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NCT03976349 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease

A Phase 1 study of Parkinson's Disease, sponsored by Ionis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target
18
Study locations

NCT03976349 is a Phase 1 study of Parkinson's Disease that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 62 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (90% lower). The trial reports 18 study locations across 12 states.

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The verdict

NCT03976349, a Phase 1 study of Parkinson's Disease, has completed, sponsored by Ionis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target
18
Study locations

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson's Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic variant.

Conditions Studied

Parkinson's Disease

Interventions

  • DRUG Placebo
  • DRUG BIIB094

Study Locations (18)

Other

  • Sourasky Medical Center - Tel Aviv
  • Neuro-SysMed Center - Bergen
  • St. Olav University Hospital - Trondheim
  • Hospital Clinic de Barcelona - Barcelona
  • Hospital General Universitario Gregorio Marañón - Madrid
  • Research Site - Seville
  • Queen Square (Neurology) CRF Site Institute of Neurology & the National Hospital for Neurology and Neurosurgery UCLH - London

Illinois

  • Northwestern University PD and Movement Disorders Center - Chicago

Michigan

  • Quest Research Institute - Farmington Hills

Ohio

  • The Cleveland Clinic Foundation - Cleveland

Oregon

  • Oregon Health and Science University - Portland

Pennsylvania

  • University of Pennsylvania - Philadelphia

Tennessee

  • Alliance for Multispecialty Research - Knoxville

Washington

  • Inland Northwest Research - Spokane

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2019-08-12
Est. Completion 2024-08-12
Phase Phase 1

Sponsor

Ionis Pharmaceuticals

76 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03976349

The ClinicalTrials.gov registry entry for NCT03976349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (90% lower). The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03976349 reports 18 study locations spanning 12 distinct geographic areas - top geographies include Other, Illinois, Michigan.

Frequently Asked Questions

What is clinical trial NCT03976349 about?

NCT03976349 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's Disease". The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson's Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of B...

What is the current status of trial NCT03976349?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2019-08-12. Estimated completion is 2024-08-12.

What conditions does trial NCT03976349 study?

This clinical trial studies the following conditions: Parkinson's Disease.

What interventions are being tested in trial NCT03976349?

The interventions under investigation include: Placebo (DRUG), BIIB094 (DRUG).

Who is sponsoring clinical trial NCT03976349?

This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03976349 being conducted?

This trial has 18 study locations across Illinois, Michigan, Ohio, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.