screening, whichever is longer.

• Subject is unable or unwilling to complete the study procedures.

• Subject has any condition which makes the subject unsuitable for study participation.

• Subject has had a partial or full hysterectomy.

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• fezolinetant
administered orally
• placebo
administered orally

Locations

Country	Name	City	State
Canada	Site CA15005	Brampton	Ontario
Canada	Site CA15006	Burlington	Ontario
Canada	Site CA15012	Levis	Quebec
Canada	Site CA15004	Point Claire	Quebec
Canada	Site CA15002	Quebec
Canada	Site CA15009	Quebec
Canada	Site CA15010	Sarnia	Ontario
Canada	Site CA15003	Sherbrooke	Quebec
Canada	Site CA15007	Toronto	Ontario
Canada	Site CA15001	Victoriaville	Quebec
Czechia	Site CZ42001	Olomouc
Czechia	Site CZ42003	Olomouc
Czechia	Site CZ42010	Pisek
Czechia	Site CZ42009	Praha 2
Czechia	Site CZ42005	Tabor 3
Czechia	Site CZ42008	Vodnany	Jihocesky
Latvia	Site LV37101	Riga
Latvia	Site LV37102	Riga
Poland	Site PL48004	Bialystok
Poland	Site PL48005	Bydgoszcz
Poland	Site PL48002	Katowice
Poland	Site PL48019	Katowice
Poland	Site PL48006	Lublin
Poland	Site PL48014	Lublin
Poland	Site PL48016	Poznan
Poland	Site PL48010	Szczecin
Poland	Site PL48020	Warsaw
Poland	Site PL48003	Warszawa
Poland	Site PL48007	Warszawa
Spain	Site ES34005	Centelles
Spain	Site ES34002	Madrid
Ukraine	Site UA38006	Kiev
Ukraine	Site UA38004	Zaporizhzhya	Zaporizka Oblast
United Kingdom	Site GB44005	Corby	Northamptonshire
United Kingdom	Site GB44004	Kenilworth	Warwickshire
United Kingdom	Site GB44006	Middlesex
United Kingdom	Site GB44007	Romford
United Kingdom	Site GB44001	Shipley
United Kingdom	Site GB44008	Sidcup	Kent
United Kingdom	Site GB44003	Wokingham	Berkshire
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Bosque Women's Care	Albuquerque	New Mexico
United States	SEC Clinical Research	Andalusia	Alabama
United States	Agile Clinical Research Trials, LLC	Atlanta	Georgia
United States	Tekton Research - Georgetown	Austin	Texas
United States	Pharmasite Research Inc	Baltimore	Maryland
United States	Gadolin Research, LLC	Beaumont	Texas
United States	Hassman Research Institute, LLC	Berlin	New Jersey
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama
United States	Investigators Research Group, Llc	Brownsburg	Indiana
United States	DiscoveResarch, Inc.	Bryan	Texas
United States	Alliance Research Inc	Canoga Park	California
United States	Hope Research Institute	Canoga Park	California
United States	Womens Health USA, Inc.	Champaign	Illinois
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Chattanooga GYN-Oncology	Chattanooga	Tennessee
United States	WR Clinsearch, LLC	Chattanooga	Tennessee
United States	CTI	Cincinnati	Ohio
United States	Greater Cincinnati OB/GYN	Cincinnati	Ohio
United States	Olympian Clinical Research	Clearwater	Florida
United States	Aventiv Research, Inc.	Columbus	Ohio
United States	Complete Healthcare For Women	Columbus	Ohio
United States	Precision Clinical Research	Coral Springs	Florida
United States	Avant Research Associates, LLC	Crowley	Louisiana
United States	Nature Coast Clinical Research	Crystal River	Florida
United States	iResearch Atlanta LLC	Decatur	Georgia
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Downtown Women's Health Care	Denver	Colorado
United States	Horizons Clincial Research Center LLC	Denver	Colorado
United States	Universal Axon Clinical Research	Doral	Florida
United States	NuDirections Clinical Research	Duluth	Georgia
United States	Carolina women's research and wellness center	Durham	North Carolina
United States	Hwc Women's Research Center	Englewood	Ohio
United States	Achieve Clinical Research, LLC	Ensley	Alabama
United States	OB-GYN Associates	Erie	Pennsylvania
United States	MediSphere Medical Research	Evansville	Indiana
United States	Lillestol Research, LLC	Fargo	North Dakota
United States	Carolina Insitute for Clinical Research	Fayetteville	North Carolina
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Clinical Physiology Associates	Fort Myers	Florida
United States	Florida Medical Research	Gainesville	Florida
United States	Unified Women's Clinical Research	Greensboro	North Carolina
United States	Vital Pharma Research Inc.	Hialeah	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Advances in Health	Houston	Texas
United States	Centex Studies, Inc.	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Protenium Clinical Research, LLC	Hurst	Texas
United States	Rosemark Women Care Specialists	Idaho Falls	Idaho
United States	The Healing Sanctuary, LLC	Idaho Falls	Idaho
United States	The Clinical Trial Center LLC	Jenkintown	Pennsylvania
United States	Health Awareness	Jupiter	Florida
United States	Grossmont Center for Clinical Research	La Mesa	California
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Altus Research	Lake Worth	Florida
United States	FMC Science	Lampasas	Texas
United States	Clinical Research Center of Nevada (CRCN)	Las Vegas	Nevada
United States	Dr.R. Garn Mabey, MD,Office Of	Las Vegas	Nevada
United States	Excel Clinical Research, LLC	Las Vegas	Nevada
