Clinical trials: sponsored by Biogen
Major Depressive Disorder, Insomnia
A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
This study is a randomized, double-blind, placebo-controlled study of the safety, tolerability, and efficacy of SAGE-217 compared to placebo in adult participants with comorbid major depressive disorder (MDD) and insomnia.
- Trial name
- NCT03771664
- Testing
- SAGE-217
- Where
- 28 sites in United States
- Volunteers
- 87 people
- Sponsor
- Biogen
Major Depressive Disorder
A Study to Evaluate the Efficacy of SAGE-217 in the Treatment of Adult Participants With Major Depressive Disorder
This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants with major depressive disorder (MDD).
- Trial name
- NCT03672175
- Testing
- SAGE-217
- Where
- 53 sites in United States
- Volunteers
- 581 people
- Sponsor
- Biogen
Parkinson Disease
A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease
This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease.
- Trial name
- NCT03000569
- Testing
- SAGE-217, Levodopa, Antiparkinsonian Agent(s)
- Where
- 11 sites in United States
- Volunteers
- 29 people
- Sponsor
- Biogen
Major Depressive Disorder
A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB), placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in adults with major depressive disorder (MDD).
- Trial name
- NCT04007367
- Testing
- SAGE-217
- Where
- 46 sites in United States
- Volunteers
- 53 people
- Sponsor
- Biogen
Essential Tremor
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
- Trial name
- NCT02978781
- Testing
- SAGE-217
- Where
- 26 sites in United States
- Volunteers
- 34 people
- Sponsor
- Biogen
Major Depression
A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder
This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.
- Trial name
- NCT03000530
- Testing
- SAGE-217
- Where
- 8 sites in United States
- Volunteers
- 102 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus, Active Cutaneous Lupus Erythematosus
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement…
- Trial name
- LILAC (NCT02847598)
- Testing
- BIIB059 (litifilimab)
- Where
- 128 sites in United States, Argentina and 10 more
- Volunteers
- 264 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis (RRMS)
Plegridy Satisfaction Study in Participants
The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with injectable subcutaneous Interferons, as…
- Trial name
- PLATINUM (NCT02587065)
- Testing
- peginterferon beta-1a
- Where
- 30 sites in Italy
- Volunteers
- 193 people
- Sponsor
- Biogen
Amyotrophic Lateral Sclerosis
An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)
The primary objectives of Parts A and B of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of tofersen in adults with ALS and a documented superoxide dismutase 1 (SOD1) mutation.
- Trial name
- VALOR (Part C) (NCT02623699)
- Testing
- Tofersen
- Where
- 40 sites in United States, Australia and 10 more
- Volunteers
- 176 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS.
- Trial name
- NCT03870763
- Testing
- Dimethyl Fumarate, Peginterferon Beta-1a
- Where
- 23 sites in United States, Colombia and 11 more
- Volunteers
- 11 people
- Sponsor
- Biogen
Cognitive Impairment Associated With Schizophrenia
A Study to Evaluate the Safety and Efficacy of BIIB104 in Participants With Cognitive Impairment Associated With Schizophrenia (CIAS)
The primary objective of the study is to evaluate the efficacy of BIIB104 in participants with CIAS, using the Working Memory Domain of the MATRICS Consensus Cognitive Battery (MCCB).
- Trial name
- TALLY (NCT03745820)
- Testing
- BIIB104
- Where
- 60 sites in United States, Germany and 3 more
- Volunteers
- 195 people
- Sponsor
- Biogen
Alzheimer's Disease
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD.
- Trial name
- TANGO (NCT03352557)
- Testing
- BIIB092
- Where
- 101 sites in United States, Australia and 7 more
- Volunteers
- 654 people
- Sponsor
- Biogen
Multiple Sclerosis
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS).
- Trial name
- NCT02634307
- Testing
- ALKS 8700
- Where
- 115 sites in United States, Belgium and 8 more
- Volunteers
- 1,057 people
- Sponsor
- Biogen
Multiple Sclerosis
Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)
The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks.
- Trial name
- AFFINITY (NCT03222973)
- Testing
- BIIB033 (opicinumab)
- Where
- 159 sites in United States, Australia and 13 more
- Volunteers
- 263 people
- Sponsor
- Biogen
Parkinson's Disease
Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's Disease
The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score.
- Trial name
- SPARK (NCT03318523)
- Testing
- BIIB054
- Where
- 75 sites in United States, Austria and 7 more
- Volunteers
- 357 people
- Sponsor
- Biogen
Epilepsy, Focal Seizures, Partial Seizures
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
The primary efficacy objective of the study is to determine if adjunctive therapy of natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult participants with drug-resistant focal epilepsy.
- Trial name
- OPUS (NCT03283371)
- Testing
- Natalizumab
- Where
- 31 sites in United States
- Volunteers
- 67 people
- Sponsor
- Biogen
Schizophrenia
Multiple Ascending Doses of PF-04958242 in Subjects With Stable Schizophrenia
This study aims to assess the safety, tolerability and pharmacokinetics of PF-04958242 in multiple ascending doses in subjects with stable schizophrenia.
- Trial name
- MAD (NCT02332798)
- Testing
- PF-04958242
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Biogen
Cognitive Dysfunction, Alzheimer's Disease
A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities
The primary objective of the study is to assess the safety impact of continuing aducanumab dosing in asymptomatic Amyloid-related Imaging Abnormalities (ARIA) in participants with mild cognitive impairment (MCI) due to…
- Trial name
- EVOLVE (NCT03639987)
- Testing
- Aducanumab
- Where
- 22 sites in United States
- Volunteers
- 52 people
- Sponsor
- Biogen
Alzheimer's Disease
221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as…
- Trial name
- EMERGE (NCT02484547)
- Testing
- Aducanumab (BIIB037)
- Where
- 180 sites in United States, Belgium and 11 more
- Volunteers
- 1,643 people
- Sponsor
- Biogen
Alzheimer's Disease
221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as…
- Trial name
- ENGAGE (NCT02477800)
- Testing
- Aducanumab (BIIB037)
- Where
- 181 sites in United States, Australia and 12 more
- Volunteers
- 1,653 people
- Sponsor
- Biogen