Trial Outcomes & Findings for Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome (NCT NCT02581865)

Last Updated: 2020-05-07

Results Overview

The YGTSS is designed to rate the overall severity of motor and phonic tic symptoms across a range of dimensions: number, frequency, intensity, complexity, and interference. The YGTSS was administered by the investigator (or qualified designee) using a computer-based structured clinical interview. The TTS is the sum of the 5 motor tic items and the 5 phonic (vocal) tic items and ranges from 0 to 50, with higher scores representing greater severity

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

124 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2020-05-07

Participant Flow

This study enrolled participants (male and female) with a diagnosis of Tourette Syndrome through Diagnostic and Statistical Manual of Mental Disorders, 4th or 5th Editions (DSM-IV or -V) from approximately 40 study centers in the United States

Participant milestones

Participant milestones
Measure	Placebo Placebo administered once daily for 8 weeks	NBI-98854 40 mg Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg NBI-98854 80 mg dose will be titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
Overall Study STARTED	40	42	42
Overall Study COMPLETED	36	35	26
Overall Study NOT COMPLETED	4	7	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=39 Participants Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=41 Participants Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=40 Participants NBI-98854 80 mg dose will be titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)	Total n=120 Participants Total of all reporting groups
Age, Continuous	37.2 years n=5 Participants	34.1 years n=7 Participants	34.1 years n=5 Participants	35.1 years n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	40 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	32 Participants n=7 Participants	25 Participants n=5 Participants	80 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	39 Participants n=7 Participants	36 Participants n=5 Participants	111 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	34 Participants n=5 Participants	39 Participants n=7 Participants	34 Participants n=5 Participants	107 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native, White	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American, White	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · White, Other: German	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other: Thai/White	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Body mass index (BMI) at Screening	28.69 kg/m^2 (kilogram/meter^2) n=5 Participants	28.75 kg/m^2 (kilogram/meter^2) n=7 Participants	29.01 kg/m^2 (kilogram/meter^2) n=5 Participants	28.82 kg/m^2 (kilogram/meter^2) n=4 Participants
Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)	32.1 Score on scale n=5 Participants	31.6 Score on scale n=7 Participants	30.0 Score on scale n=5 Participants	31.2 Score on scale n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: The intent-to-treat (ITT) analysis set, that includes all randomized subjects who received at least one dose of study drug, have postbaseline safety data \& have at least one post randomization Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) value at a scheduled visit or mapped early termination (ET) visit during 8-week treatment period

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=35 Participants Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=27 Participants NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
Change From Baseline to Week 8 in the YGTSS TTS	-6.1 Least Squares Mean (Standard Error) Standard Error 1.1	-7.4 Least Squares Mean (Standard Error) Standard Error 1.7	-8.0 Least Squares Mean (Standard Error) Standard Error 1.1

SECONDARY outcome

Timeframe: Week 8

Population: the intent-to-treat (ITT) analysis set, that includes all randomized subjects who received at least one dose of study drug, have postbaseline safety data \& have at least one post randomization Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) value at a scheduled visit or mapped early termination (ET) visit during 8-week treatment period

The CGI-TS-Improvement scale is used to assess overall improvement since the initiation of study drug dosing on a 7-point scale. Each of the CGI-TS-Improvement response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=36 Participants Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=27 Participants NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8	3.2 score on a scale Standard Error 0.2	3.0 score on a scale Standard Error 0.2	2.6 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 8

The CGI-Tics-Severity scale is used to assess overall severity on a 7-point scale. Each of the CGI-Tics-Severity response categories was assigned a numerical score as follows: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patient.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=36 Participants Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=27 Participants NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score	-0.8 score on a scale Standard Error 0.2	-1.0 score on a scale Standard Error 0.2	-1.0 score on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline, Week 8

A modified RTRS was used in this study that includes short video recordings to measure 5 tic variables: number of body areas affected, frequency of motor and phonic tics, and severity of motor and phonic tics. The RTRS total score is calculated as the sum of the 5 domain scores, and ranges from 0 to 20, with higher scores representing greater severity. The final on-treatment visit was used in subjects who discontinued prior to Week 8.