United States	Office Of Edmond Pack, Md	Las Vegas	Nevada
United States	Lawrence OBGYN Associates	Lawrenceville	New Jersey
United States	Downtown L.A. Research Center, Inc.	Los Angeles	California
United States	National Research Institute - Panorama	Los Angeles	California
United States	Praetorian Pharmaceutical Research	Marrero	Louisiana
United States	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee
United States	Medical Research Center of Memphis, LLC	Memphis	Tennessee
United States	Mesa Obstetricians and Gynecologists	Mesa	Arizona
United States	Medpharmics, LLC	Metairie	Louisiana
United States	Southern Clinical Research Associates	Metairie	Louisiana
United States	Florida International Research Center	Miami	Florida
United States	LCC Medical Research Institute, LLC	Miami	Florida
United States	Med Research Of Florida, LLC	Miami	Florida
United States	Medical Research Center of Miami II	Miami	Florida
United States	Medical Research Centers of South Florida, Inc.	Miami	Florida
United States	New Age Medical Research Corporation	Miami	Florida
United States	Spotlight research center	Miami	Florida
United States	Montana Medical Research Inc	Missoula	Montana
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	International Clinical Research	Murfreesboro	Tennessee
United States	EPIC Medical Research	Murray	Utah
United States	Coastal Connecticut Research, LLC	New London	Connecticut
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Health Research of Hampton Roads Inc	Newport News	Virginia
United States	Neuro-Behavioral Clinical Research, Inc	North Canton	Ohio
United States	Healthcare Clinical Data Inc	North Miami	Florida
United States	Affinity Clinical Research Institute	Oak Brook	Illinois
United States	Excell Research	Oceanside	California
United States	Sensible Healthcare LLC	Ocoee	Florida
United States	Quality Clinical Research, Inc	Omaha	Nebraska
United States	Bioclinica Research	Orlando	Florida
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Cornerstone Research Institute	Orlando	Florida
United States	Omega Research Consultants	Orlando	Florida
United States	Ormond Medical Arts Pharmaceutical Research Center	Ormond Beach	Florida
United States	Sunset Point Medical Associates	Palm Harbor	Florida
United States	Philadelphia Clinical Research, LLC	Philadelphia	Pennsylvania
United States	Medpharmics LLC	Phoenix	Arizona
United States	Precision Trials	Phoenix	Arizona
United States	Radiant Research	Pinellas Park	Florida
United States	ClinRx Research	Plano	Texas
United States	St. Johns Center for Clinical Research	Ponte Vedra	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Health Awareness	Port Saint Lucie	Florida
United States	Unified Women's Clinical Research	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Infinite Clinical Trials	Riverdale	Georgia
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Clinical Trials Research	Sacramento	California
United States	Northern California Research	Sacramento	California
United States	Saginaw Valley Medical Research Group, Llc	Saginaw	Michigan
United States	Advanced Clinical Research-Old Farm OB/GYN (Utah)	Salt Lake City	Utah
United States	Wasatch Clinical Research, LLC	Salt Lake City	Utah
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Wake Research Associates, LLC	San Diego	California
United States	Women's Healthcare Affiliates	San Diego	California
United States	WR-Mount Vernon Clinical Research	Sandy Springs	Georgia
United States	CITrials, Inc	Santa Ana	California
United States	Northeast Clinical Research Centers, Inc.	Schertz	Texas
United States	Seattle Women's: Health, Research, Gynecology	Seattle	Washington
United States	Frontier Clinical Research	Smithfield	Pennsylvania
United States	Georgia Clinical Research	Snellville	Georgia
United States	Excel Clinical Research, LLC	Sugar Land	Texas
United States	Precision Clinical Research	Sunrise	Florida
United States	GCP Clinical Research, LLC	Tampa	Florida
United States	Premier Medical Associates	The Villages	Florida
United States	Millennium Clinical Trials	Thousand Oaks	California
United States	Del Sol Research Management	Tucson	Arizona
United States	Eclipse Clinical Research	Tucson	Arizona
United States	Visions Clinical Research - Tuscon	Tucson	Arizona
United States	Women's Medical Group of Upland	Upland	California
United States	Bayview Research Group	Valley Village	California
United States	Tidewater Clinical Research, Inc.	Virginia Beach	Virginia
United States	Emerson Clinical Research institute	Washington	District of Columbia
United States	Bay State Clinical Trials, Inc.	Watertown	Massachusetts
United States	Circuit Clinical	West Seneca	New York
United States	Cypress Medical Research Center	Wichita	Kansas
United States	Upstate Clinical Research Associates LLC	Williamsville	New York
United States	Unified Women's Clinical Research	Winston-Salem	North Carolina
