Study synopses

Study synopses

Lundbeck provides open access to clinical trial result summaries (synopses) from Lundbeck-sponsored phase II-IV trials completed after January 1, 2014, following market authorization in US or EU.  

Product (compound)

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Aripiprazole once-monthly versus paliperidone palmitate in adult patients with schizophrenia   2015   A 28-week, randomised, open-label study evaluating the effectiveness of aripiprazole once-monthly versus paliperidone palmitate in adult patients with schizophrenia   14724A  

NCT01795547

2012-002785-12
Aripiprazole once-monthly in patients with schizophrenia   2015   Interventional, open-label, flexible-dose extension study of aripiprazole once-monthly in patients with schizophrenia   14724B  

NCT01959035

2012-003239-47

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Rasagiline in cognitive-impairment related depression: Azilect in cognitive-impairment related depression (ACCORDO)   2014   A randomised, double-blind, placebo-controlled study to evaluate if rasagiline can improve depressive symptoms and cognitive function in non-demented, idiopathic Parkinson's disease patients. ACCORDO Study (Azilect® in cognitive-impairment related depression)   12962A  

NCT01055379

2009-011144-19
Rasagiline in early Parkinson's disease patients not treated with levodopa in China   2014   Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of rasagiline in early Parkinson's disease patients not treated with levodopa in China   13485A  

NCT01556165

EudraCT N/A

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Vortioxetine in Patients With Depression and Early Dementia (MEMORY)   2022   Interventional, open-label study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder and early dementia   18315A  

NCT04294654

2019-001326-10
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   2022   Long-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 18 years of age   12712A   NCT02871297
2008-005356-25
Vortioxetine to Prevent Return of Symptoms in Children With Depression   2022   A double-blind, randomized, placebo-controlled, multicentre, relapse-prevention study of vortioxetine in paediatric patients aged 7 to 11 years with Major Depressive Disorder   13546A   NCT05014919
2010-020493-42
Open-label, Flexible-dose Study of Vortioxetine in Patients With Depression in India   2022   Open-label, flexible-dose study of vortioxetine in patients with Major Depressive Disorder in India   17775A   NCT04288895
EudraCT N/A
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)   2022   Interventional, randomized, double-blind, placebocontrolled, active-reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 7 to 11 years, with Major Depressive Disorder (MDD)   12709A   NCT02709655
2008-005353-38
Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression (VIVRE)   2022   A randomized, double-blind, parallel-group, active-controlled study evaluating the efficacy of vortioxetine versus desvenlafaxine in adult patients suffering from major depressive disorder with partial response to SSRI treatment   18498A   NCT04448431
2019-002704-41
Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD) (RECONNECT)   2021   Interventional, open-label effectiveness study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder comorbid with generalized anxiety disorder   18314A  

NCT04220996

2019-001325-27
Study with vortioxetine on emotional functioning in patients with depression (COMPLETE)   2021   Interventional, open-label, flexible-dose study of vortioxetine on emotional symptoms in patients with major depressive disorder with inadequate response to SSRI/SNRI treatment   17797A  

NCT03835715

2017-004829-33
Continuation with vortioxetine in child and adolescent patients with major depressive disorder (MDD) from 7 to 17 years of age   2020   Long-term, open-label, flexible-dose, continuation extension study with vortioxetine in child and adolescent patients with major depressive disorder (MDD) from 7 to 17 years of age   12712B  

NCT03108625

2015-002658-11
Vortioxetine intravenous infusion at initiation of oral treatment with vortioxetine in patients with depression   2020   Interventional, randomised, double-blind, placebo-controlled study of the efficacy and safety of initial administration of 25 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with major depressive disorder   17915A  

NCT03766867

2018-000992-34
Active reference (fluoxetine) fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years with major depressive disorder (MDD)   2019   Interventional, randomised, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 12 to 17 years, with major depressive disorder (MDD)   12710A  

NCT02709746

2008-005356-25
Assessment in Work Productivity and the Relationship With Cognitive Symptoms in Patients With MDD Taking Vortioxetine (AtWoRC)   2018   Interventional, open-label, single cohort, Canadian study to describe the relationship between cognitive symptoms and work productivity in working adults treated with vortioxetine for Major Depressive Disorder   15913A  

