Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02405091 | Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia | PHASE3 | COMPLETED | 167 | — | — | Mar 1, 2015 | Mar 1, 2017 | Nov 30, 2018 | 48 | United States, Canada +1 |
| NCT02274558 | A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia | PHASE3 | COMPLETED | 234 | — | — | Oct 1, 2014 | Jul 1, 2016 | Jul 11, 2017 | 54 | United States, Canada +1 |
| NCT01733121 | NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia | PHASE2 | COMPLETED | 102 | — | — | Dec 1, 2012 | Dec 1, 2013 | Aug 10, 2017 | 22 | United States, Puerto Rico |
| NCT01688037 | NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) | PHASE2 | COMPLETED | 109 | — | — | Sep 1, 2012 | Oct 1, 2013 | Nov 8, 2017 | 51 | United States, Puerto Rico |
| NCT01393600 | NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder | PHASE2 | COMPLETED | 37 | — | — | Aug 1, 2011 | Feb 1, 2012 | Aug 10, 2017 | 11 | United States |
| NCT01267188 | Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia | PHASE2 | COMPLETED | 10 | — | — | Jan 1, 2011 | Mar 1, 2011 | Apr 20, 2011 | 1 | Canada |
Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Severity of TD symptoms assessed by AIMS dyskinesia total score (sum of items 1 through 7), as assessed by blinded central AIMS video raters. The AIMS Total Dyskinesia Score rates a total of 7 items, rating involuntary movement from 0 (no dyskinesia) to 4 (severe dyskinesia). Items 1 through 7 include facial and oral movements (Items 1-4), extremity movements (Items 5-6), and trunk movements (Item 7). The AIMS dyskinesia total score for Items 1-7 ranges from 0 to 28; a higher score reflects increased severity.
Abnormal Involuntary Movements Scale (AIMS) and Clinical Global Impression - Global Improvement of TD (CGI-TD) scale
| Arm | Type | Description |
|---|---|---|
| Dose Group 1 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily for 48 weeks |
| Dose Group 2 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily up to 48 weeks |
| NBI-98854 40 mg | EXPERIMENTAL | NBI-98854 administered as one (1) 40 mg capsule and one (1) placebo capsule, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose. |
| NBI-98854 80 mg | EXPERIMENTAL | Subjects randomized to the NBI-98854 80 mg dose will receive NBI-98854 40 mg for the first week (administered as one (1) 40 mg capsule and one (1) placebo capsule), followed by NBI-98854 80 mg administered as two (2) 40 mg capsules, taken by mouth, every morning between 7:00am - 10:00am for 5 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and continue with their current dose. |
| Placebo | EXPERIMENTAL | Placebo administered as two (2) placebo capsules, taken by mouth, every morning between 7:00am - 10:00am for 6 weeks. At the end of Week 6, subjects will enter a double-blind NBI-98854 treatment period and be randomized to either a 40 mg or 80 mg dose. Subjects re-randomized to receive NBI-98854 80 mg will receive 40 mg for the first week. |
| NBI-98854 | EXPERIMENTAL | Dose titration to determine a subject's optimal dose in the range of 25 to 75 mg NBI-98854. Dose titration is performed in increments of 25 mg. NBI-98854 administered as one (1) 25 mg capsule, two (2) 25 mg capsules, or one (1) 25 mg capsule and one (1) 50 mg capsule by mouth, taken every morning between 7:00am - 10:00am for 6 weeks. |
| NBI-98854 50 mg | EXPERIMENTAL | NBI-98854 50 mg administered as two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for 6 weeks. |
| NBI-98854 100 mg and 50 mg | EXPERIMENTAL | NBI-98854 100 mg administered as two (2) 50 mg capsules taken every morning between 7:00am - 10:00am for 2 weeks. After 2 weeks, NBI-98854 50 mg administered by two (2) 25 mg capsules by mouth, taken every morning between 7:00am - 10:00am for remaining 4 weeks. |
| NBI-98854 12.5 mg | EXPERIMENTAL | During the Cross-Over Study, subjects will be randomly assigned to receive one of the following treatment sequences: Sequence 1: Placebo once daily dose for Days 1-14 and 12.5 mg NBI-98854 once daily dose for Days 15-28. Sequence 2: 12.5 mg NBI-98854 once daily dose for Days 1-14 and placebo once daily dose for Days 15-28. |
| Name | Type | Description |
|---|---|---|
| NBI-98854 | DRUG | - |
| Placebo | DRUG | NBI-98854 placebo capsules |
Inclusion Criteria: 1. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study. 2. Female subjects must not be pregnant. 3. Have one of the following ...