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A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation (ATLAS)

Primary Purpose

Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tofersen
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Part A Inclusion Criteria:

  • Participants should have a protocol-defined rapidly progressive SOD1 mutation, confirmed by a central reader, or a SOD1 mutation that is approved for inclusion by an external mutation adjudication committee.
  • Participants with plasma NfL level less than the protocol-defined threshold.
  • Participants who are clinically presymptomatic for ALS (i.e., must not have clinically manifest ALS).

Key Part A Exclusion Criteria:

  • History or positive test result at screening for human immunodeficiency virus (HIV). The requirement for testing at Screening may be omitted if it is not permitted by local regulations.
  • Current hepatitis C infection (defined as positive Hepatitis C Virus (HCV) antibody and detectable HCV RNA). Participants with positive HCV antibody and undetectable HCV Ribonucleic Acid (RNA) are eligible to participate in the study (United States Centers for Disease Control and Prevention).
  • Current hepatitis B infection (defined as positive for hepatitis B surface antigen (HBsAg) and/or anti-Hepatitis B Core antibody (HBc)). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-hepatitis B surface antibody (HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti- HBs) are eligible to participate in the study.
  • History of systemic hypersensitivity reaction to tofersen, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study.
  • History of confounding neuromuscular or neurological disorder that is expected to have a progressive (i.e., worsening) course during the study, and/or is expected to be associated with elevations in NF, in the opinion of the Investigator.
  • Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that if not managed optimally could place a participant at an increased risk for intraoperative or postoperative bleeding.
  • Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression

    ≤ 90 days of screening, which in the opinion of the Investigator would interfere with the study procedures.

  • Treatment with riluzole and/or edaravone. If the participant has been on riluzole and/or edaravone, the medication(s) must be discontinued for at least 5 half-lives prior to screening.
  • Use of off-label treatments for ALS.
  • Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs), biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Specifically, no prior treatment with small interfering RNA, stem cell therapy, or gene therapy is allowed.
  • Anticipated need, in the opinion of the Investigator, for administration of any antiplatelet or anticoagulant medication (e.g., clopidogrel) that cannot be safely continued or held for an LP procedure, if necessary, according to local or institutional guidelines and/or Investigator determination.
  • Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment, biological agent, device, or approved therapy for investigational use. Participation in a noninterventional study focused on ALS natural history may be allowed at the discretion of the Investigator.

NOTE: Other protocol defined Inclusion/Exclusion criteria will apply.

Sites / Locations

  • HonorHealth NeurologyRecruiting
  • UC San DiegoRecruiting
  • California Pacific Medical CenterRecruiting
  • Holy Cross Hospital Phil Smith Neuroscience InstituteRecruiting
  • University of MiamiRecruiting
  • Emory UniversityRecruiting
  • Northwestern UniversityRecruiting
  • Johns Hopkins HospitalRecruiting
  • Massachusetts General HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • Columbia University Medical CenterRecruiting
  • Austin Neuromuscular CenterRecruiting
  • Macquarie UniversityRecruiting
  • UZ LeuvenRecruiting
  • Hospital Sao PauloRecruiting
  • University of CalgaryRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • Genge Partners Inc.Recruiting
  • Hôpital Pitié-SalpêtrièreRecruiting
  • Universitaetsklinikum UlmRecruiting
  • Hannover Medical SchoolRecruiting
  • Cresla "Rita Levi Montalcini" Department of NeuroscienceRecruiting
  • Kagoshima University HospitalRecruiting
  • University of Tokyo HospitalRecruiting
  • Hanyang University Seoul HospitalRecruiting
  • Centrum Medyczne Neuro ProtectRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • University Hospital of UmeaRecruiting
  • SheffieldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Part A: Natural History Run-in

Part B: Randomized, Double-Blind, Placebo-Controlled

Part C: Open-Label Extension

Part D: Open-Label Treatment

Arm Description

Participants enrolled in Part A will undergo blood draws approximately once every 28 days to assess neurofilament light chain (NfL) levels.

Participants from Part A who meet the protocol-defined NfL threshold and remain presymptomatic may be eligible to participate in Part B. During Part B, participants will receive tofersen 100 milligram (mg) or placebo via intrathecal (IT) injection on Days 1, 15, 29, and every 28 days thereafter for up to 2 years.

Participants from Part B who develop clinically manifest ALS may be eligible to participate in Part C. During Part C, participants who received placebo in Part B will receive tofersen 100 mg via IT injection on Days 1, 15, 29, and every 28 days thereafter for up to 2 years. Participants who received tofersen during Part B will receive tofersen 100 mg on Days 1, 29, and every 28 days thereafter for up to 2 years, with a dose of placebo on Day 15 to maintain the study blind.

