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HEALEY ALS Platform Trial - Master Protocol

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zilucoplan
Verdiperstat
CNM-Au8
Pridopidine
SLS-005 Trehalose
ABBV-CLS-7262
DNL343
Sponsored by
Merit E. Cudkowicz, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS, Placebo-Controlled, Double-Blind, Master Protocol, Lou Gehrig's Disease

Eligibility Criteria

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

Inclusion Criteria:

  1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria.
  2. Age 18 years or older.
  3. Capable of providing informed consent and complying with study procedures, in the SI's opinion.
  4. Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit.
  5. Vital Capacity ≥ 50% of predicted capacity for age, height, and sex at the time of the Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to pandemic-related restrictions, Forced Vital Capacity (FVC).
  6. Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30 days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are permitted in the study.
  7. Participants must either not take edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants are permitted in the study.
  8. Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow for the duration of the study.
  9. Geographically accessible to the site.

Exclusion Criteria:

  1. Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to SI's judgment (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or EKG changes).

    Lab abnormalities include, but are not limited to: Hemoglobin < 10 g/dL, White Blood Cells < 3.0 x 103/mm3, Neutrophils, Absolute ≤ 1000/mm3, Eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), low platelet counts (< 150 x 109 per liter), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN), eGFR < 30 mL/min/1.73m2, thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L.

  2. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion.
  3. Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years.
  4. Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Master Protocol Screening Visit.
  5. Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational).
  6. If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment.
  7. If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment.
  8. Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the SI's opinion.
  9. If a participant is being re-screened, the disqualifying condition has not been resolved, or the mandatory wash-out duration has not occurred.
  10. For those participating in the optional CSF collection, contraindication to undergoing a lumbar puncture (LP) in the SI's opinion. Participants undergoing the LP must not be currently taking anticoagulation medications such as warfarin that would be a contraindication to LP; aspirin and non-steroidal anti-inflammatories are allowed.

Sites / Locations

  • Barrow Neurological InstituteRecruiting
  • Loma Linda University HealthRecruiting
  • University of Southern CaliforniaRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • University of California, IrvineRecruiting
  • Forbes Norris MDA/ALS Research Center, California Pacific Medical CenterRecruiting
  • University of California, San FranciscoRecruiting
  • University of ColoradoRecruiting
  • Hospital for Special CareRecruiting
  • Georgetown UniversityRecruiting
  • George Washington UniversityRecruiting
  • Nova Southeastern UniversityRecruiting
  • Phil Smith Neuroscience Institute at Holy Cross HospitalRecruiting
  • University of FloridaRecruiting
  • Mayo Clinic Florida
  • University of MiamiRecruiting
  • University of South FloridaRecruiting
  • Emory University
  • Augusta UniversityRecruiting
  • Saint Alphonsus Regional Medical CenterRecruiting
  • Northwestern UniversityRecruiting
  • University of ChicagoRecruiting
  • Indiana University Health
  • University of Iowa Hospitals and ClinicsRecruiting
  • University of Kansas Medical CenterRecruiting
  • University of KentuckyRecruiting
  • Ochsner Health System
  • University of MarylandRecruiting
  • Johns Hopkins UniversityRecruiting
  • Massachusetts General HospitalRecruiting
  • Beth Israel Deaconess Medical CenterRecruiting
  • University of Massachusetts Medical SchoolRecruiting
  • University of MichiganRecruiting
  • Henry Ford Health SystemRecruiting
  • Spectrum Health
  • Essentia HealthRecruiting
  • University of Minnesota/Twin Cities ALS Research ConsortiumRecruiting
  • Mayo Clinic - RochesterRecruiting
  • University of Missouri Health Care
  • Saint Louis University
  • Washington University School of MedicineRecruiting
  • Neurology Associates, P.C./Somnos Clinical Research
  • University of Nebraska Medical CenterRecruiting
  • Las Vegas Clinic
  • Dartmouth-Hitchcock Medical CenterRecruiting
  • Columbia University
  • SUNY UpstateRecruiting
  • Duke UniversityRecruiting
  • Wake Forest Health ScienceRecruiting
  • University of CincinnatiRecruiting
  • Cleveland ClinicRecruiting
  • The Ohio State UniversityRecruiting
  • Providence Brain and Spine Institute ALS CenterRecruiting
  • Lehigh Valley Health NetworkRecruiting
  • Penn State HersheyRecruiting
  • Jefferson Weinberg ALS Center, Thomas Jefferson UniversityRecruiting
  • University of PennRecruiting
  • Lewis Katz School of Medicine at Temple UniversityRecruiting
  • University of Pittsburg Medical CenterRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Texas NeurologyRecruiting
  • Houston MethodistRecruiting
  • UTHSCSARecruiting
  • University of UtahRecruiting
  • University of VirginiaRecruiting
  • Swedish Medical CenterRecruiting
  • University of WashingtonRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Regimen A - Zilucoplan

