Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04092686
- Testing
- SEP-363856 75mg, SEP-363856 100mg
- Where
- 53 sites in United States, Bulgaria and 5 more
- Volunteers
- 464 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Keratoconjunctivitis Sicca
A 1-Year Study in Multiple Clinics Testing Rebamipide Eye Drops for Dry Eye Compared With a Placebo
The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
- Trial name
- NCT00201981
- Testing
- Rebamipide 1%, Rebamipide 2%
- Where
- 63 sites in United States
- Volunteers
- 755 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832.
- Trial name
- NCT07542847
- Testing
- OPC-167832, Itraconazole, Carbamazepine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multiple Myeloma
Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide Maintenance
A number of strategies have been proposed to improve the outcome of ASCT. The three main strategies are to incorporate novel agents into the induction regimen, using maintenance therapy following ASCT and the final strategy is to…
- Trial name
- BuMelMCRN001 (NCT01702831)
- Testing
- Busulfan, Melphalan, Lenalidomide
- Where
- 10 sites in Canada
- Volunteers
- 78 people
- Sponsor
- University Health Network, Toronto
Schizophrenia
Intramuscular Depot Formulation of Aripiprazole as Maintenance Treatment in Patients With Schizophrenia
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into…
- Trial name
- ASPIRE (NCT00706654)
- Testing
- Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally, Aripiprazole depot 25 or 50 mg
- Where
- 98 sites in United States, Austria and 13 more
- Volunteers
- 937 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
A Study to Evaluate Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Multiple Doses of VIS954
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult participants.
- Trial name
- NCT06937593
- Testing
- VIS954
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo.
- Trial name
- NCT04072354
- Testing
- SEP-363856 50mg, SEP-363856 75mg
- Where
- 53 sites in United States, Bulgaria and 4 more
- Volunteers
- 463 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Adult ADHD
Study of Flexible Doses of the Triple Reuptake Inhibitor EB-1020 Sustained Release (SR) in the Treatment of Adult Males With Attention-Deficit Hyperactivity Disorder
This was a Phase 2 exploratory study to evaluate the efficacy and safety of EB-1020 SR (centanafadine sustained release [CTN SR]) in treating participants who met Diagnostic and Statistical Manual of Mental Disorders, Fourth…
- Trial name
- NCT01939353
- Testing
- CTN SR
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment…
- Trial name
- JUNIPER (NCT05536414)
- Testing
- Centanafadine, Escitalopram
- Where
- 62 sites in United States
- Volunteers
- 337 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit/Hyperactivity Disorder
A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.
To evaluate long-term safety exposure
- Trial name
- NCT05279313
- Testing
- Centanafadine Hydrochloride
- Where
- 86 sites in United States, Canada and 1 more
- Volunteers
- 680 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00332241
- Testing
- Aripiprazole
- Where
- 9 sites in United States
- Volunteers
- 98 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Behavioral Symptoms, Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00337571
- Testing
- Aripiprazole
- Where
- 31 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Disinhibition Syndrome
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
- Trial name
- NCT02534038
- Testing
- AVP-786
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.
- Trial name
- NCT02477670
- Testing
- AVP-786
- Where
- 17 sites in United States
- Volunteers
- 145 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multiple Myeloma
IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.
- Trial name
- NCT01009840
- Testing
- IV busulfan, bortezomib, Autologous Hematopoietic Stem Cell Transplant (HSCT)
- Where
- 13 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Trial name
- NCT00277212
- Testing
- Lamotrigine + Aripiprazole
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 1,169 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Phenylketonuria (PKU)
A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria
The goal of this Phase 2, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adolescents (12 to less than 18 years of age) with PKU.
- Trial name
- NCT06637514
- Testing
- JNT-517 Tablet
- Where
- 7 sites in United States, Australia
- Volunteers
- 14 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants
The purpose of this study is to determine the absorption, metabolism and excretion of [14C]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a…
- Trial name
- NCT07573449
- Testing
- [14C]-JNT-517
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
ADHD, Anxiety
P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety
Primary: To evaluate the efficacy of CTN in adults ages with ADHD and comorbid anxiety (AISRS) Key Secondary: To assess the efficacy of CTN in adults ages with ADHD and comorbid anxiety
- Conditions
- ADHD, Anxiety, Generalized Anxiety, Social Anxiety Disorder
- Trial name
- NCT06973577
- Testing
- Centanafadine
- Where
- 47 sites in United States, Puerto Rico
- Volunteers
- 315 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
ADHD
A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.
- Trial name
- NCT07314333
- Testing
- Centanafadine, Methylphenidate, Lisdexamfetamine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.