Participants from Part A who develop clinically manifest ALS prior to randomization in Part B may be eligible to participate in Part D. During Part D, participants will receive tofersen100 mg via IT injection on Days 1, 15, 29, and every 28 days thereafter for up to 2 years.

Outcomes

Primary Outcome Measures

Parts B and C: Percentage of Participants with Emergence of Clinically Manifest ALS Within 12 Months of Part B Baseline

Secondary Outcome Measures

Parts B and C: Percentage of Participants with Emergence of Clinically Manifest ALS Within 24 Months of Part B Baseline
Parts B and C: Time to Emergence of Clinically Manifest ALS
Parts B and C: Change in ALS Functional Rating Scale (ALSFRS-R) Total Score
The ALSFRS-R measures 4 functional domains: respiratory, bulbar function, gross motor skills, and fine motor skills. There are 12 questions, each scored from 0 to 4, for a total possible score of 48, with higher scores representing better function.
Parts B and C: Change from Baseline in Percent Predicted Slow Vital Capacity (SVC)
Parts B and C: Percentage of Participants with Outcome as Death or Permanent Ventilation Based on Time to Death or Permanent Ventilation Analysis
Permanent ventilation is defined as ≥22 hours of invasive or non-invasive mechanical ventilation per day for ≥21 consecutive days.
Parts B and C: Percentage of Participants with Outcome as Deaths Based on Time to Death Analysis
Parts B, C and D: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) during the Treatment Period
Parts B, C and D: Change from Baseline in Plasma NfL Concentrations
Parts B, C and D: Change in Total Cerebrospinal Fluid (CSF) SOD1 Concentrations

