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
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
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
Dravet Syndrome
Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16…
- Trial name
- NCT02174094
- Testing
- Clobazam
- Where
- 9 sites in United States, Mexico
- Sponsor
- H. Lundbeck A/S