United States	Clinical Research of Central Florida	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Latvia,  Poland,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	An AE is any untoward medical occurrence in a participant administered a study drug, & which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign, symptom, or disease temporally associated with the use of medicinal product (MP) whether or not considered related to MP. An AE is considered "serious" if it results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization, hospitalization for treatment/observation/examination caused by AE is to be considered as serious, discontinuation due to increases in liver enzymes, other medically important events. A TEAE is defined as an AE observed after starting administration of study drug & 21 days after the last dose of study drug.	From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)
Primary	Number of Participants With Mild, Moderate and Severe TEAE	An adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal product. A TEAE is defined as an AE observed after starting administration of the study drug and 21 days after the last dose of study drug. Severity of AE we were classified as Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; and Severe: Inability to perform daily activities.	From first dose of study drug until 21 days after last dose of study drug (Up to 55 weeks)
Primary	Percentage of Participants With Endometrial Hyperplasia	Endometrial hyperplasia was confirmed from the endometrial biopsy report.	Baseline Up to 52 weeks
Primary	Percentage of Participants With Endometrial Cancer	Endometrial cancer was confirmed from the endometrial biopsy report.	Baseline Up to 52 weeks
Secondary	Change From Baseline in Endometrial Thickness at Week 52	Endometrial thicness was obtained from the transvaginal ultrasound. The endometrium was measured in the long axis or sagittal plane. The measurement was of the thickest echogenic area from 1 basal endometrial interface across the endometrial canal to the other basal surface.	Baseline and week 52
Secondary	Percentage of Participants With Disordered Proliferative Endometrium	Disordered proliferative endometrium was confirmed from the endometrial biopsy report.	Baseline Up to 52 weeks
Secondary	Change From Baseline in Bone Mineral Density (BMD) at Hip at Week 52	Changes in BMD hip was assessed by dual-energy X-ray absorptiometry (DXA) scan.	Baseline and week 52
Secondary	Change From Baseline in Trabecular Bone Score (TBS) at Hip at Week 52	TBS was a bone texture assessment that serves as a substitute for bone microarchitecture and predicts fracture risk independent of BMD and clinical risk factors. The DXA imaging was processed and analyzed as it would normally be and then evaluated using an automated algorithm to determine the TBS. T-score =1.350 was considered to be normal; T-score between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and T-score =1.200 defines degraded microarchitecture.	Baseline and week 52
Secondary	Change From Baseline in BMD at Spine at Week 52	Changes in BMD spine was assessed by DXA scan.	Baseline and week 52
Secondary	Change From Baseline in TBS at Spine at Week 52	TBS was a bone texture assessment that serves as a substitute for bone microarchitecture and predicts fracture risk independent of BMD and clinical risk factors. The DXA imaging was processed and analyzed as it would normally be and then evaluated using an automated algorithm to determine the TBS. T-score =1.350 was considered to be normal; T-score between 1.200 and 1.350 is considered to be consistent with partially degraded microarchitecture; and T-score =1.200 defines degraded microarchitecture.	Baseline and week 52
Secondary	Number of Participants With Suicidal Ideation and/or Behaviour as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS assessed the risk for suicidal behavior and suicide ideation. Participants responded as "Yes" or "No" 10 items. Suicidal ideation (1. Wish to be dead; 2. Non-specific active suicidal thoughts; 3. Active suicidal ideation with any methods (not plan) without intent to act; 4. Active suicidal ideation with some intent to act, without specific plan; 5. Active suicidal ideation with specific plan and intent; ). Suicidal behaviour (1. Preparatory acts or behavior 2. Aborted attempt 3. Interrupted attempt 4. Actual attempt 5. Completed suicide). Participants with 'Yes' to any one of the above 10 questions for suicidal ideation and behavior were reported.	Baseline, week 12, week 24, week 52 and follow-up (week 55)
Secondary	Number of Participants With Self-injurious Behavior Without Suicidal Intent as Assessed by C-SSRS	The C-SSRS assessed the risk for Self-injurious Behavior without Suicidal Intent. Question was asked "Has participant engaged in Non-Suicidal Self-Injurious Behavior?". Participants with 'yes' to the question were reported.	Baseline, week 12, week 24, week 52 and follow-up (week 55)

External Links

•   Link Description: Link to plain language summary of the study on the Trial Results Summaries website.
•   Link Description: Link to results and other applicable study documents on the Astellas Clinical Trials website.