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