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Clinical Trials

Scientists at the medical school are conducting hundreds of clinical trials daily. Browse our list of actively recruiting clinical trials below to learn more and find out how you may be able to participate. 

For more information about the research or participation, please call our office at 312-695-6829. Learn more about all the medical school's trials via the Feinberg Office of Research Clinical Trials page. You can also visit the Clinical Trials & Studies page on the Les Turner ALS Foundation website for information.

Trials
Radicava® (Edaravone) Biomarker Study in Participants with Amyotrophic Lateral Sclerosis
REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and p…
REFINE-ALS is a prospective, observational, longitudinal, multicenter study designed to identify biomarkers to serve as quantifiable biological non-clinical measures of Edaravone effects in ALS. Epigenetic and protein biomarkers will also be investigated.

Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

Ajroud-Driss, SendaAjroud-Driss, Senda
NCT04259255 STU00210057
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Natural history study of ALS and other motor neuron disorders

Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

Ajroud-Driss, SendaAjroud-Driss, Senda
STU00209860
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Oxidative Markers and Efficacy in ALS/MND Phenotypes Treated with Edaravone

We are only recruiting patients who have not started their edaravone treatment.

Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

Inclusion:

Either possible, probable, or definite ALS,predominantly lower motor neuron disease Predominantly upper motor neuron disease, orbulbar

With or without cognitive involvement

Willing to participate

On no experimental treatment

Ages 18 - 85

No prior exposure to Radicava

On a stable dose of riluzole for 30 days or offriluzole

Male or female

Females of childbearing age must usecontraception

Exclusion:

Unstable medical illness

Abnormal liver function (>2x ULN)

Unlikely to survive for at least 26 weeks

Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
NCT04097158 STU00211350
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Platform Trial for the Treatment of Amyotrophic Lateral Sclerosis (ALS): A perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

In this trial, multiple investigational products for ALS will be tested simul…

In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.

The additional details that govern the testing of each investigational product will be summarized in separate regimen-specific appendices (RSAs). Each regimen will have a separate ClinicalTrials.gov posting, which will include specific information about the regimen. All regimen-specific outcome measures will be detailed in each regimen posting.

Participants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized in a 3:1 ratio to either study drug or placebo.

The following regimens are active in the trial:

Regimen A - Zilucoplan Regimen B - Verdiperstat Regimen C - CNM-Au8

New regimens will be continuously added as new investigational products become available. The HEALEY ALS Platform Trial will enroll additional participants as each new regimen is available.

Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

Ajroud-Driss, SendaAjroud-Driss, Senda
NCT04297683 STU00212680
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ALS Platform
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A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects with Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation
This is a randomized, double-blind, placebo-controlled, 3-part dose escalation stud…
This is a randomized, double-blind, placebo-controlled, 3-part dose escalation study to examine the efficacy, safety, tolerability of BIIB067, administered by intrathecal bolus injection to up to approximately 183 adult subjects with ALS and confirmed SOD1 mutation.Northwestern is only participating in Part C of this study.The primary objective of Part C of this study is to evaluate the clinical efficacy of BIIB067 administered to adult subjects with ALS, who are fast-progressing, and confirmed SOD1 mutation.

Location of study: Les Turner ALS Center at Northwestern Medicine, 259 E. Erie St., Lavin 19, Chicago, IL 60611.

Ajroud-Driss, SendaAjroud-Driss, Senda
  • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
    Chicago, IL
NCT02623699 STU00211658
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ALS SOD1
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A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS)
This is a phase 3, placebo-controlled, study comparing the safety and efficacy of two doses of MASITINIB (4.5 mg and 6.0 mg) and riluzole vs. placebo and riluzole over 48 weeks. 
Basic Inclusion/ Exclusion criteria:

  • Patient treated with stable dose of riluzole for 3 months
  • Patient able to obtain riluzole through insurance and remain on riluzole throughout the study
  • Disease duration (weakness) from diagnosis less than 24 months
  • Must have a sub-score of at least 2 on every sub-section of the ALSFRS-R
  • FVC over 60%
  • Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT02588677 STU00213943
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    A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)
    This is a phase 3b, randomized, study evaluating the safety and efficacy of ORAL EDARAVONE/ RADICAVA adm…
    This is a phase 3b, randomized, study evaluating the safety and efficacy of ORAL EDARAVONE/ RADICAVA administered over 48 weeks. Eligible participants are randomized to two groups with different dosing schemes.
    Basic Inclusion/ Exclusion criteria:

  • No prior use of radicava/edaravone
  • ALS weakness onset within the last 2 years
  • FVC over 70%
  • Must score at least a 2 on each sub-section of the ALSFRS-R
  • El Escorial scored Probable or Definite ALS
  • Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04165824 STU00213716
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    A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety of Engensis in Participants with Amyotrophic Lateral Sclerosis
    This is a phase 2, placebo-controlled, study assessing the safety of ENGENSIS. Participants will be randomized to study drug (66%) or placebo…
    This is a phase 2, placebo-controlled, study assessing the safety of ENGENSIS. Participants will be randomized to study drug (66%) or placebo (34%). This study drug or placebo is administered via intramuscular injections. 128 injections are administered in different parts of the body on one treatment day. There are 6 treatment days when the study drug or placebo is administered. The study lasts approximately 6 months.
    Basic Inclusion/ Exclusion criteria:

  • Onset of ALS weakness within the last 4 years
  • SVC over 50%
  • Stable dose of riluzole for 1 month, or not start during study
  • Stable dose of radicava for 1 month, or not start during study
  • Limb onset of ALS required
  • No personal history of cancer within the last 3 years
  • Ajroud-Driss, SendaAjroud-Driss, Senda
    • Map it Lavin Pavillion 259 E. Erie St., Suite 19-100
      Chicago, IL
    NCT04632225 STU00214139
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    ALS Engensis
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