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
Abilify Maintena® (aripiprazole) 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

Abilify Maintena® (aripiprazole) 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

Azilect®
(rasagiline)
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

Azilect®
(rasagiline)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Brintellix®
(vortioxetine)
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

Ebixa®
(memantine)
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

Northera®
(droxidopa)
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

Onfi®
(clobazam)
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

Rexulti®
(brexpiprazole)
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

Rexulti®
(brexpiprazole)
Brexpiprazole in Patients With Schizophrenia 2016 Interventional, open-label, flexible-dose extension study of brexpiprazole in patients with schizophrenia 14644B

NCT01810783

2012-002705-21

Rexulti®
(brexpiprazole)
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

Rexulti®
(brexpiprazole)
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

Rexulti®
(brexpiprazole)
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

Rexulti®
(brexpiprazole)
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

Rexulti®
(brexpiprazole)
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

Rexulti®
(brexpiprazole)
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

Rexulti®
(brexpiprazole)
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

Sabril®
(vigabatrin)
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

Selincro®
(nalmefene)
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

Selincro®
(nalmefene)
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

Vyepti®
(eptinezumab)
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

Vyepti®
(eptinezumab)
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

Vyepti®
(eptinezumab)
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

Vyepti®
(eptinezumab)
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

Vyepti®
(eptinezumab)
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