Clinical trials: sponsored by Neurocrine Biosciences
Tardive Dyskinesia
NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or…
- Trial name
- NCT01393600
- Testing
- NBI-98854
- Where
- 11 sites in United States
- Volunteers
- 37 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily for the treatment of Tardive Dyskinesia (TD)…
- Trial name
- NCT01733121
- Testing
- NBI-98854
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 102 people
- Sponsor
- Neurocrine Biosciences
Tardive Dyskinesia
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
- Trial name
- KINECT 3 (NCT02274558)
- Testing
- NBI-98854
- Where
- 54 sites in United States, Canada and 1 more
- Volunteers
- 234 people
- Sponsor
- Neurocrine Biosciences
Tourette Syndrome
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
This is a Phase 1b, open-label, multiple-dose study of the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-98854 in a total of 36 pediatric subjects with Tourette syndrome (TS).
- Trial name
- T-FORCE (NCT02256475)
- Testing
- NBI-98854
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Neurocrine Biosciences
Congenital Adrenal Hyperplasia
Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia
This is a Phase 1, multicenter, open-label, single-dose study to evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NBI-77860 in subjects with congenital adrenal hyperplasia (CAH).
- Trial name
- NCT02349503
- Testing
- NBI-77860
- Where
- 2 sites in United States
- Sponsor
- Neurocrine Biosciences
Insomnia
An Exploratory Study of NBI-34060 Capsules and Next Day Functioning
NBI-34060 is an investigational (research) medication being studied in people with insomnia. The current study is designed to evaluate how people, who experience a nighttime awakening with difficulty returning to sleep, feel…
- Trial name
- NCT00525941
- Testing
- NBI-34060
- Where
- 4 sites in United States
- Sponsor
- Neurocrine Biosciences
Safety, Tolerability, and PK of NBI-98854 in Hepatically Impaired Subjects
Safety, Tolerability, and Pharmacokinetics of a Single Dose of NBI-98854 in Subjects With Mild,Moderate, or Severe Hepatic Insufficiency
The purpose of this research study is to: test the safety, tolerability, and pharmacokinetics (PK testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug) of a single dose of the investigational…
- Trial name
- NCT01916993
- Testing
- NBI-98854 50 mg capsule
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
The purposes of this study are to: learn about the safety of the study drug (NBI-98854); learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK testing, the study of how the body absorbs…
- Trial name
- NCT01910480
- Testing
- NBI-98854 50 mg capsule once daily, Ketoconazole 400 mg (200 mg twice daily)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Breast Cancer, Kidney Cancer
Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances directly to solid tumor cells. PURPOSE: Phase I trial to study the effectiveness of intravenous interleukin-4 PE38KDEL cytotoxin in…
- Conditions
- Breast Cancer, Kidney Cancer, Lung Cancer
- Trial name
- NCT00039052
- Testing
- interleukin-4 PE38KDEL cytotoxin
- Where
- 2 sites in United States
- Sponsor
- Neurocrine Biosciences
Brain and Central Nervous System Tumors
NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme
RATIONALE: NBI-3001 may be able to locate cancer cells and stop them from growing. This may be an effective treatment for glioblastoma multiforme.
- Trial name
- NCT00014677
- Testing
- interleukin-4 PE38KDEL cytotoxin, conventional surgery
- Where
- 4 sites in United States
- Sponsor
- Neurocrine Biosciences
Folliculogenesis
An Open-label Study of the Effects of Elagolix in Adult Premenopausal Females
This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on…
- Trial name
- NCT01403038
- Testing
- Elagolix
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- AbbVie (prior sponsor, Abbott)
Tardive Dyskinesia
Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia
The purpose of this study is to assess the safety and efficacy of three doses (12.5, 25, and 50 mg) of NBI-98854 for the treatment of the symptoms of tardive dyskinesia (TD) in subjects with schizophrenia or schizoaffective…
- Trial name
- NCT01267188
- Testing
- NBI-98854
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Neurocrine Biosciences
Type 1 Diabetes Mellitus
A Study to Evaluate NBI-6024 in Adult and Adolescent Patients With New Onset of Type 1 Diabetes Mellitus
This was a study designed to evaluate the efficacy of multiple doses of an investigational drug, NBI-6024, in adult (18 to 35 years of age) and adolescent (10 to 17 years of age) patients with new onset type 1 diabetes mellitus…
- Trial name
- NCT00873561
- Testing
- NBI-6024
- Where
- 21 sites in Canada, Czechia and 6 more
- Volunteers
- 188 people
- Sponsor
- Neurocrine Biosciences
Multiple Sclerosis
Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)
We are studying this investigational drug treatment, comparing it with placebo, to evaluate whether it is effective in reducing the number of MRI lesions with a minimum number of side effects.
- Trial name
- NCT00079495
- Testing
- NBI-5788
- Volunteers
- 150 people
- Sponsor
- Neurocrine Biosciences
Insomnia, Depression
Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression
The goal of this study is to determine whether indiplon, when administered with sertraline, improves insomnia symptoms and depressive symptoms in subjects with both insomnia and depression.
- Trial name
- NCT00232167
- Testing
- Indiplon, Sertraline
- Volunteers
- 380 people
- Sponsor
- Neurocrine Biosciences