Status:
WITHDRAWN
Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteers
Diabetic Neuropathies
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Part A: Primary objective is to determine the effects of BIIB095 on nerve excitability in healthy participants. Secondary and exploratory objectives include determining the effects of BIIB095 on nerve...
Eligibility Criteria
Inclusion
- Key
- Healthy participants must be in good health, as determined based on medical history and screening evaluations
- 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)
- Key
Exclusion
- Any neurologic or painful condition that could confound the interpretation of study results
- 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
- Note: Other protocol-specific inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04106050
Start Date
September 30 2020
End Date
January 21 2022
Last Update
March 22 2021
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