Outcome measures

Outcome measures
Measure	Placebo n=39 Participants Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=41 Participants Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=40 Participants NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score	-1.9 score on a scale Standard Error 0.7	-3.0 score on a scale Standard Error 0.6	-3.6 score on a scale Standard Error 0.6

SECONDARY outcome

Timeframe: Baseline, Week 8

The YGTSS Global Tic Severity score is the sum of the YGTSS TTS and the YGTSS Impairment score and ranges from 0 to 100, with higher scores representing greater severity.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=35 Participants Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=27 Participants NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score	-15.0 score on a scale Standard Error 2.6	-16.2 score on a scale Standard Error 3.5	-19.1 score on a scale Standard Error 2.9

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The analysis population include intent-to-treat (ITT):all subjects in the safety analysis set with at least one post-randomization TTS value reported at a scheduled visit or mapped Early Termination (ET) visit during the treatment period.

The PUTS is an instrument for quantifying the premonitory urge phenomena associated with tics. It consists of 9 items, each of which is scored on a 4-point scale (1=not at all true, 2=a little true, 3=pretty much true, 4=very much true). The PUTS total score is calculated as the sum of the scores for the 9 items. The maximum possible total score is 36.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=36 Participants Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=27 Participants NBI-98854 80 mg dose titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period)
Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score	-1.2 score on a scale Standard Error 0.7	-0.8 score on a scale Standard Error 0.9	-0.6 score on a scale Standard Error 0.9

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

NBI-98854 40 mg

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

NBI-98854 80 mg

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=40 participants at risk Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=42 participants at risk Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=42 participants at risk NBI-98854 80 mg dose was titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period
Infections and infestations Septic shock	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Infections and infestations Pelvic inflammatory disease	2.5% 1/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Immune system disorders Hypersensitivity	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Infections and infestations Pneumonia streptococcal	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Renal and urinary disorders Renal failure acute	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.

Other adverse events

Other adverse events
Measure	Placebo n=40 participants at risk Placebo administered once daily for 8 weeks	NBI-98854 40 mg n=42 participants at risk Fixed dose of NBI-98854 40 mg administered once daily for 8 weeks	NBI-98854 80 mg n=42 participants at risk NBI-98854 80 mg dose was titrated in a blinded fashion (subjects will receive 40 mg for the first week followed by 80 mg for the remainder of the 8-week treatment period
Nervous system disorders Somnolence	2.5% 1/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	19.0% 8/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	21.4% 9/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Nervous system disorders Akathisia	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	23.8% 10/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Nervous system disorders Headache	5.0% 2/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	14.3% 6/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	4.8% 2/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Nervous system disorders Lethargy	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	4.8% 2/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	7.1% 3/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Nervous system disorders Sedation	2.5% 1/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	9.5% 4/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Nervous system disorders Disturbance in attention	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	7.1% 3/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
General disorders Fatigue	2.5% 1/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	11.9% 5/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	16.7% 7/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Psychiatric disorders Anxiety	2.5% 1/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	9.5% 4/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Psychiatric disorders Insomnia	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	11.9% 5/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Gastrointestinal disorders Nausea	2.5% 1/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	9.5% 4/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Gastrointestinal disorders Vomiting	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	0.00% 0/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	7.1% 3/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Infections and infestations Upper respiratory tract infection	7.5% 3/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	7.1% 3/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	4.8% 2/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.
Skin and subcutaneous tissue disorders Rash	0.00% 0/40 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	2.4% 1/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.	7.1% 3/42 • Up to 10 Weeks All TEAEs,whether observed by investigator,reported by subject,noted from lab. findings,or identified by other means, were recorded from time subject signed ICF until subject's follow-up visit(Week 10 or ET). The analysis set include all subjects who are randomized to a treatment group and dispensed study drug, with two exclusions:(a)subjects who withdraw from study \& return all previously dispensed study drug with all doses present,\&(b) subjects who have no postbaseline safety data collected.

Additional Information

Neurocrine Medical Information

Neurocrine Biosciences, Inc.

Phone: 877-641-3461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Generally, the PI has the right to publish results provided such publication does not violate confidentiality or IP provisions within the contract with the Sponsor. Prior to submission for publication or presentation of results, the PI must provide the Sponsor time for review. The Sponsor can request the PI to withhold or remove information from all publications. For a multi-center study, any publication of results by the PI shall not be made before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER