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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.
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
Awards & highlights
REASON Trial Summary
This trial is testing a new drug, BIIB094, to see if it's safe and effective for treating Parkinson's disease.
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.Check my eligibility
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.See study design
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.
REASON Trial 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?
REASON Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary outcome measures
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BIIB094
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast) of BIIB094
Maximum Concentration (Cmax) of BIIB094
+3 moreREASON 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).
Find a Location
Who is running the clinical trial?
BiogenLead Sponsor
639 Previous Clinical Trials
467,315 Total Patients Enrolled
Ionis Pharmaceuticals, Inc.Industry Sponsor
146 Previous Clinical Trials
15,201 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,403 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does my medical profile fit the criteria of this experiment?
"This clinical trial is looking to recruit 82 persons between 35 and 80 years of age diagnosed with Parkinson's disease (PD) within the last 7 years. In addition, patients must be at a Modified Hoehn and Yahr Stage ≤ 3, have an ability to comprehend the study purpose and risks as well as consenting for their confidential health information use according to regulations."
Answered by AI
Has the FDA sanctioned BIIB094 for therapeutic use?
"Limited clinical data regarding BIIB094's safety and efficacy suggests it should be ranked a 1 on our scale."
Answered by AI
How many locations are engaged in the execution of this experiment?
"Currently, 10 medical centres in cities including Cleveland, Philadelphia and Knoxville are enrolling patients. It is advised that participants select a site closest to them to limit their travel requirements during the trial."
Answered by AI
How many subjects are being accepted into this experiment?
"This research requires 82 people who meet the eligibility criteria to take part. Prospective participants can join this investigation at Northwestern University PD and Movement Disorders Center in Cleveland, Ohio or The Cleveland Clinic Foundation in Philadelphia, Pennsylvania."
Answered by AI
Are there any vacancies for participants in this clinical research?
"The study is actively seeking participants, with the initial posting on August 12th 2019 and the most recent update occurring on October 31st 2022. This information can be found in the postings of clinicaltrials.gov."
Answered by AI
Does this trial include participants aged 25 or above?
"In order to comply with the entry requirements for this trial, all participants must be between 35 and 80 years old."
Answered by AI
Who else is applying?
How old are they?
18 - 65
65+
What site did they apply to?
Montreal Neurological Institute and Hospital
Research Site
Alliance for Multispecialty Research
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Tennessee
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been on Roprinrole .25mg 3 times a day and Carbidopa-Levodopa 25-100 mg 2 tablets 4 times a day. I recently saw my Neurologist and explained my tremors had gotten worse and that I was experience a lot of movement with my mouth. He stated it was due to a new medication that my Pyschiatrist had put me on Seroquel 100 mg 2 tablets at bedtime. I was taken off that medication 30 days ago but continue to experience the shakes and mouth movement so I called his nurse and advise that I am now taking Trazadone 150 mg for sleep and she advised he did not want any change s made.
PatientReceived 2+ prior treatments
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