Trial · NCT02679079

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

NCT02679079, Phase 2, Completed, Neurocrine Biosciences; results first posted 2021-01-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome. Trials, record NCT02679079. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02679079

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
NCT number: NCT02679079
Status: Completed
Phases: Phase 2
Enrollment: 98 participants, actual
Lead sponsor: Neurocrine Biosciences
Conditions: Tourette Syndrome
Interventions: NBI-98854, Placebo
First posted: 2016-02-10
Last updated: 2021-01-15
Results first posted: 2021-01-15

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)	Baseline, Week 6	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
Secondary	Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6	Week 6	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.
Secondary	Participants Who Are a YGTSS TTS Responder at Week 6	Baseline, Week 6	A TTS responder is defined, on a per-visit basis, as a participant whose TTS value is reduced by at least 30% from baseline at the specified postbaseline visit.
Secondary	Change From Baseline to Week 6 in the YGTSS Impairment Score	Baseline, Week 6	The YGTSS Impairment item is used to rate impairment due to tics using the following 50-point anchored scale: 0 = None; 10 = Minimal; 20 = Mild; 30 = Moderate; 40 = Marked; 50 = Severe.
Secondary	Change From Baseline to Week 6 in the YGTSS Global Tic Severity Score	Baseline, Week 6	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.
Secondary	Change From Baseline to Week 6 in the Rush Video-based Tic Rating Scale (RTRS) Total Score	Baseline, Week 6	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 participants who discontinued prior to Week 6.
Secondary	Change From Baseline to Week 6 in the Premonitory Urge for Tics Scale (PUTS) Total Score	Baseline, Week 6	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 total score ranges from 9 to 36, with higher scores indicating a worse outcome.
Secondary	Change From Baseline to Week 6 in the Clinical Global Impression of Tics (CGI-Tics) - Severity Score	Baseline, Week 6	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.
Secondary	Participants Who Are a CGI-TS-Improvement Responder at Week 6	Week 6	A participant is classified as a CGI-TS-Improvement responder at a given visit if their CGI-TS-Improvement score is either a "1" ("very much improved") or a "2" ("much improved") at the visit.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)	Baseline, Week 6	The intent-to-treat (ITT) analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6	Week 6	The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Participants Who Are a YGTSS TTS Responder at Week 6	Baseline, Week 6	Participants with observed data in the ITT analysis set, defined as all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline to Week 6 in the YGTSS Impairment Score	Baseline, Week 6	The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 6 in the YGTSS Global Tic Severity Score	Baseline, Week 6	The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 6 in the Rush Video-based Tic Rating Scale (RTRS) Total Score	Baseline, Week 6	Participants with observed data in the ITT analysis set, defined as all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 6 in the Premonitory Urge for Tics Scale (PUTS) Total Score	Baseline, Week 6	The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Excludes those with missing PUTS data. Dose levels based on age group were prespecified to be combined within each dose arm.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 6 in the Clinical Global Impression of Tics (CGI-Tics) - Severity Score	Baseline, Week 6	The ITT analysis set included all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Score on scale	LEAST_SQUARES_MEAN
SECONDARY	Participants Who Are a CGI-TS-Improvement Responder at Week 6	Week 6	Participants with observed data in the ITT analysis set, defined as all randomized participants who received at least one dose of study drug, had postbaseline safety data, and had a baseline (Day -1) and at least one postrandomization TTS value reported at a scheduled or mapped early termination (ET) visit during the 6-week treatment period. Dose levels based on age group were prespecified to be combined within each dose arm.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)	Placebo	-8.8	Standard Error 1.5	Score on scale
Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)	NBI-98854 Low Dose	-7.3	Standard Error 1.4	Score on scale
Change From Baseline to Week 6 in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS)	NBI-98854 High Dose	-9.1	Standard Error 1.4	Score on scale
Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6	Placebo	3.4	Standard Error 0.2	Score on scale
Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6	NBI-98854 Low Dose	3.5	Standard Error 0.2	Score on scale
Clinical Global Impression of Tourette Syndrome (CGI-TS) - Improvement Score at Week 6	NBI-98854 High Dose	3.0	Standard Error 0.2	Score on scale
Participants Who Are a YGTSS TTS Responder at Week 6	Placebo	10		Participants
Participants Who Are a YGTSS TTS Responder at Week 6	NBI-98854 Low Dose	9		Participants
Participants Who Are a YGTSS TTS Responder at Week 6	NBI-98854 High Dose	15		Participants
Change From Baseline to Week 6 in the YGTSS Impairment Score	Placebo	-8.5	Standard Error 2.1	Score on scale

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	33
Overall Study	STARTED	NBI-98854 Low Dose	32
Overall Study	STARTED	NBI-98854 High Dose	33
Overall Study	ITT Analysis Set	Placebo	31
Overall Study	ITT Analysis Set	NBI-98854 Low Dose	32
Overall Study	ITT Analysis Set	NBI-98854 High Dose	32
Overall Study	COMPLETED	Placebo	29
Overall Study	COMPLETED	NBI-98854 Low Dose	30
Overall Study	COMPLETED	NBI-98854 High Dose	31
Overall Study	NOT COMPLETED	Placebo	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Placebo	3	32
other	Headache	Nervous system disorders	NBI-98854 Low Dose	6	32
other	Headache	Nervous system disorders	NBI-98854 High Dose	3	33
other	Somnolence	Nervous system disorders	Placebo	1	32
other	Somnolence	Nervous system disorders	NBI-98854 Low Dose	4	32
other	Somnolence	Nervous system disorders	NBI-98854 High Dose	3	33
other	Sedation	Nervous system disorders	Placebo	0	32
other	Sedation	Nervous system disorders	NBI-98854 Low Dose	2	32
other	Sedation	Nervous system disorders	NBI-98854 High Dose	3	33
other	Upper respiratory tract infection	Infections and infestations	Placebo	0	32

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	32
Total, all-cause mortality	NBI-98854 Low Dose	0	32
Total, all-cause mortality	NBI-98854 High Dose	0	33
Total, other adverse events	Placebo	9	32
Total, other adverse events	NBI-98854 Low Dose	15	32
Total, other adverse events	NBI-98854 High Dose	19	33
Total, serious adverse events	Placebo	1	32
Total, serious adverse events	NBI-98854 Low Dose	0	32
Total, serious adverse events	NBI-98854 High Dose	0	33

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

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