Full Information

First Posted
April 20, 2021
Last Updated
July 14, 2023
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT04856982
Brief Title
A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation
Acronym
ATLAS
Official Title
A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
August 7, 2027 (Anticipated)
Study Completion Date
August 7, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the efficacy of tofersen in presymptomatic adult carriers of a superoxide dismutase 1 (SOD1) mutation with elevated neurofilament (NF). The secondary objectives of this study are to evaluate the safety and tolerability tofersen and to evaluate the effect of tofersen on pharmacodynamics (PD)/treatment response biomarkers when initiated prior to versus at the time of emergence of clinically manifest amyotrophic lateral sclerosis (ALS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: Natural History Run-in
Arm Type
No Intervention
Arm Description
Participants enrolled in Part A will undergo blood draws approximately once every 28 days to assess neurofilament light chain (NfL) levels.
Arm Title
Part B: Randomized, Double-Blind, Placebo-Controlled
Arm Type
Experimental
Arm Description
Participants from Part A who meet the protocol-defined NfL threshold and remain presymptomatic may be eligible to participate in Part B. During Part B, participants will receive tofersen 100 milligram (mg) or placebo via intrathecal (IT) injection on Days 1, 15, 29, and every 28 days thereafter for up to 2 years.
Arm Title
Part C: Open-Label Extension
Arm Type
Experimental
Arm Description
Participants from Part B who develop clinically manifest ALS may be eligible to participate in Part C. During Part C, participants who received placebo in Part B will receive tofersen 100 mg via IT injection on Days 1, 15, 29, and every 28 days thereafter for up to 2 years. Participants who received tofersen during Part B will receive tofersen 100 mg on Days 1, 29, and every 28 days thereafter for up to 2 years, with a dose of placebo on Day 15 to maintain the study blind.
Arm Title
Part D: Open-Label Treatment
Arm Type
Experimental
Arm Description
Participants from Part A who develop clinically manifest ALS prior to randomization in Part B may be eligible to participate in Part D. During Part D, participants will receive tofersen100 mg via IT injection on Days 1, 15, 29, and every 28 days thereafter for up to 2 years.
Intervention Type
Drug
Intervention Name(s)
Tofersen
Other Intervention Name(s)
BIIB067, QALSODY
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Parts B and C: Percentage of Participants with Emergence of Clinically Manifest ALS Within 12 Months of Part B Baseline
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Parts B and C: Percentage of Participants with Emergence of Clinically Manifest ALS Within 24 Months of Part B Baseline
Time Frame
Up to 24 months
Title
Parts B and C: Time to Emergence of Clinically Manifest ALS
Time Frame
Up to 2 years
Title
Parts B and C: Change in ALS Functional Rating Scale (ALSFRS-R) Total Score
Description
The ALSFRS-R measures 4 functional domains: respiratory, bulbar function, gross motor skills, and fine motor skills. There are 12 questions, each scored from 0 to 4, for a total possible score of 48, with higher scores representing better function.
Time Frame
Up to 2 years
Title
Parts B and C: Change from Baseline in Percent Predicted Slow Vital Capacity (SVC)
Time Frame
Up to 2 years
Title
Parts B and C: Percentage of Participants with Outcome as Death or Permanent Ventilation Based on Time to Death or Permanent Ventilation Analysis
Description
Permanent ventilation is defined as ≥22 hours of invasive or non-invasive mechanical ventilation per day for ≥21 consecutive days.
Time Frame
Up to 2 years
Title
Parts B and C: Percentage of Participants with Outcome as Deaths Based on Time to Death Analysis
Time Frame
Up to 2 years
Title
Parts B, C and D: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) during the Treatment Period
Time Frame
Up to 2 years
Title
Parts B, C and D: Change from Baseline in Plasma NfL Concentrations
Time Frame
Up to 2 years
Title
Parts B, C and D: Change in Total Cerebrospinal Fluid (CSF) SOD1 Concentrations
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Part A Inclusion Criteria: Participants should have a protocol-defined rapidly progressive SOD1 mutation, confirmed by a central reader, or a SOD1 mutation that is approved for inclusion by an external mutation adjudication committee. Participants with plasma NfL level less than the protocol-defined threshold. Participants who are clinically presymptomatic for ALS (i.e., must not have clinically manifest ALS). Key Part A Exclusion Criteria: History or positive test result at screening for human immunodeficiency virus (HIV). The requirement for testing at Screening may be omitted if it is not permitted by local regulations. Current hepatitis C infection (defined as positive Hepatitis C Virus (HCV) antibody and detectable HCV RNA). Participants with positive HCV antibody and undetectable HCV Ribonucleic Acid (RNA) are eligible to participate in the study (United States Centers for Disease Control and Prevention). Current hepatitis B infection (defined as positive for hepatitis B surface antigen (HBsAg) and/or anti-Hepatitis B Core antibody (HBc)). Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-hepatitis B surface antibody (HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti- HBs) are eligible to participate in the study. History of systemic hypersensitivity reaction to tofersen, the excipients contained in the formulation, and if appropriate, any diagnostic agents to be administered during the study. History of confounding neuromuscular or neurological disorder that is expected to have a progressive (i.e., worsening) course during the study, and/or is expected to be associated with elevations in NF, in the opinion of the Investigator. Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that if not managed optimally could place a participant at an increased risk for intraoperative or postoperative bleeding. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, suicidal ideation, suicide attempt, or untreated major depression ≤ 90 days of screening, which in the opinion of the Investigator would interfere with the study procedures. Treatment with riluzole, edaravone, and/or sodium phenylbutyrate/taurursodiol (also known as ursodoxicoltaurine). If the participant has been on riluzole, edaravone, and/or sodium phenylbutyrate/taurursodiol, the medication(s) must be discontinued for at least 5 half-lives prior to Screening. Use of off-label treatments for ALS. Treatment with another investigational drug (including investigational drugs for ALS through compassionate use programs), biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. Specifically, no prior treatment with small interfering RNA, stem cell therapy, or gene therapy is allowed. Anticipated need, in the opinion of the Investigator, for administration of any antiplatelet or anticoagulant medication (e.g., clopidogrel) that cannot be safely continued or held for an LP procedure, if necessary, according to local or institutional guidelines and/or Investigator determination. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment, biological agent, device, or approved therapy for investigational use. Participation in a noninterventional study focused on ALS natural history may be allowed at the discretion of the Investigator. NOTE: Other protocol defined Inclusion/Exclusion criteria will apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US Biogen Clinical Trial Center