NCT02332954

EudraCT N/A
Investigating the Effect of Vortioxetine in Adult ADHD Patients   2017   Interventional, randomised, double-blind, placebo-controlled, fixed-dose study of vortioxetine in adults with Attention Deficit Hyperactivity Disorder (ADHD)   15996A  

NCT02327013

EudraCT N/A
Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder   2017   Interventional, randomised, double-blind, parallel-group study of the efficacy and safety of initial administration of 17 mg vortioxetine intravenously with 10 mg/day vortioxetine orally in patients with Major Depressive Disorder   16903A  

NCT02919501

2015-005081-30
Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder   2016   An interventional, randomised, double-blind, parallel-group, placebo-controlled study on the efficacy of vortioxetine on cognitive dysfunction in patients with partial or full remission of major depressive disorder   15905A  

NCT02279953

2014-000229-19
Efficacy of Vortioxetine on Cognitive Dysfunction in Working Patients With Major Depressive Disorder   2016   An interventional, randomised, double-blind, parallel-group, placebo-controlled, active-referenced (paroxetine), fixed-dose study on the efficacy of vortioxetine on cognitive dysfunction in working patients with major depressive disorder   15906A  

NCT02279966

2014-000230-34
Efficacy of Vortioxetine Versus Escitalopram on Cognitive Function in Patients With Inadequate Response to Current Antidepressant Treatment of Major Depressive Disorder   2016   An interventional, randomised, double-blind, parallel-group, active-comparator, flexible-dose study on the efficacy of vortioxetine versus escitalopram on cognitive dysfunction in patients with inadequate response to current antidepressant treatment of major depressive disorder   15907A  

NCT02272517

2014-000231-16
Pharmacokinetics and Tolerability of Vortioxetine (Lu AA21004) in Child and Adolescent Patients With Depressive or Anxiety Disorder   2015   An open-label study evaluating the pharmacokinetics and tolerability of Lu AA21004 in connection with multiple oral dosing of Lu AA21004 in child and adolescent patients with DSM-IV-TRTM diagnosis of depression or anxiety disorder   12708A  

NCT01491035

2010-020170-42
Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries   2014   A randomised, double-blind, parallel-group, active-comparator (venlafaxine extended release), fixed-dose study of Lu AA21004 in Major Depressive Disorder in Asian countries   13926A  

NCT01571453

EudraCT N/A

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Comparison of Once Daily and Twice Daily Dosing on Safety and Tolerability of Memantine in Patients With Alzheimer   2016   Interventional, randomised, double-blind, study to evaluate the safety and tolerability of once daily versus twice daily memantine treatment in patients with dementia of Alzheimer's type and MMSE range 5-18   14603A  

NCT02553928

EudraCT N/A

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension (RESTORE)   2023   RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess sustained effecTs of dRoxidopa thErapy   16306A  

NCT02586623

EudraCT N/A
A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy   2015   A clinical study of patients with symptomatic neurogenic orthostatic hypotension to assess sustained effects of droxidopa therapy   16305A  

NCT01927055

EudraCT N/A

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome   2016   A multi-site, prospective, open-label, long-term, flexible dose, interventional study to evaluate the safety and tolerability of clobazam as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome   14362B  

NCT02187809

EudraCT N/A

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment   2016   Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose long-term study to evaluate the maintenance of efficacy and safety of 1 to 3 mg/day of brexpiprazole as adjunctive treatment in patients with major depressive disorder with an inadequate response to antidepressant treatment   14570A  

NCT01838681

2012-004169-42
Brexpiprazole in Patients With Schizophrenia   2016   Interventional, open-label, flexible-dose extension study of brexpiprazole in patients with schizophrenia   14644B  

NCT01810783

2012-002705-21
Long-term Safety and Tolerability Study of Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder   2016   Interventional, open-label, long-term extension study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in patients with major depressive disorder.   14767B  

NCT01944969

2012-004169-42
Brexpiprazole as an Adjunctive Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)   2016   Interventional, randomised, double-blind, parallel-group, placebo-controlled, flexible-dose study of brexpiprazole as adjunctive treatment to paroxetine or sertraline in adult patients suffering from post-traumatic stress disorder (PTSD)   14865A  

NCT01987960

2012-004982-41
Evaluation of the Safety of Adjunct Brexpiprazole in Elderly Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Treatment   2016   Interventional, open-label, flexible-dose, long-term study to evaluate the safety and tolerability of brexpiprazole as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to  antidepressant treatment   16160A  

