Trial · NCT03530293
Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
NCT03530293, Phase 2, Terminated, Neurocrine Biosciences; results first posted 2022-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome. Trials, record NCT03530293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03530293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome
- NCT number
- NCT03530293
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Neurocrine Biosciences
- Conditions
- Tourette Syndrome
- Interventions
- Valbenazine, Placebo oral capsule
- First posted
- 2018-05-21
- Last updated
- 2022-05-17
- Results first posted
- 2022-05-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Loss of Treatment Response | Randomization (Week 8, 10 or 12) through Week 36 | Loss of treatment response during the withdrawal period was defined as: 2 consecutive visits with 1) an increase in the Yale Global Tic Severity Scale (YGTSS) Total Tic Score (TTS) of greater than 35% or 7 points from the randomized withdrawal period baseline and 2) an increase in CGI-Tics-Severity score of ≥2 points from the randomized withdrawal period baseline; or discontinuation due to lack of efficacy or a treatment-emergent adverse event (TEAE) of worsening of tics. Median (lower and upper quartiles) Kaplan-Meier estimates for the time to loss of treatment response were not able to be calculated because of the low incidence of loss of treatment response events. |
| Secondary | Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the YGTSS TTS | Randomization Baseline (Week 8, 10 or 12); 8 weeks post-randomization | 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. Least-squares mean were estimated using a mixed-effects model for repeated measures. |
| Secondary | Change From Randomization Baseline to the Week 36 Visit in the YGTSS TTS | Randomization Baseline (Week 8, 10 or 12); Week 36 | 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 | Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the CGI-Tics-Severity Score | Randomization Baseline (Week 8, 10 or 12); 8 weeks post-randomization | 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 Randomization Baseline to the Week 36 Visit in the CGI-Tics-Severity Score | Randomization Baseline (Week 8, 10 or 12); Week 36 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Loss of Treatment Response | Randomization (Week 8, 10 or 12) through Week 36 | The full analysis set includes all subjects who were randomized to a treatment group and had at least one post-randomization visit where loss of treatment response was able to be assessed. | Days | MEDIAN |
| SECONDARY | Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the YGTSS TTS | Randomization Baseline (Week 8, 10 or 12); 8 weeks post-randomization | The full analysis set includes all subjects who were randomized to a treatment group and had at least one post-randomization visit where loss of treatment response was able to be assessed. Participants who do not have a TTS value at a scheduled or mapped early termination visit after randomization are not included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization Baseline to the Week 36 Visit in the YGTSS TTS | Randomization Baseline (Week 8, 10 or 12); Week 36 | The full analysis set includes all subjects who were randomized to a treatment group and had at least one post-randomization visit where loss of treatment response was able to be assessed. | units on a scale | MEAN |
| SECONDARY | Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the CGI-Tics-Severity Score | Randomization Baseline (Week 8, 10 or 12); 8 weeks post-randomization | The full analysis set includes all subjects who were randomized to a treatment group and had at least one post-randomization visit where loss of treatment response was able to be assessed. Participants who do not have a CGI-Tics-Severity value at a scheduled or mapped early termination visit after randomization are not included in the analysis. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization Baseline to the Week 36 Visit in the CGI-Tics-Severity Score | Randomization Baseline (Week 8, 10 or 12); Week 36 | The full analysis set includes all subjects who were randomized to a treatment group and hac at least one post-randomization visit where loss of treatment response was able to be assessed. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Loss of Treatment Response | Randomized Placebo | NA | 95% Confidence Interval NA to NA | Days | |
| Time to Loss of Treatment Response | Randomized Valbenazine | NA | 95% Confidence Interval NA to NA | Days | |
| Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the YGTSS TTS | Randomized Placebo | 3.8 | Standard Error 1.6 | units on a scale | |
| Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the YGTSS TTS | Randomized Valbenazine | -1.0 | Standard Error 1.7 | units on a scale | |
| Change From Randomization Baseline to the Week 36 Visit in the YGTSS TTS | Randomized Placebo | 0.6 | Standard Deviation 12.06 | units on a scale | |
| Change From Randomization Baseline to the Week 36 Visit in the YGTSS TTS | Randomized Valbenazine | 0.1 | Standard Deviation 8.21 | units on a scale | |
| Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the CGI-Tics-Severity Score | Randomized Placebo | 0.7 | Standard Error 0.2 | units on a scale | |
| Change From Randomization Baseline to the 8 Weeks Post-randomization Timepoint in the CGI-Tics-Severity Score | Randomized Valbenazine | -0.1 | Standard Error 0.2 | units on a scale | |
| Change From Randomization Baseline to the Week 36 Visit in the CGI-Tics-Severity Score | Randomized Placebo | 0.1 | Standard Deviation 0.78 | units on a scale | |
| Change From Randomization Baseline to the Week 36 Visit in the CGI-Tics-Severity Score | Randomized Valbenazine | 0.2 | Standard Deviation 1.30 | units on a scale |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-randomization | STARTED | Pre-randomization Valbenazine | 81 | |
| Pre-randomization | STARTED | Randomized Placebo | 0 | |
| Pre-randomization | STARTED | Randomized Valbenazine | 0 | |
| Pre-randomization | Safety Analysis Set | Pre-randomization Valbenazine | 80 | |
| Pre-randomization | Safety Analysis Set | Randomized Placebo | 0 | |
| Pre-randomization | Safety Analysis Set | Randomized Valbenazine | 0 | |
| Pre-randomization | COMPLETED | Pre-randomization Valbenazine | 57 | |
| Pre-randomization | COMPLETED | Randomized Placebo | 0 | |
| Pre-randomization | COMPLETED | Randomized Valbenazine | 0 | |
| Pre-randomization | NOT COMPLETED | Pre-randomization Valbenazine | 24 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events72
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 | Nausea | Gastrointestinal disorders | Pre-randomization Valbenazine | 4 | 80 | |
| other | Nausea | Gastrointestinal disorders | Randomized Placebo | 1 | 26 | |
| other | Nausea | Gastrointestinal disorders | Randomized Valbenazine | 4 | 26 | |
| other | Vomiting | Gastrointestinal disorders | Pre-randomization Valbenazine | 4 | 80 | |
| other | Vomiting | Gastrointestinal disorders | Randomized Placebo | 0 | 26 | |
| other | Vomiting | Gastrointestinal disorders | Randomized Valbenazine | 3 | 26 | |
| other | Fatigue | General disorders | Pre-randomization Valbenazine | 10 | 80 | |
| other | Fatigue | General disorders | Randomized Placebo | 1 | 26 | |
| other | Fatigue | General disorders | Randomized Valbenazine | 0 | 26 | |
| other | Irritability | General disorders | Pre-randomization Valbenazine | 6 | 80 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pre-randomization Valbenazine | 0 | 80 |
| Total, all-cause mortality | Randomized Placebo | 0 | 26 |
| Total, all-cause mortality | Randomized Valbenazine | 0 | 26 |
| Total, other adverse events | Pre-randomization Valbenazine | 41 | 80 |
| Total, other adverse events | Randomized Placebo | 12 | 26 |
| Total, other adverse events | Randomized Valbenazine | 14 | 26 |
| Total, serious adverse events | Pre-randomization Valbenazine | 1 | 80 |
| Total, serious adverse events | Randomized Placebo | 2 | 26 |
| Total, serious adverse events | Randomized Valbenazine | 2 | 26 |
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03530293
GET https://conductscience.org/api/trials/v1/NCT03530293/flow?page=2