Phone
866-633-4636
Email
clinicaltrials@biogen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Global Biogen Clinical Trial Center
Email
clinicaltrials@biogen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
HonorHealth Neurology
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
6026582863
Email
hri.neuro.levine@gmail.com
First Name & Middle Initial & Last Name & Degree
Todd Dylan Levine
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rose Previte
Email
rprevite@ucsd.edu
First Name & Middle Initial & Last Name & Degree
John Ravits
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Razavi
Phone
415-600-0486
Email
razavirf@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Jonathan Katz
Facility Name
Holy Cross Hospital Phil Smith Neuroscience Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Stepler
Phone
954-542-3442
First Name & Middle Initial & Last Name & Degree
Alameda
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure Grignon
Email
axg1571@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Michael Benatar
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meraida Polak
Phone
404-778-3807
Email
mpolak@emory.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Glass
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
312-503-0671
Email
s-ajroud@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Senda Ajroud-Driss
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
4106149874
Email
nmaragak@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Nicholas John Maragakis
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruitment Coordinator
Phone
617-726-5097
Email
ATLAS@mgb.org
First Name & Middle Initial & Last Name & Degree
Kathleen Diana
Phone
6177246346
Email
kdiana@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Mark Garret
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Robert Bucelli
Phone
844-257-2273
Email
als@wustl.edu
First Name & Middle Initial & Last Name & Degree
Dr Robert Bucelli
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
ML4138@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Andrews
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yessar Hussain
Email
yessar@austinneuromuscle.com
First Name & Middle Initial & Last Name & Degree
Stephanie Gonsoulin
Email
stephanie@austinneuromuscle.com
First Name & Middle Initial & Last Name & Degree
Dr. Yessar Hussain
Facility Name
Macquarie University
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Gan
Phone
+61298123739
Email
richard.gan@mq.edu.au
First Name & Middle Initial & Last Name & Degree
Dominic Rowe
Facility Name
UZ Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
+3216344280
Email
mailto:philip.vandamme@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Dr Philip Van Damme
Facility Name
Hospital Sao Paulo
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04037-002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
Phone
551155764050
Email
pvsgobbi@gmail.com
First Name & Middle Initial & Last Name & Degree
Paulo Victor Sgobbi de Souza
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berchman Wong
Phone
403-210-7009
Email
wongb@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Theodore Mobach, Dr
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4164804475
Email
lorne.zinman@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Lorne H. Zinman
Facility Name
Genge Partners Inc.
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3T2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
5143983868
Email
angela.genge@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Dr. Angela Genge
Facility Name
Hôpital Pitié-Salpêtrière
City
Paris cedex 13
State/Province
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
33142162471
Email
gaelle.bruneteau@upmc.fr
First Name & Middle Initial & Last Name & Degree
Gaelle Bruneteau
Facility Name
Universitaetsklinikum Ulm
City
Ulm
State/Province
Baden Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
497315000
Email
albert.ludolph@rku.de
First Name & Middle Initial & Last Name & Degree
Albert Christian Ludolph
Facility Name
Hannover Medical School
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
Phone
49511532570
Email
petri.susanne@mh-hannover.de
First Name & Middle Initial & Last Name & Degree
Susanne Petri
Facility Name
Cresla "Rita Levi Montalcini" Department of Neuroscience
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Moglia
Phone
+390116335439
Email
cresla.torino@gmail.com
First Name & Middle Initial & Last Name & Degree
Adriano Chio
Facility Name
Kagoshima University Hospital
City
Kagoshima-shi
State/Province
Kagoshima-Ken
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tokyo Hospital
City
Bunkyo-ku
State/Province
Tokyo-To
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
4763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Neuro Protect
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-684
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
Phone
+48501762789
Email
maciej.czarnecki@neuroprotect.pl
First Name & Middle Initial & Last Name & Degree
Maciej Czarnecki
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34644490025
Email
juan.vazquez.neuro@gmail.com
First Name & Middle Initial & Last Name & Degree
Juan Francisco Vazquez Costa
Facility Name
University Hospital of Umea
City
Umeå
State/Province
Västerbotten County
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
Phone
+46907852372
Email
mailto:peter.andersen@umu.se
First Name & Middle Initial & Last Name & Degree
Prof Peter Andersen
Facility Name
Sheffield
City
Sheffield
State/Province
Staffordshire
ZIP/Postal Code
S10 2HQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Email
kathryn.hope3@nhs.net
First Name & Middle Initial & Last Name & Degree
CJ McDermott

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
35585374
Citation
Benatar M, Wuu J, Andersen PM, Bucelli RC, Andrews JA, Otto M, Farahany NA, Harrington EA, Chen W, Mitchell AA, Ferguson T, Chew S, Gedney L, Oakley S, Heo J, Chary S, Fanning L, Graham D, Sun P, Liu Y, Wong J, Fradette S. Design of a Randomized, Placebo-Controlled, Phase 3 Trial of Tofersen Initiated in Clinically Presymptomatic SOD1 Variant Carriers: the ATLAS Study. Neurotherapeutics. 2022 Jul;19(4):1248-1258. doi: 10.1007/s13311-022-01237-4. Epub 2022 May 18. Erratum In: Neurotherapeutics. 2022 Sep 29;:
Results Reference
derived
Links:
URL
http://www.alsATLASstudy.com
Description
Disclaimer: Residents in the United States may click here to find out more about participation in this trial.

Learn more about this trial

A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

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