Trial · NCT02581865
Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome
NCT02581865, Phase 2, Completed, Neurocrine Biosciences; results first posted 2020-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome. Trials, record NCT02581865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02581865
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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 Adults With Tourette Syndrome
- NCT number
- NCT02581865
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tourette Syndrome
- Interventions
- NBI-98854, Placebo
- First posted
- 2015-10-21
- Last updated
- 2020-05-07
- Results first posted
- 2020-05-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 8 in the YGTSS TTS | Baseline, Week 8 | 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 Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8 | Week 8 | 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 | Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score | 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. |
| Secondary | Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score | 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. |
| Secondary | Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score | 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. |
| Secondary | Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score | Baseline, Week 8 | 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. |
Source ClinicalTrials.gov
Outcomes6
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 8 in the YGTSS TTS | Baseline, Week 8 | 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 | Least Squares Mean (Standard Error) | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8 | Week 8 | 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 | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score | Baseline, Week 8 | 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 | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score | Baseline, Week 8 | 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 | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 in the YGTSS Global Tic Severity Score | Baseline, Week 8 | 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 | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 8 in the Premonitory Urge for Tics Scale (PUTS) Total Score | Baseline, Week 8 | 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. | score on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 8 in the YGTSS TTS | Placebo | -6.1 | Standard Error 1.1 | Least Squares Mean (Standard Error) | |
| Change From Baseline to Week 8 in the YGTSS TTS | NBI-98854 40 mg | -7.4 | Standard Error 1.7 | Least Squares Mean (Standard Error) | |
| Change From Baseline to Week 8 in the YGTSS TTS | NBI-98854 80 mg | -8.0 | Standard Error 1.1 | Least Squares Mean (Standard Error) | |
| Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8 | Placebo | 3.2 | Standard Error 0.2 | score on a scale | |
| Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8 | NBI-98854 40 mg | 3.0 | Standard Error 0.2 | score on a scale | |
| Clinical Global Impression of Change Tourette Syndrome (CGI-TS)-Improvement Score at Week 8 | NBI-98854 80 mg | 2.6 | Standard Error 0.1 | score on a scale | |
| Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score | Placebo | -0.8 | Standard Error 0.2 | score on a scale | |
| Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score | NBI-98854 40 mg | -1.0 | Standard Error 0.2 | score on a scale | |
| Change From Baseline to Week 8 in the Clinical Global Impression of Tics (CGI-Tics)-Severity Score | NBI-98854 80 mg | -1.0 | Standard Error 0.1 | score on a scale | |
| Change From Baseline to Last Visit in the Rush Video-based Tic Rating Scale (RTRS) Total Score | Placebo | -1.9 | Standard Error 0.7 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 40 | |
| Overall Study | STARTED | NBI-98854 40 mg | 42 | |
| Overall Study | STARTED | NBI-98854 80 mg | 42 | |
| Overall Study | COMPLETED | Placebo | 36 | |
| Overall Study | COMPLETED | NBI-98854 40 mg | 35 | |
| Overall Study | COMPLETED | NBI-98854 80 mg | 26 | |
| Overall Study | NOT COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | NBI-98854 40 mg | 7 | |
| Overall Study | NOT COMPLETED | NBI-98854 80 mg | 16 |
Source ClinicalTrials.gov
Adverse events60
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 | Events |
|---|---|---|---|---|---|---|
| other | Somnolence | Nervous system disorders | Placebo | 1 | 40 | |
| other | Somnolence | Nervous system disorders | NBI-98854 40 mg | 8 | 42 | |
| other | Somnolence | Nervous system disorders | NBI-98854 80 mg | 9 | 42 | |
| other | Akathisia | Nervous system disorders | Placebo | 0 | 40 | |
| other | Akathisia | Nervous system disorders | NBI-98854 40 mg | 1 | 42 | |
| other | Akathisia | Nervous system disorders | NBI-98854 80 mg | 10 | 42 | |
| other | Headache | Nervous system disorders | Placebo | 2 | 40 | |
| other | Headache | Nervous system disorders | NBI-98854 40 mg | 6 | 42 | |
| other | Headache | Nervous system disorders | NBI-98854 80 mg | 2 | 42 | |
| other | Lethargy | Nervous system disorders | Placebo | 0 | 40 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 40 |
| Total, all-cause mortality | NBI-98854 40 mg | 0 | 42 |
| Total, all-cause mortality | NBI-98854 80 mg | 0 | 42 |
| Total, other adverse events | Placebo | 8 | 40 |
| Total, other adverse events | NBI-98854 40 mg | 22 | 42 |
| Total, other adverse events | NBI-98854 80 mg | 32 | 42 |
| Total, serious adverse events | Placebo | 1 | 40 |
| Total, serious adverse events | NBI-98854 40 mg | 1 | 42 |
| Total, serious adverse events | NBI-98854 80 mg | 2 | 42 |
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.
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.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02581865
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