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New Parkinson's drug BIIB094 passes first safety test in small trial

NCT ID NCT03976349

Disease control Sponsor: Ionis Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tested the safety of a new drug called BIIB094 in 62 adults with Parkinson's disease. The drug was given as a spinal injection to see if it is safe and how the body processes it. The study included people with and without certain genetic variations. Results will help decide if further testing is warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BIIB094
What this could lead to
If successful, this could point toward a new treatment option for Parkinson's disease by targeting a genetic pathway.
What could go wrong
This is a very early Phase 1 trial focused on safety, not effectiveness. It is small (62 people) and may not lead to a working treatment. Side effects from the spinal injection are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

62 people

The number who actually took part.

Started

Aug 2019

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. * Diagnosed with PD within 7 years at the time of initial enrollment (i.e., at time of SAD enrollment for rollover participants), without major motor fluctuations or dyskinesia that may interfere with study treatment and assessments in the opinion of the investigator after consultation with the Sponsor. * Modified Hoehn and Yahr Stage ≤ 3. Key Exclusion Criteria: * Montreal Cognitive Assessment (MoCA) score less than (\<) 23, dementia, or other significant cognitive impairment that, in the opinion of the Investigator, would interfere with study evaluation. * History of any brain surgery for PD or a history of focused ultrasound treatment at any time; or history of neuromodulation procedures. * Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year before Screening. * History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities within 1 year before Screening. * Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within 3 months before dosing (Day 1) or glycosylated hemoglobin value greater than or equal to (≥) 8 percent (%) at Screening. * History or positive test result at Screening for human immunodeficiency virus. * History or positive test result at Screening for hepatitis C virus antibody. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease

Contacts and locations

Locations

  • Alliance for Multispecialty Research

    Knoxville, Tennessee, 37920, United States

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital General de Catalunya

    Barcelona, Vizcaya, 08195, Spain

  • Inland Northwest Research

    Spokane, Washington, 99202, United States

  • Laboratorios de Investigación Biocruces 3., Hospital de Cruces

    Barakaldo, Bizkaia, 48903, Spain

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, QC H3A 2B4, Canada

  • Neuro-SysMed Center

    Bergen, 5053, Norway

  • Northwestern University PD and Movement Disorders Center

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Queen Square (Neurology) CRF Site Institute of Neurology & the National Hospital for Neurology and Neurosurgery UCLH

    London, WC1N 3BG, United Kingdom

  • Quest Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Research Site

    Toronto, Ontario, Canada

  • Research Site

    Seville, Spain

  • Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • St. Olav University Hospital

    Trondheim, 7030, Norway

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19107, United States

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