Clinical trials: sponsored by H. Lundbeck A/S
Chronic Migraine in Children
A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
- Trial name
- PROSPECT-2 (NCT04965675)
- Testing
- Eptinezumab
- Where
- 79 sites in United States, Argentina and 9 more
- Volunteers
- 285 people
- Sponsor
- H. Lundbeck A/S
Episodic Migraine
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
- Trial name
- PROSPECT-1 (NCT05897320)
- Testing
- Eptinezumab
- Where
- 60 sites in United States, Argentina and 9 more
- Volunteers
- 315 people
- Sponsor
- H. Lundbeck A/S
Migraine
A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine
The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.
- Trial name
- REJOIN (NCT05164172)
- Testing
- Eptinezumab
- Where
- 64 sites in United States, Argentina and 9 more
- Volunteers
- 600 people
- Sponsor
- H. Lundbeck A/S
Schizophrenia
Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.
- Trial name
- NCT02411695
- Testing
- Brexpiprazole (OPC-34712)
- Where
- 10 sites in United States
- Volunteers
- 43 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia
- Trial name
- NCT03238326
- Testing
- Brexpiprazole
- Where
- 57 sites in United States, France and 8 more
- Volunteers
- 295 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Irritability Associated With Autism Spectrum Disorder (ASD)
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder
The purpose of this study is to find out about the potential benefits and safety of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
- Trial name
- NCT04174365
- Testing
- Brexpiprazole
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Irritability Associated With Autism Spectrum Disorder
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148
The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent participants, aged 5 to 17, with irritability associated with autism spectrum disorder.
- Trial name
- NCT04258839
- Testing
- Brexpiprazole
- Where
- 28 sites in United States
- Volunteers
- 95 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia
To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.
- Trial name
- NCT03198078
- Testing
- Brexpiprazole (OPC-34712), Aripiprazole
- Where
- United States
- Volunteers
- 316 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Migraine in Children, Migraine
A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
- Trial name
- NCT04537429
- Testing
- Eptinezumab
- Where
- 9 sites in United States
- Volunteers
- 28 people
- Sponsor
- H. Lundbeck A/S
Depression
Vortioxetine to Prevent Return of Symptoms in Children With Depression
The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
- Trial name
- NCT05014919
- Testing
- Vortioxetine
- Where
- 17 sites in United States, Colombia and 5 more
- Volunteers
- 35 people
- Sponsor
- H. Lundbeck A/S
Depressive Disorder, Major
Long-term, Open-label, Flexible-dose, Extension Study of Vortioxetine in Child and Adolescent Participants With Major Depressive Disorder (MDD) From 7 to 18 Years of Age
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD.
- Trial name
- NCT02871297
- Testing
- Vortioxetine
- Where
- 78 sites in United States, Bulgaria and 18 more
- Volunteers
- 662 people
- Sponsor
- H. Lundbeck A/S
Depressive Disorder, Major
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
- Trial name
- NCT02709655
- Testing
- Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20mg/day
- Where
- 98 sites in United States, Bulgaria and 17 more
- Volunteers
- 683 people
- Sponsor
- H. Lundbeck A/S
Depressive Disorder, Major
Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD
- Trial name
- NCT03108625
- Testing
- Vortioxetine
- Where
- 31 sites in Bulgaria, Estonia and 11 more
- Volunteers
- 94 people
- Sponsor
- H. Lundbeck A/S
Depressive Disorder, Major
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition)…
- Trial name
- NCT02709746
- Testing
- Vortioxetine 10 mg/day, Vortioxetine 20 mg/day, Fluoxetine 20 mg/day
- Where
- 124 sites in United States, Bulgaria and 17 more
- Volunteers
- 784 people
- Sponsor
- H. Lundbeck A/S
ADHD, Autism
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders.
- Conditions
- ADHD, Autism, Bipolar I Disorder, Conduct Disorder
- Trial name
- NCT03292848
- Testing
- Brexpiprazole
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Agitation Associated With Alzheimer's Disease, Alzheimer's Type
Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo
To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.
- Conditions
- Agitation Associated With Alzheimer's Disease, Alzheimer's Type, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02192554
- Where
- 84 sites in United States, Bulgaria and 10 more
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Dravet Syndrome
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
- Trial name
- NCT02187809
- Testing
- Clobazam
- Where
- 9 sites in United States, Mexico
- Volunteers
- 3 people
- Sponsor
- H. Lundbeck A/S
Depressive Disorder, Anxiety Disorder
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder
The objective of the study is to evaluate the pharmacokinetics of vortioxetine and its metabolites in connection with multiple oral dosing in child and adolescent patients with a DSM-IV-TR diagnosis of Depressive or Anxiety…
- Trial name
- NCT01491035
- Testing
- Vortioxetine
- Where
- 7 sites in United States, Germany
- Volunteers
- 48 people
- Sponsor
- H. Lundbeck A/S
Patent Ductus Arteriosus, Prematurity
Early Versus Late Use of Ibuprofen for Patent Ductus Arteriosus (PDA) Closure
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of…
- Trial name
- NCT00833365
- Testing
- Ibuprofen
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Utah
Parkinson's Disease
ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects
Eligible participants, who participated in the ADAGIO trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations.
- Trial name
- NCT00936676
- Testing
- rasagiline mesylate
- Where
- 102 sites in United States, Argentina and 11 more
- Volunteers
- 684 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.