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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04106050
Other study ID # 255NP101
Secondary ID 2019-001900-39
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date September 30, 2020
Est. completion date January 21, 2022

Study information

Verified date March 2021
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 excitability in diabetic polyneuropathy (DPN) and assessing the safety, tolerability and pharmacokinetics of BIIB095. Part B (optional): Equivalent objectives are pursued for BIIB074.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 21, 2022
Est. primary completion date January 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria: - 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 Criteria: - 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Compound Muscle Action Potential Threshold Tracking (CMAP-TT) in the Median Nerve of Healthy Participants Baseline (Day 1), Day 8
Secondary Change in Sensory Nerve Excitability from Baseline (Day 1) to Last Treatment Visit (Day 8) as Determined by Sensory Nerve Action Potential Threshold Tracking (SNAP-TT) in the Median Nerve of Healthy Participants Baseline (Day 1), Day 8
Secondary Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs: Day 1 up to Day 22; SAEs: Screening up to Day 22
Secondary Area Under the Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Secondary Area Under the Curve within a Dosing Interval (AUCtau) Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Secondary Maximum Observed Concentration (Cmax) Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Secondary Trough Concentration (Ctrough) Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
Secondary Time to Reach Maximum Observed Concentration (Tmax) Pre-dose, 1 hour (h), 1.5h, 3h, 6h and 8h post-dose on Day 8
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