Regimen B - Verdiperstat

Regimen C - CNM-Au8

Regimen D - Pridopidine

Regimen E - SLS-005 Trehalose

Regimen F- ABBV-CLS-7262

Regimen G - DNL343

Arm Description

Participants are randomized to receive either active zilucoplan or matching placebo.

Participants are randomized to receive either active verdiperstat or matching placebo.

Participants are randomized to receive either active CNM-Au8 or matching placebo.

Participants are randomized to receive either active Pridopidine or matching placebo.

Participants are randomized to receive either active SLS-005 Trehalose or matching placebo.

Participants are randomized to receive either active ABBV-CLS-7262 or matching placebo.

Participants are randomized to receive either active DNL343 or matching placebo.

Outcomes

Primary Outcome Measures

Disease Progression
Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.

Secondary Outcome Measures

Respiratory Function
Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Muscle Strength
Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD).
Survival
Comparison of rate of occurrence between groups.

Full Information

First Posted
March 3, 2020
Last Updated
October 2, 2023
Sponsor
Merit E. Cudkowicz, MD
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04297683
Brief Title
HEALEY ALS Platform Trial - Master Protocol
Official Title
HEALEY ALS Platform Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Merit E. Cudkowicz, MD
Collaborators
Massachusetts General Hospital

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 HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
Detailed Description
The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. 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 Regimen D - Priodopidine Regimen E - SLS-005 Trehalose Regimen F - ABBV-CLS-7262 Regimen G - DNL343 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
ALS, Placebo-Controlled, Double-Blind, Master Protocol, Lou Gehrig's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
As new investigational products become available, additional regimens will be added to the HEALEY ALS Platform Trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Regimen A - Zilucoplan
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active zilucoplan or matching placebo.
Arm Title
Regimen B - Verdiperstat
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active verdiperstat or matching placebo.
Arm Title
Regimen C - CNM-Au8
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active CNM-Au8 or matching placebo.
Arm Title
Regimen D - Pridopidine
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active Pridopidine or matching placebo.
Arm Title
Regimen E - SLS-005 Trehalose
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active SLS-005 Trehalose or matching placebo.
Arm Title
Regimen F- ABBV-CLS-7262
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active ABBV-CLS-7262 or matching placebo.
Arm Title
Regimen G - DNL343
Arm Type
Experimental
Arm Description
Participants are randomized to receive either active DNL343 or matching placebo.
Intervention Type
Drug
Intervention Name(s)
Zilucoplan
Intervention Description
Drug: Zilucoplan Administration: Subcutaneous injection Dose: Minimum of .0.22 mg/kg daily to a maximum dose of 0.42 mg/kg daily, dependent on weight
Intervention Type
Drug
Intervention Name(s)
Verdiperstat
Intervention Description
Drug: Verdiperstat Administration: Oral Dose: 600mg twice daily
Intervention Type
Drug
Intervention Name(s)
CNM-Au8
Intervention Description
Drug: CNM-Au8 Administration: Oral Dose: 30 mg or 60 mg daily
Intervention Type
Drug
Intervention Name(s)
Pridopidine
Intervention Description
Drug: Pridopidine Administration: Oral Dose: 45mg twice daily
Intervention Type
Drug
Intervention Name(s)
SLS-005 Trehalose
Intervention Description
Drug: SLS-005 Trehalose Administration: Infusion Dose: 0.75 g/kg weekly
Intervention Type
Drug
Intervention Name(s)
ABBV-CLS-7262
Intervention Description
Drug: ABBV-CLS-7162 Administration: Oral Dose: Dose 1 or Dose 2
Intervention Type
Drug
Intervention Name(s)
DNL343
Intervention Description
Drug: DNL343 Administration: Oral Dose: Once per day
Primary Outcome Measure Information:
Title
Disease Progression
Description
Change in disease severity over time as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R). Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Patients with higher scores have more physical function.
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Respiratory Function
Description
Change in respiratory function over time as measured by Slow Vital Capacity (SVC).
Time Frame
24 Weeks
Title
Muscle Strength
Description
Change in muscle strength over time as measured isometrically using hand-held dynamometry (HHD).
Time Frame
24 Weeks
Title
Survival
Description
Comparison of rate of occurrence between groups.
