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Pharmacodynamic Study of BIIB095 and BIIB074 in Healthy Participants and Participants With Painful Diabetic Polyneuropathy

NCT04106050 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-03-22

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Diabetic Neuropathies

Interventions

DRUG

BIIB095

Administered as specified in the treatment arm.

DRUG

BIIB074

Administered as specified in the treatment arm.

DRUG

Placebo

Administered as specified in the treatment arm.

DRUG

Lidocaine

Administered as specified in the treatment arm.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2022-01-21
Completion
2022-01-21

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Entities

Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04106050 on ClinicalTrials.gov