Personalized Antisense Oligonucleotide Therapy for A Single Participant With TARDBP ALS

NCT ID: NCT07095712

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2025-11-30

Brief Summary

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This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in TARDBP.

Detailed Description

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This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in TARDBP

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label

Group Type EXPERIMENTAL

nL-TARD-001

Intervention Type DRUG

Personalized antisense oligonucleotide

Interventions

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nL-TARD-001

Personalized antisense oligonucleotide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s)
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records
* Genetically confirmed neurological disorder

Exclusion Criteria

* Participant has any condition that in the opinion of the Site Investigator would ultimately prevent the completion of study procedures
* Use of an investigational medication within less than 5 half-lives of the drug at enrollment
Minimum Eligible Age

49 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

n-Lorem Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Columbia University, Irving Medical Center

New York, New York, United States

Site Status

Houston Methodist

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PRO00038978

Identifier Type: -

Identifier Source: org_study_id

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