Clinical Procedures to Support Research in ALS | NCT03489278

ID	Type	Description	Link
U54NS092091	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2018Actual

Primary Completion Date

Jun 2032Estimated

Completion Date

Jun 2034Estimated

First Submitted Date

Mar 23, 2018

First Submission Date that Met QC Criteria

Apr 4, 2018

First Posted Date

Apr 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 15, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Benatar, Chief, Neuromuscular Division, University of MiamiPrincipal Investigator

Lead Sponsor

University of MiamiOTHER

Collaborators

Name	Class
Muscular Dystrophy Association	OTHER
National Institute of Neurological Disorders and Stroke (NINDS)	NIH
National Center for Advancing Translational Sciences (NCATS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders.

Detailed Description

The study will consent patients with ALS or related disorders that are receiving care at a clinical center in the CReATe consortium that uses Epic as its electronic health record (EHR) system. The study aims to systematically gather a clinical dataset through the EHR using a standardized approach to characterize the natural history of ALS and related diseases.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,200Estimated

Label	Type	Description	Intervention Names
Affected		Affected with ALS or a related disorder.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Using the ALS Toolkit for collecting and using electronic health record data for research purposes		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy).
Receiving care at a clinical center that uses Epic as its EHR.
Able and willing to provide informed consent (or informed consent obtainable from a designated proxy).

Exclusion Criteria:

Inability to understand English and/or Spanish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Affected patients receiving care at a clinical center that uses Epic as EHR.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael Benatar, MBChB, MS, DPhil	Contact	1-844-837-1031		projectcreate@miami.edu
Jessica Hernandez	Contact	1-844-837-1031		projectcreate@miami.edu

Overall Officials

Name	Affiliation	Role
Michael Benatar, MBChB, MS, DPhil	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine	Recruiting	Irvine	California	92868	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D000690	Amyotrophic Lateral Sclerosis
D016472	Motor Neuron Disease
D009134	Muscular Atrophy, Spinal

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019636	Neurodegenerative Diseases
D057177	TDP-43 Proteinopathies
D009468	Neuromuscular Diseases
D057165	Proteostasis Deficiencies
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases