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Monoclonal Antibodies
BIIB094 for Parkinson's Disease (REASON Trial)
Phase 1
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Modified Hoehn and Yahr Stage ≤ 3
Modified Hoehn and Yahr Stage ≤ 3.
Must not have
History of any brain surgery for PD or a history of focused ultrasound treatment at any time; or history of neuromodulation procedures
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: screening (day -42) up to day 85, part b: screening (day -77) up to day 253
Summary
This trial tests the safety and behavior of a drug called BIIB094 in patients with Parkinson's Disease, including those with different genetic backgrounds.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, common ones from intrathecal injections may include headache, back pain, nausea and potential risk of infection at the injection site. Side effects from BIIB094 will be closely monitored given its experimental nature.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Parkinson's disease is at an early or mid-stage.
Select...
My Parkinson's disease is at an early or mid-stage.
Select...
It seems like the criterion is incomplete. Could you please provide more information or context so that I can assist you accurately?
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have never had brain surgery or focused ultrasound for Parkinson's disease, nor any neuromodulation procedures.
Select...
My diabetes is not well-controlled, with recent medication changes or HbA1c ≥ 8%.
Select...
I have not had a stroke, mini-stroke, or unexplained fainting in the last year.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part a: screening (day -42) up to day 85, part b: screening (day -77) up to day 253
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: screening (day -42) up to day 85, part b: screening (day -77) up to day 253
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Trial Design
13Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B (MAD): BIIB094 Dose 1Experimental Treatment1 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 3Experimental Treatment1 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 2Experimental Treatment1 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 3Experimental Treatment1 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 2Experimental Treatment1 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 6Experimental Treatment1 Intervention
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Group VII: Part A (SAD): BIIB094 Dose 5Experimental Treatment1 Intervention
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Group VIII: Part A (SAD): BIIB094 Dose 4Experimental Treatment1 Intervention
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Group IX: Part A (SAD): BIIB094 Dose 3Experimental Treatment1 Intervention
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Group X: Part A (SAD): BIIB094 Dose 2Experimental Treatment1 Intervention
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Group XI: Part A (SAD): BIIB094 Dose 1Experimental Treatment1 Intervention
Participants will receive a single IT injection of BIIB094 during Part A \[Single Ascending Dose (SAD)\].
Group XII: Part A (SAD): Matching PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo during Part A \[Single Ascending Dose (SAD)\].
Group XIII: Part B (MAD): Matching PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo on multiple days during Part B (MAD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIIB094
2019
Completed Phase 1
~90
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Parkinson's Disease (PD) primarily aim to manage motor symptoms by addressing dopamine deficiency in the brain. Levodopa, often combined with carbidopa, is the most effective treatment, converting to dopamine in the brain to replenish low levels.
Dopamine agonists (e.g., pramipexole, ropinirole) mimic dopamine's effects, while MAO-B inhibitors (e.g., selegiline, rasagiline) prevent dopamine breakdown. COMT inhibitors (e.g., entacapone) extend the effect of levodopa by inhibiting its metabolism.
Treatments like BIIB094, a potential LRRK2 inhibitor, target genetic mutations linked to PD, aiming to modify disease progression by reducing abnormal protein activity. These mechanisms are crucial as they not only alleviate symptoms but also hold potential for slowing disease progression, improving quality of life for PD patients.
Therapies for Genetic Forms of Parkinson's Disease: Systematic Literature Review.Polypharmacy in Parkinson's disease: risks and benefits with little evidence.New pharmacological options for treating advanced Parkinson's disease.
Therapies for Genetic Forms of Parkinson's Disease: Systematic Literature Review.Polypharmacy in Parkinson's disease: risks and benefits with little evidence.New pharmacological options for treating advanced Parkinson's disease.
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
646 Previous Clinical Trials
467,431 Total Patients Enrolled
Ionis Pharmaceuticals, Inc.Industry Sponsor
150 Previous Clinical Trials
27,447 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,892 Previous Clinical Trials
8,089,240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of hepatitis C or tested positive for hepatitis C virus.My Parkinson's disease is at an early or mid-stage.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.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.My Parkinson's disease is at an early or mid-stage.Your Montreal Cognitive Assessment (MoCA) score is less than 23, or you have dementia or other serious problems with thinking that could affect the study.You have had a positive test for HIV.My diabetes is not well-controlled, with recent medication changes or HbA1c ≥ 8%.It seems like the criterion is incomplete. Could you please provide more information or context so that I can assist you accurately?I have not had a stroke, mini-stroke, or unexplained fainting in the last year.I was diagnosed with Parkinson's disease within the last 7 years and do not have severe movement issues.
Research Study Groups:
This trial has the following groups:- Group 1: Part A (SAD): BIIB094 Dose 4
- Group 2: Part A (SAD): BIIB094 Dose 5
- Group 3: Part B (MAD): BIIB094 Dose 1
- Group 4: Part B (MAD): BIIB094 (Non LRRK2) Dose 2
- Group 5: Part B (MAD): BIIB094 (LRRK2) Dose 2
- Group 6: Part A (SAD): BIIB094 Dose 2
- Group 7: Part B (MAD): BIIB094 (Non LRRK2) Dose 3
- Group 8: Part B (MAD): BIIB094 (LRRK2) Dose 3
- Group 9: Part A (SAD): Matching Placebo
- Group 10: Part B (MAD): Matching Placebo
- Group 11: Part A (SAD): BIIB094 Dose 1
- Group 12: Part A (SAD): BIIB094 Dose 3
- Group 13: Part A (SAD): BIIB094 Dose 6
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT03976349 — Phase 1
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