Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NBI-98854 · 10 trials · 3 indications
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.
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
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
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. |
| Adolescents Dose Group 1 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily at 0800 for 14 days. |
| Adolescents Dose Group 2 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily at 0800 for 14 days. Dosing will not commence until all safety and PK results from the adolescent dose group 1 have been reviewed to ensure there are no safety concerns and that maximum tolerated dose (MTD) has not been reached. |
| Adolescents Dose Group 3 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily at 0800 for 14 days. Dosing will not commence until all safety and PK results from the adolescent dose group 2 have been reviewed to ensure there are no safety concerns and that MTD has not been reached. |
| Children Dose Group 1 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily at 0800 for 14 days. Dosing will not commence until all safety and PK results from the adolescent dose group 1 have been reviewed to ensure there are no safety concerns and that MTD has not been reached. |
| Children Dose Group 2 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily at 0800 for 14 days. Dosing will not commence until all safety and PK results from the children dose group 1 have been reviewed to ensure there are no safety concerns and that MTD has not been reached. |
| Children Dose Group 3 | EXPERIMENTAL | Fixed dose of NBI-98854 administered once daily at 0800 for 14 days. Dosing will not commence until all safety and PK results from the children dose group 2 have been reviewed to ensure there are no safety concerns and that MTD has not been reached. |
| Healthy Volunteers | EXPERIMENTAL | single dose of NBI-98854 50 mg capsule |
| Mild Hepatic Impairment | EXPERIMENTAL | single dose of NBI-98854 50 mg capsule |
| Moderate Hepatic Impairment | EXPERIMENTAL | single dose of NBI-98854 50 mg capsule |
| Severe Hepatic Impairment | EXPERIMENTAL | single dose of NBI-98854 50 mg capsule |
| Name | Type | Description |
|---|---|---|
| NBI-98854 | DRUG | - |
| Placebo | DRUG | NBI-98854 placebo capsules |
| NBI-98854 50 mg capsule | DRUG | - |
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 ...
NBI-98854 is an investigational small molecule being studied for the treatment of Tardive Dyskinesia and Tourette Syndrome. Clinical trials have also evaluated its safety, tolerability, and pharmacokinetics in subjects with hepatic impairment. It is being developed by Neurocrine Biosciences, Inc. (NBIX).
NBI-98854 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting clinical trials to evaluate the drug's efficacy and safety in conditions such as Tardive Dyskinesia and Tourette Syndrome.
NBI-98854 is in Phase 1 of clinical development. While several Phase 2 trials have been completed, the current phase is listed as Phase 1. The drug is investigational and has not been approved by regulatory authorities. All six clinical trials associated with NBI-98854 have been completed.
NBI-98854 has been studied in six completed clinical trials, including NCT01267188, NCT01393600, NCT01688037, and NCT01733121. These trials focused on Tardive Dyskinesia in various patient populations, including those with schizophrenia or schizoaffective disorder. Additional trials have evaluated the drug in Tourette Syndrome and hepatic impairment.
NBI-98854 is also known as valbenazine. It is an investigational small molecule being developed by Neurocrine Biosciences for the treatment of Tardive Dyskinesia and Tourette Syndrome. Clinical trials have assessed its efficacy and safety in these conditions.