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Inland Northwest Research | Spokane, WA

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

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Biogen

Status and phase

Active, not recruiting
Phase 1

Conditions

Parkinson's Disease

Treatments

Drug: Placebo
Drug: BIIB094

Study type

Interventional

Funder types

Industry

Identifiers

NCT03976349
254PD101
2018-002995-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

35 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

81 participants in 13 patient groups, including a placebo group

Part A (SAD): BIIB094 Dose 1
Experimental group
Description:
Participants will receive a single IT injection of BIIB094 during Part A [Single Ascending Dose (SAD)].
Treatment:
Drug: BIIB094
Part A (SAD): BIIB094 Dose 2
Experimental group
Description:
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Treatment:
Drug: BIIB094
Part A (SAD): BIIB094 Dose 3
Experimental group
Description:
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Treatment:
Drug: BIIB094
Part A (SAD): BIIB094 Dose 4
Experimental group
Description:
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Treatment:
Drug: BIIB094
Part A (SAD): BIIB094 Dose 5
Experimental group
Description:
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Treatment:
Drug: BIIB094
Part A (SAD): BIIB094 Dose 6
Experimental group
Description:
Participants will receive a single IT injection of BIIB094 during Part A (SAD).
Treatment:
Drug: BIIB094
Part B (MAD): BIIB094 Dose 1
Experimental group
Description:
Participants will receive a single IT injection of BIIB094 on multiple days during Part B [Multiple Ascending Dose (MAD)].
Treatment:
Drug: BIIB094
Part B (MAD): BIIB094 (Non LRRK2) Dose 2
Experimental group
Description:
Participants [Non leucine-rich repeat kinase 2 (Non LRRK2)] will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
Treatment:
Drug: BIIB094
Part B (MAD): BIIB094 (LRRK2) Dose 2
Experimental group
Description:
Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
Treatment:
Drug: BIIB094
Part B (MAD): BIIB094 (Non LRRK2) Dose 3
Experimental group
Description:
Participants (Non LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
Treatment:
Drug: BIIB094
Part B (MAD): BIIB094 (LRRK2) Dose 3
Experimental group
Description:
Participants (LRRK2) will receive a single IT injection of BIIB094 on multiple days during Part B (MAD).
Treatment:
Drug: BIIB094
Part A (SAD): Matching Placebo
Placebo Comparator group
Description:
Participants will receive matching placebo during Part A [Single Ascending Dose (SAD)].
Treatment:
Drug: Placebo
Part B (MAD): Matching Placebo
Placebo Comparator group
Description:
Participants will receive matching placebo on multiple days during Part B (MAD).
Treatment:
Drug: Placebo

Trial contacts and locations

16

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Central trial contact

Global Biogen Clinical Trial Center; US Biogen Clinical Trial Center

Data sourced from clinicaltrials.gov

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