Clinical trials: sponsored by Biogen
Spinal Muscular Atrophy
An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy
This study will test the safety, tolerability, and pharmacokinetics of escalating doses of nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over the duration of the trial, in participants with…
- Trial name
- NCT01703988
- Testing
- Nusinersen
- Where
- 4 sites in United States
- Volunteers
- 34 people
- Sponsor
- Biogen
Spinal Muscular Atrophy
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)
The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA).
- Trial name
- NCT01839656
- Testing
- nusinersen
- Where
- 4 sites in United States, Canada
- Volunteers
- 21 people
- Sponsor
- Biogen
Spinal Muscular Atrophy
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)
The primary objective of this study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally to participants with later-onset Spinal Muscular Atrophy (SMA).
- Trial name
- CHERISH (NCT02292537)
- Testing
- Nusinersen
- Where
- 24 sites in United States, Canada and 8 more
- Volunteers
- 126 people
- Sponsor
- Biogen
Healthy Adult Subjects, Healthy Elderly Subjects
Multiple Dose Study Of BIIB118 (PF-05251749) In Healthy Volunteers
This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118
- Trial name
- NCT02691702
- Testing
- BIIB118, Melatonin
- Where
- 2 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Biogen
Spinal Muscular Atrophy
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy
The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA).
- Trial name
- ENDEAR (NCT02193074)
- Testing
- nusinersen
- Where
- 31 sites in United States, Australia and 11 more
- Volunteers
- 122 people
- Sponsor
- Biogen
Spinal Muscular Atrophy
A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).
The primary objective of Part 1 of this study is to assess the safety and tolerability of Nusinersen in participants with SMA who are not eligible to participate in the clinical studies ISIS 396443-CS3B (NCT02193074) or ISIS…
- Trial name
- EMBRACE (NCT02462759)
- Testing
- Nusinersen
- Where
- 7 sites in United States, Germany
- Volunteers
- 21 people
- Sponsor
- Biogen
Healthy
Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)
This is a First in human (FIH) single ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy human subjects
- Trial name
- NCT02443740
- Testing
- BIIB118
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and…
- Trial name
- ENDORSE (NCT00835770)
- Testing
- dimethyl fumarate
- Where
- 246 sites in United States, Australia and 32 more
- Volunteers
- 1,736 people
- Sponsor
- Biogen
Supranuclear Palsy, Progressive
Study of BIIB092 in Participants With Progressive Supranuclear Palsy
The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of…
- Trial name
- PASSPORT (NCT03068468)
- Testing
- BIIB092
- Where
- 86 sites in United States, Australia and 11 more
- Volunteers
- 490 people
- Sponsor
- Biogen
Idiopathic Pulmonary Fibrosis
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF).
- Trial name
- SPIRIT (NCT03573505)
- Testing
- BG00011
- Where
- 90 sites in United States, Argentina and 15 more
- Volunteers
- 109 people
- Sponsor
- Biogen
Relapsing Remitting Multiple Sclerosis
A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability…
- Trial name
- NCT03093324
- Testing
- ALKS 8700, Dimethyl Fumarate
- Where
- 67 sites in United States, Germany and 1 more
- Volunteers
- 506 people
- Sponsor
- Biogen
Multiple Sclerosis
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl…
- Trial name
- MITIGATE (NCT02410278)
- Testing
- dimethyl fumarate, montelukast
- Where
- 50 sites in United States
- Volunteers
- 102 people
- Sponsor
- Biogen
Idiopathic Pulmonary Fibrosis (IPF)
STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
The primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized monoclonal antibody directed against the alpha v beta 6 (αvβ6)…
- Trial name
- NCT01371305
- Testing
- BG00011
- Where
- 10 sites in United States
- Volunteers
- 41 people
- Sponsor
- Biogen
Cognitive Impairment Associated With Schizophrenia (CIAS)
A Study To Evaluate The Safety And Efficacy Of PF-04958242 In Subjects With Cognitive Impairment Associated With Schizophrenia (CIAS)
The purpose of this study is to determine whether PF-04958242 is safe and effective in the treatment of cognitive dysfunction in schizophrenia subjects
- Trial name
- NCT02855411
- Testing
- PF-04958242
- Where
- 16 sites in United States
- Volunteers
- 35 people
- Sponsor
- Biogen
Healthy
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of PF-04958242 in Healthy Subjects
The purpose of the current study is to characterize the pharmacokinetic (PK) profile of PF 04958242 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor.
- Trial name
- NCT02341482
- Testing
- PF-04958242, Itraconazole
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers
- Trial name
- NCT02228395
- Testing
- PF-04958242
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis…
- Trial name
- EXTEND (NCT01797965)
- Testing
- BIIB019 (Daclizumab)
- Where
- 222 sites in United States, Argentina and 25 more
- Volunteers
- 1,501 people
- Sponsor
- Biogen
Multiple Sclerosis, Relapsing-Remitting
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200).
- Trial name
- NCT02555215
- Testing
- dimethyl fumarate
- Where
- 12 sites in United States, Belgium and 8 more
- Volunteers
- 20 people
- Sponsor
- Biogen
Relapsing-Remitting Multiple Sclerosis (RRMS)
Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab
The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched…
- Trial name
- SUSTAIN (NCT02881567)
- Testing
- Daclizumab
- Where
- 11 sites in United States, Canada and 3 more
- Volunteers
- 41 people
- Sponsor
- Biogen
Acute Optic Neuritis
Long-Term Assessment of Remyelinating Therapy
The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit.
- Trial name
- RENEWED (NCT02657915)
- Testing
- BIIB033 100mg/Kg
- Where
- 23 sites in Australia, Belgium and 9 more
- Volunteers
- 52 people
- Sponsor
- Biogen