Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
NCT ID: NCT04106050
Last Updated: 2021-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE1
INTERVENTIONAL
2020-09-30
2022-01-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Part B (optional): Equivalent objectives are pursued for BIIB074.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy
NCT03339336
Absorption, Metabolism, and Excretion Study of BIIB074
NCT02751905
A Study to Learn How Safe BAY2395840 is and How Well it Works in Participants Who Have Diabetic Nerve Pain
NCT05219812
A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain
NCT04641273
A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
NCT06203002
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Part A: BIIB095 Dose 1
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 1 capsules from Day 1 to Day 8.
BIIB095
Administered as specified in the treatment arm.
Part A: BIIB095 Dose 2
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 2 capsules from Day 1 to Day 8.
BIIB095
Administered as specified in the treatment arm.
Part A: BIIB095 Dose 3
Healthy participants and participants with DPN will receive oral dose of BIIB095 Dose 3 capsules from Day 1 to Day 8.
BIIB095
Administered as specified in the treatment arm.
Part A: BIIB095 Placebo
Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB095 capsules from Day 1 to Day 8.
Placebo
Administered as specified in the treatment arm.
Part A: Lidocaine
Healthy participants and participants with DPN will receive single injection of lidocaine for partial nerve conduction block and single injection of lidocaine for skin infiltration on Day 8.
Lidocaine
Administered as specified in the treatment arm.
Part B: BIIB074 Dose 1
Healthy participants and participants with DPN will receive oral dose of BIIB074 Dose 1 tablets from Day 1 to Day 8.
BIIB074
Administered as specified in the treatment arm.
Part B: BIIB074 Placebo
Healthy participants and participants with DPN will receive oral dose of placebo matching BIIB074 tablets from Day 1 to Day 8.
Placebo
Administered as specified in the treatment arm.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BIIB095
Administered as specified in the treatment arm.
BIIB074
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Lidocaine
Administered as specified in the treatment arm.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants with DPN
* Must have a documented diagnosis of type 2 diabetes mellitus (DM)
* Must have stable glycemic control
* Must have at least clinical evidence of painful DPN
* Pain related to DPN must be present for at least 6 months prior to screening
* Average daily pain intensity over 7 consecutive days recorded during screening must be ≥ 4 on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)
Exclusion Criteria
* History of any clinically significant cardiac, hematologic, hepatic, immunologic, urologic, pulmonary, dermatologic, psychiatric, renal, or other major disease. This includes any clinically significant endocrinologic or neurologic disease other than DM or DPN.
* Use of local anesthetics or capsaicin for topical or regional treatment within 3 months prior to Screening.
* Systemic use of sodium channel inhibitors
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biogen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Biogen
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-001900-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
255NP101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.