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Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074

NCT02957617 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2019-02-25

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).

Conditions

  • Neuropathic Pain From Lumbosacral Radiculopathy

Interventions

DRUG

BIIB074

Participants will receive an initial dose regimen of 350mg orally twice daily (BID), which may be reduced to 200mg based on tolerability for up to 12 months.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2019-02-07
Completion
2019-02-07

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Georgia
  • Italy
  • Latvia
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02957617 on ClinicalTrials.gov