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria. Age 18 years or older. Capable of providing informed consent and complying with study procedures, in the SI's opinion. Time since onset of weakness due to ALS ≤ 36 months at the time of the Master Protocol Screening Visit. Vital Capacity ≥ 50% of predicted capacity for age, height, and sex at the time of the Master Protocol Screening Visit measured by Slow Vital Capacity (SVC), or, if required due to pandemic-related restrictions, Forced Vital Capacity (FVC). Participants must either not take riluzole or be on a stable dose of riluzole for ≥ 30 days prior to the Master Protocol Screening Visit. Riluzole-naïve participants are permitted in the study. Participants must either not take edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-naïve participants are permitted in the study. Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI's opinion, have the ability to swallow for the duration of the study. Geographically accessible to the site. Participants must either not take Relyvrio/Albrioza or have started Relyvrio/Albrioza ≥ 30 days prior to the Master Protocol Screening Visit Exclusion Criteria: Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant, according to SI's judgment (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, or clinically significant laboratory abnormality or EKG changes). Lab abnormalities include, but are not limited to: Hemoglobin < 10 g/dL, White Blood Cells < 3.0 x 103/mm3, Neutrophils, Absolute ≤ 1000/mm3, Eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter), low platelet counts (< 150 x 109 per liter), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal (ULN), eGFR < 30 mL/min/1.73m2, thyroid-stimulating hormone (TSH) levels >10 mIU/L or <0.01 mIU/L. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the SI's opinion. Active cancer or history of cancer, except for the following: basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years. Use of investigational treatments for ALS (off-label use or active participation in a clinical trial) within 5 half-lives (if known) or 30 days (whichever is longer) prior to the Master Protocol Screening Visit. Exposure at any time to any gene therapies under investigation for the treatment of ALS (off-label use or investigational). If female, breastfeeding, known to be pregnant, planning to become pregnant during the study, or of child-bearing potential and unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment. If male of reproductive capacity, unwilling to use effective contraception for the duration of the trial and for 3 months, or longer as specified in each RSA, after discontinuing study treatment. Anything that would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, in the SI's opinion. If a participant is being re-screened, the disqualifying condition has not been resolved, or the mandatory wash-out duration has not occurred.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HEALEY Center for ALS at Massachusetts General Hospital
Phone
833-425-8257 (HALT ALS)
Email
healeyalsplatform@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merit Cudkowicz, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Whitney Dailey
Email
fulton.research@dignityhealth.org
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Borg
Email
dborg@llu.edu
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salma Akhter
Email
salma.akhter@med.usc.edu
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Mostowy
Email
GroupNeuromuscularResearch@cshs.org
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pola Gaid
Email
polagaid@hs.uci.edu
Facility Name
Forbes Norris MDA/ALS Research Center, California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teji Dulai
Email
teji.dulai@sutterhealth.org
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reshma Kolala
Email
neuromuscular.research@ucsf.edu
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Recruitment Coordinator
Email
NeuroResearch@cuanschutz.edu@cuanschutz.edu
Facility Name
Hospital for Special Care
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Cartwright
Email
ncartwright@hfsc.org
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabby Law
Email
gfl11@georgetown.edu
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Johnsonn
Email
gjohnson@mfa.gwu.edu
Facility Name
Nova Southeastern University
City
Davie
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donovan Mott
Phone
954-262-6387
Email
Donovan.mott@nova.edu
Facility Name
Phil Smith Neuroscience Institute at Holy Cross Hospital
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
Email
ashley.stepler@holy-cross.com
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Steshyn
Email
jennifer.steshyn@neurology.ufl.edu
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Active, not recruiting
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
Jessica Hernandez
Phone
888-413-9315
Email
alsresearch@med.miami.edu
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Shaw
Email
jessshaw@usf.edu
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Completed
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandy Quarles
Phone
706-721-0390
Email
Neuromuscular_research@augusta.edu
