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Also known as Valbenazine Oral Capsule
Valbenazine · 11 trials · 8 indications
The TMC is part of the motor assessment of the UHDRS and measures chorea in 7 different body parts including the face, oral-buccal-lingual region, trunk and each limb independently. The TMC score is the sum of the individual scores and ranges from 0 to 28. A decrease in TMC scores indicates improvement in chorea symptoms.
Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
A clinician-administered scale assessing OCD severity that will be used at all 8 visits. Total scores range from 0-50. Higher scores indicate worse outcomes.
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores range from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 12 weeks.
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.
A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing.
| Arm | Type | Description |
|---|---|---|
| Valbenazine | EXPERIMENTAL | Capsule, administered orally once daily. |
| Placebo | PLACEBO_COMPARATOR | Placebo dosed for 14 weeks (double-blind treatment period) followed by open-label valbenazine treatment. Participants may opt to enter an open-label valbenazine treatment extension phase. |
| Vesicular monoamine transporter 2 (VMAT2) inhibitor | EXPERIMENTAL | Valbenazine once daily |
| Valbenazine followed by placebo | OTHER | Following baseline measures, 50% of subjects will receive valbenazine (initially 40mg per day for 2 weeks and then 80mg per day for 4 weeks). This will be followed by a 2-week washout period and then 6 weeks of being assigned to the other agent. Participants will be assessed at baseline and every 2 weeks during the remainder of the study period. |
| Placebo followed by valbenazine | OTHER | Following baseline measures, 50% of subjects will receive inactive placebo for 6 weeks. This will be followed by a 2-week washout period and then 6 weeks of being assigned to the other agent (initially 40mg per day for 2 weeks and then 80mg per day for 4 weeks). Participants will be assessed at baseline and every 2 weeks during the remainder of the study period. |
| Valbenazine (Children) | EXPERIMENTAL | Children (6 to 11 years of age) received valbenazine 10 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 20 mg or continue with the participant's current dose for the remainder of the treatment period. |
| Valbenazine (Adolescents) | EXPERIMENTAL | Adolescents (12 to 17 years of age) received valbenazine 20 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 40 mg or continue with the participant's current dose for the remainder of the treatment period. |
| Valbenazine (Adults) | EXPERIMENTAL | Adults (18 to 64 years of age) received valbenazine 40 mg once daily for 4 weeks. At the end of Week 4, investigators could escalate the dose to 80 mg or continue with the participant's current dose for the remainder of the treatment period. |
| Name | Type | Description |
|---|---|---|
| Valbenazine | DRUG | vesicular monoamine transporter 2 (VMAT2) inhibitor |
| Placebo | DRUG | Capsule, administered once daily orally or via gastrostomy/gastrojejunostomy tube |
| Valbenazine Oral Capsule | DRUG | Participants randomized to active treatment will be given a starting dose of 40mg of valbenazine , which may be escalated to 80mg to achieve an optimal dose of the medication for each subject. |
| Placebo Oral capsule | OTHER | Participants randomized to placebo will be given a capsule that is the same shape and color as the active medication and will subject to the same dose escalation requirements as the other arm but will receive placebo during the treatment period. |
Key Inclusion Criteria: * Participated in Study NBI-98854-HD3006 and completing dosing through the Week 156 visit; or were actively participating, receiving study treatment, and completed an early termination visit Study NBI-98854-HD3006 at the time of the study closure at sites in Canada. * Partic...
Valbenazine is an investigational small molecule in Phase 3 development for several neurological and psychiatric conditions, including tardive dyskinesia, trichotillomania (hair-pulling disorder), dyskinesia, obsessive-compulsive disorder, chorea associated with Huntington disease, and schizophrenia. It is being studied as an adjunctive treatment for schizophrenia.
Valbenazine is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety across multiple indications.
Valbenazine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 3 trials have been completed, and one active trial is ongoing, according to the clinical trial data.
Valbenazine has been studied in several Phase 3 trials, including NCT02736955 for tardive dyskinesia, NCT04400331 for chorea associated with Huntington disease, NCT05110157 for schizophrenia, and NCT05206513 for dyskinesia due to cerebral palsy. These trials have been completed, with total enrollment of 442 participants across studies.
Yes, Valbenazine Oral Capsule is another name for Valbenazine. The drug is being developed in an oral capsule formulation by Neurocrine Biosciences for the treatment of various neurological and psychiatric disorders.