Tardive Dyskinesia
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CLINICAL_TRIALS trial_result · 2021-03-10Clinical Trial Update: Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia [Phase 4]
Phase 4 trial update on the persistence of effect and safety of valbenazine for tardive dyskinesia.
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CLINICAL_TRIALS trial_result · 2021-03-01Clinical Trial Update: Reducing Involuntary Movements in Participants With Tardive Dyskinesia [Phase 3]
Phase 3 clinical trial update on reducing involuntary movements in tardive dyskinesia; results posted after completion.
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FDA approval · 2021-02-09FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)
The FDA approved a supplemental application for Austedo (deutetrabenazine) from Teva Neuroscience, Inc., indicating an approved update to th…
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FDA approval · 2021-02-01FDA Approved: GOCOVRI — Supplemental Application (Adamas Pharma, LLC)
FDA approved a supplemental application for GOCOVRI (amantadine) submitted by Adamas Pharma, LLC. The approval relates to the use of GOCOVRI…
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FDA approval · 2020-12-02FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)
FDA approves a supplemental application for Austedo (deutetrabenazine) from Teva Neuroscience, Inc.
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CLINICAL_TRIALS trial_result · 2020-06-04Clinical Trial Update: The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine [Phase 4]
Phase 4 trial update exploring potential dependence and withdrawal symptoms associated with valbenazine in tardive dyskinesia.
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FDA label_change · 2019-07-15FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)
The FDA approved Teva's supplemental application for Austedo (deutetrabenazine) to update the product labeling. This likely reflects changes…
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CLINICAL_TRIALS trial_result · 2019-03-22Clinical Trial Update: Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates [Phase 4]
Phase 4 trial evaluating varenicline for smoking cessation in schizophrenia with antipsychotic-induced neurological symptoms as correlates; …
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CLINICAL_TRIALS withdrawal · 2019-02-26Clinical Trial Update: Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia [Phase 2, Phase 3]
A clinical trial evaluating propranolol for tardive dyskinesia was withdrawn from both Phase 2 and Phase 3 stages.
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CLINICAL_TRIALS trial_result · 2019-02-15Clinical Trial Update: Safety and Efficacy of Pyridoxal 5' -Phosphate in the Treatment of Tardive Dyskinesia [Phase 2]
Phase 2 trial evaluating Pyridoxal 5'-Phosphate for tardive dyskinesia was terminated.
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FDA approval · 2019-01-10FDA Approved: INGREZZA — Supplemental Application (Neurocrine Biosciences, Inc.)
The FDA approved a supplemental application for INGREZZA (valbenazine) submitted by Neurocrine Biosciences. The action updates the drug's la…
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CLINICAL_TRIALS trial_result · 2018-12-19Clinical Trial Update: Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia [Phase 3]
A Phase 3 rollover study evaluating continuing valbenazine (NBI-98854) for tardive dyskinesia has completed and posted results in 2018.
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CLINICAL_TRIALS trial_result · 2018-11-30Clinical Trial Update: Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia [Phase 3]
Phase 3 safety and tolerability study of NBI-98854 for tardive dyskinesia has completed with results posted.
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FDA approval · 2018-08-10FDA Approved: INGREZZA — Supplemental Application (Neurocrine Biosciences, Inc.)
The FDA approved a supplemental application for INGREZZA (valbenazine) from Neurocrine Biosciences, Inc.
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FDA label_change · 2018-06-06FDA Approved: AUSTEDO — Supplemental Application (Teva Neuroscience, Inc.)
FDA approved a supplemental application for AUSTEDO (deutetrabenazine) filed by Teva Neuroscience, updating the drug's labeling.
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CLINICAL_TRIALS trial_result · 2018-04-11Clinical Trial Update: Addressing Involuntary Movements in Tardive Dyskinesia [Phase 3]
Phase 3 trial update on addressing involuntary movements in tardive dyskinesia.
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CLINICAL_TRIALS trial_result · 2018-03-20Clinical Trial Update: Aim to Reduce Movements in Tardive Dyskinesia [Phase 2, Phase 3]
A Phase 2/Phase 3 clinical trial update for an attempt to reduce movements in tardive dyskinesia by Auspex Pharmaceuticals; the study is com…
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CLINICAL_TRIALS research · 2018-02-26Clinical Trial Update: Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia. [NA]
This clinical trial update describes the evaluation of repetitive transcranial magnetic stimulation as a treatment for tardive dyskinesia. T…
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CLINICAL_TRIALS research · 2017-11-22Clinical Trial Update: Real-World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents
This clinical trial update describes a real-world screening study and registry to monitor tardive dyskinesia in patients taking antipsychoti…
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CLINICAL_TRIALS trial_result · 2017-11-08Clinical Trial Update: NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) [Phase 2]
This entry reports completion of a Phase 2 trial (KINECT) evaluating NBI-98854 for tardive dyskinesia in individuals with schizophrenia or s…
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CLINICAL_TRIALS trial_result · 2017-08-10Clinical Trial Update: NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder [Phase 2]
Phase 2 trial update for NBI-98854 (valbenazine) in tardive dyskinesia in patients with schizophrenia or schizoaffective disorder; results w…
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CLINICAL_TRIALS trial_result · 2017-08-10Clinical Trial Update: NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia [Phase 2]
The document reports the completion and posted results of a Phase 2 dose-titration trial of NBI-98854 for tardive dyskinesia.
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CLINICAL_TRIALS trial_result · 2017-07-11Clinical Trial Update: A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia [Phase 3]
Phase 3 trial results for NBI-98854 in tardive dyskinesia have been posted following completion of the study.
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CLINICAL_TRIALS trial_result · 2017-05-23Clinical Trial Update: Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia [NA]
A clinical trial evaluating deep brain stimulation for tardive dyskinesia and tardive dystonia (NCT02524886) has been terminated.
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FDA approval · 2017-04-11FDA Approved: INGREZZA — Original Application (Neurocrine Biosciences, Inc.)
FDA approved INGREZZA (valbenazine) from Neurocrine Biosciences under NDA209241, marking the original approval for the treatment of tardive …