BIIB094 for Parkinson's Disease

(REASON Trial)

Recruiting at 19 trial locations

Overseen By Global Biogen Clinical Trial Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Disqualifiers: Cognitive impairment, Brain surgery, Stroke, Heart issues, Diabetes, others

Compensation: Varies

Number of Visits: Unknown

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and behavior of a drug called BIIB094 in patients with Parkinson's Disease, including those with different genetic backgrounds.

Do I have to stop taking my current medications for the BIIB094 trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment BIIB094 for Parkinson's Disease?

The research highlights that deep brain stimulation (DBS) of the subthalamic nucleus (STN) is effective in improving motor symptoms in Parkinson's Disease, reducing medication-induced complications, and enhancing daily living activities. While BIIB094 is not directly mentioned, the effectiveness of similar neuromodulation treatments like DBS suggests potential benefits for BIIB094 in managing Parkinson's symptoms. ^{1 2 3 4 5}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

This trial is for adults with Parkinson's Disease diagnosed within the last 7 years, without severe motor issues or dyskinesia. Participants must understand study risks, give informed consent, and have a Modified Hoehn and Yahr Stage ≤ 3. Excluded are those with recent heart problems, uncontrolled diabetes, certain infections like hepatitis C or HIV, recent strokes or loss of consciousness, cognitive impairments (MoCA score <23), or brain surgery history for PD.

Inclusion Criteria

My Parkinson's disease is at an early or mid-stage.

I was diagnosed with Parkinson's disease within the last 7 years and do not have major movement issues.

You are able 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.

Exclusion Criteria

You have a history of hepatitis C or tested positive for hepatitis C virus.

I haven't had serious heart problems or a heart attack in the last year.

I have never had brain surgery or focused ultrasound for Parkinson's disease, nor any neuromodulation procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Treatment Part A (SAD)

Participants receive a single intrathecal injection of BIIB094 or placebo

12 weeks

Treatment Part B (MAD)

Participants receive multiple intrathecal injections of BIIB094 or placebo

25 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BIIB094
• Placebo

Trial Overview The trial tests BIIB094 administered via spinal injection to see if it's safe and tolerable in single/multiple doses compared to a placebo. It also looks at how the body processes this drug. The study includes people with variations in the LRRK2 gene related to PD as well as those without genetic variants.

How Is the Trial Designed?

Group I: Part B (MAD): BIIB094 Dose 1 Experimental Treatment 1 Intervention

Participants will receive a single IT injection of BIIB094 on multiple days during Part B \[Multiple Ascending Dose (MAD)\].

Group II: Part B (MAD): BIIB094 (Non LRRK2) Dose 3 Experimental Treatment 1 Intervention

Participants (Non LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group III: Part B (MAD): BIIB094 (Non LRRK2) Dose 2 Experimental Treatment 1 Intervention

Participants \[Non leucine-rich repeat kinase 2 (Non LRRK2)\] will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group IV: Part B (MAD): BIIB094 (LRRK2) Dose 3 Experimental Treatment 1 Intervention

Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group V: Part B (MAD): BIIB094 (LRRK2) Dose 2 Experimental Treatment 1 Intervention

Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).

Group VI: Part A (SAD): BIIB094 Dose 6 Experimental Treatment 1 Intervention

Participants will receive a single IT injection of BIIB094 during Part A (SAD).

Group VII: Part A (SAD): BIIB094 Dose 5 Experimental Treatment 1 Intervention

Participants will receive a single IT injection of BIIB094 during Part A (SAD).

Group VIII: Part A (SAD): BIIB094 Dose 4 Experimental Treatment 1 Intervention

Participants will receive a single IT injection of BIIB094 during Part A (SAD).

Group IX: Part A (SAD): BIIB094 Dose 3 Experimental Treatment 1 Intervention

Participants will receive a single IT injection of BIIB094 during Part A (SAD).

Group X: Part A (SAD): BIIB094 Dose 2 Experimental Treatment 1 Intervention

Participants will receive a single IT injection of BIIB094 during Part A (SAD).

Group XI: Part A (SAD): BIIB094 Dose 1 Experimental Treatment 1 Intervention

Participants will receive a single IT injection of BIIB094 during Part A \[Single Ascending Dose (SAD)\].

Group XII: Part A (SAD): Matching Placebo Placebo Group 1 Intervention

Participants will receive matching placebo during Part A \[Single Ascending Dose (SAD)\].

Group XIII: Part B (MAD): Matching Placebo Placebo Group 1 Intervention

Participants will receive matching placebo on multiple days during Part B (MAD).

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Ionis Pharmaceuticals, Inc.

Industry Sponsor

Trials

151

Recruited

27,800+

Dr. Brett P. Monia

Ionis Pharmaceuticals, Inc.

Chief Executive Officer since 2020

PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College

Dr. Eric Bastings

Ionis Pharmaceuticals, Inc.

Chief Medical Officer

MD

Published Research Related to This Trial

Current dopamine replacement therapies can alleviate motor symptoms of Parkinson's disease, but there is a significant need for improved treatments that also address non-motor symptoms and provide neuroprotection.

Research is focusing on identifying promising biological targets and therapeutic agents, with an emphasis on understanding genetic factors and enhancing the translation of findings from animal models to human clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Priorities in Parkinson's disease research. Meissner, WG., Frasier, M., Gasser, T., et al.[2022]

In a study of 20 patients with advanced Parkinson's disease, deep brain stimulation (DBS) of the subthalamic nucleus (STN) led to significant improvements in motor symptoms, with a 49.3% reduction in the Unified Parkinson's Disease Rating Scale (UPDRS) scores in the 'off' medication state after one year.

DBS also enhanced daily living activities by 73.8%, reduced the need for medication by 54.1%, and decreased complications like dyskinesia and motor fluctuations, indicating its efficacy in managing Parkinson's disease symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of Advanced Parkinson's Disease Manifestations with Deep Brain Stimulation of the Subthalamic Nucleus: A Single Institution Experience. Rabie, A., Verhagen Metman, L., Fakhry, M., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Bilateral subthalamic stimulation monotherapy in advanced Parkinson's disease: long-term follow-up of patients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Neuromodulation Approaches in Parkinson's Disease Using Deep Brain Stimulation and Transcranial Magnetic Stimulation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Priorities in Parkinson's disease research. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Improvement of Advanced Parkinson's Disease Manifestations with Deep Brain Stimulation of the Subthalamic Nucleus: A Single Institution Experience. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Results of a Randomized Clinical Trial of Speech After Early Neurostimulation in Parkinson's Disease. [2023]