NCT02400346

2014-003547-35
Brexpiprazole in Patients With Acute Schizophrenia   2015   Interventional, randomised, double-blind, parallel-group, placebo-controlled, active-reference, flexible-dose study of brexpiprazole in patients with acute schizophrenia   14644A  

NCT01810380

2012-002252-17
Study of Brexpiprazole as Adjunctive Treatment of Sleep Disturbances in Patients With Major Depressive Disorder   2015   Interventional, open-label, flexible-dose, exploratory study of brexpiprazole as adjunctive treatment of sleep disturbances in patients with major depressive disorder   15352A  

NCT01942733

EudraCT N/A
Study of Brexpiprazole as Adjunctive Treatment of Irritability in Patients With Major Depressive Disorder and an Inadequate Response to Antidepressant Therapy   2015   Interventional, open-label, flexible-dose, exploratory study of brexpiprazole as adjunctive treatment of irritability in patients with major depressive disorder and an inadequate response to antidepressant therapy   15353A  

NCT01942785

EudraCT N/A
Efficacy and Safety of Brexpiprazole as Adjunctive Treatment in Elderly Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment   2014   Interventional, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of brexpiprazole (1 and 3 mg/day) as adjunctive treatment in elderly patients with major depressive disorder with an inadequate response to antidepressant treatment   14571A  

NCT01837797

2012-001361-32

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)   2015   A prospective, open-label study of the structure and function of the retina in adult patients with refractory complex partial seizures treated with vigabatrin (Sabril®)   13098A  

NCT01278173

EudraCT N/A

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use   2016   Exploratory, interventional, open-label, fixed dose study with Selincro® as-needed use, in alcohol dependent patients with liver impairment   15871A  

NCT02197598

2014-000413-31
Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care   2016   Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of
patients with alcohol dependence in primary care		   15892A  

NCT02195817

2013-004688-30

Brief title       Year
       Official study title       Lundbeck study identifier       Other identifier(s): ClinicalTrials.gov, EudraCT/EU CT
Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine (SUNRISE)   2025   Interventional, randomized, double-blind, parallel-group, placebo-controlled trial to evaluate efficacy and safety of eptinezumab for the preventive treatment of migraine   19140A   NCT04921384
2020-001657-42
2023-510183-12-00
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan   2025   Interventional, open-label, flexible-dose, long-term extension trial to evaluate safety of eptinezumab as preventive treatment in participants with migraine in Japan   19140B   NCT05064371
EudraCT/EU CT N/A
A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache (RESOLUTION)   2025   Interventional, randomized, double-blind, parallel-group, placebo-controlled study of add-on eptinezumab treatment to brief educational intervention for the preventive treatment of migraine in patients with dual diagnosis of migraine and medication overuse headache   20007A   NCT05452239
2021-003049-40
2024-510729-24-00
Real World Effectiveness of Eptinezumab in Participants With Migraine (EVEC)   2023   An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States   19766N  

NCT05284019

EudraCT N/A
Eptinezumab in Adults With Migraine and Medication Overuse Headache (Sunlight)   2023   Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of eptinezumab for the preventive treatment of migraine in patients with a dual diagnosis of migraine and medication overuse headache   19139A  

NCT04772742

2020-001669-35
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments (DELIVER)   2023   Interventional, randomized, double-blind, parallel-group, placebo-controlled study with an extension period to evaluate the efficacy and safety of eptinezumab for the prevention of migraine in patients with unsuccessful prior preventive treatments   18898A  

NCT04418765

2019-004497-25
A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine (RELIEF)   2021   A parallel-group, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of eptinezumab administered intravenously in patients experiencing an acute attack of migraine   18903A  

NCT04152083

EudraCT N/A
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine (PREVAIL)   2019   An open label phase 3 trial to evaluate the safety of ALD403 administered intravenously in patients with chronic migraine   19022A  

NCT02985398

EudraCT N/A
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine (PROMISE 1)   2018   A Parallel Group Double-Blind Randomized Placebo Controlled Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Frequent Episodic Migraines   19016A  

NCT02559895

EudraCT N/A
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine (PROMISE 2)   2018   A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients with Chronic Migraine   19020A  

NCT02974153

2016-001306-41
A Multicenter Assessment of ALD403 in Chronic Migraine   2017   A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients with Chronic Migraine   19015A  

NCT02275117

EudraCT N/A