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alicia Weeks
Email
neuro.research@saintalphonsus.org
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Schmidt
Email
emma.schmidt@northwestern.edu
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deekshitha Turaka
Email
deekshitha@uchicago.edu
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Anderson
Email
emily-anderson@uiowa.edu
Facility Name
University of Kansas Medical Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katheryn Jennens
Email
kjennens2@kumc.edu
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sura Al Hilfi
Email
sal389@uky.edu
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikram Nambiar
Email
vnambiar@som.umaryland.edu
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Riley
Email
kriley15@jhmi.edu
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
Ludjie Jean Pierre
Phone
617-643-3902
Email
MGHsiteHealeyPlatform@mgh.harvard.edu
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Capella
Email
BIDMCHealeyALSPlatformTrial@bidmc.harvard.edu
Facility Name
University of Massachusetts Medical School
City
North Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Douthwright
Email
ALSresearch@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Reylyn Tanchiatco
Email
ALSresearch@umassmed.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayna Duell
Email
jkballar@med.umich.edu
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beverley Duthie
Email
BDUTHIE1@hfhs.org
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Essentia Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent Gavin
Email
Brent.Gavin@essentiahealth.org
Facility Name
University of Minnesota/Twin Cities ALS Research Consortium
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Ferment
Email
ferm0016@umn.edu
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenda Nelson
Email
Nelson.Brenda6@mayo.edu
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Brown
Email
susan.a.brown@health.slu.edu
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
Rebecca Livigni
Email
als@wustl.edu
Facility Name
Neurology Associates, P.C./Somnos Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katelyn Hilz
Email
katelyn.hilz@unmc.edu
Facility Name
Las Vegas Clinic
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Kersey
Email
gina.e.kersey@hitchcock.org
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
SUNY Upstate
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Deb
Email
debl@upstate.edu
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Ward
Email
ALSResearch@duke.edu
Facility Name
Wake Forest Health Science
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mozhdeh Marandi
Email
mmarandi@wakehealth.edu
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Smith
Email
fisheal@ucmail.uc.edu
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Tainer
Email
tainerm@ccf.org
First Name & Middle Initial & Last Name & Degree
Irys Caristo
Email
caristi@ccf.org
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheyenne Grove
Email
ALSResearch@osumc.edu
Facility Name
Providence Brain and Spine Institute ALS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Adamo
Email
ashley.adamo@providence.org
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Stanley
Email
kevin_a.stanley@lvhn.org
Facility Name
Penn State Hershey
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Runk
Email
hrunk@pennstatehealth.psu.edu
Facility Name
Jefferson Weinberg ALS Center, Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Ahmadi
Email
amir.moghadamahmadi@jefferson.edu
Facility Name
University of Penn
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Burst
Email
Matthew.Burst@pennmedicine.upenn.edu
Facility Name
Lewis Katz School of Medicine at Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Hatala
Email
kathleen.hatala@tuhs.temple.edu
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacquelynn (Jackie) Jones
Email
jonesjr12@upmc.edu
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Davis
Email
diana.davis@vumc.org
Facility Name
Texas Neurology
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Nasri, MD
Email
mnasri@texasneurology.com
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Applegate
Email
rgapplegate@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Patricia Mendoza
Email
pamendoza@houstonmethodist.org
Facility Name
UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randee Kent-Baron
Phone
210-450-0524
Email
kentbaron@uthscsa.edu
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crystal Neate
Email
crystal.neate@hsc.utah.edu
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Wagoner
Email
MIW9B@hscmail.mcc.virginia.edu
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janae Rahiman
Email
janae.rahiman@swedish.org
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassie Chu
Email
kasanac@uw.edu
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Mejaki
Email
mmejaki@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

HEALEY ALS Platform Trial - Master Protocol

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