NSAA NON-Interventional Study Protocol | NCT06054971

Studies
NSAA NON-Interventional Study Protocol

NCT06054971

Sponsor

Red Nucleus Enterprise Solutions, LLC

Status

Completed

Last Update Posted

Mar 21, 2025Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Duchenne Muscular Dystrophy

Interventions

Remote Administration of NSAA

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2023Actual

Primary Completion Date

Feb 3, 2025Actual

Completion Date

Mar 13, 2025Actual

First Submitted Date

Sep 12, 2023

First Submission Date that Met QC Criteria

Sep 19, 2023

First Posted Date

Sep 26, 2023Actual

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

Mar 18, 2025

Last Update Posted Date

Mar 21, 2025Actual

Name	Class
Pfizer	INDUSTRY

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD). The iTakeControl (iTC) software platform will be utilized to remotely administer and score the NSAAs.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Group A will have Live telemedicine assessments completed prior to caregiver Asynchronous Video	Other: Remote Administration of NSAA
Group B		Group B will have Caregiver Asynchronous Video first, followed by live telemedicine	Other: Remote Administration of NSAA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remote Administration of NSAA	Other	Remote Administration of NSAA	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores		6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent.
Confirmed diagnosis of DMD
Participant with DMD aged 4 to12 (inclusive) at t Enrollment date
Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study
Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application
Participant and caregiver are based in the US throughout study
Participant and caregiver are fluent in the English language (verbally and in writing)

Exclusion Criteria:

Non-ambulatory DMD participant at any study timepoint
Caregiver/participant unwilling or unable to administer/perform the NSAA
Anticipated deterioration of participant's ambulatory status during the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Individuals with confirmed diagnosis of DMD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Red Nucleus Solutions		Malvern	Pennsylvania	19355	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

Condition Browse Module

MeSH Terms

ID	Term
D020388	Muscular Dystrophy, Duchenne

Ancestor Terms

ID	Term
D009136	Muscular Dystrophies
D020966	Muscular Disorders, Atrophic
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided