An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 in Subjects WithNeuropathic Pain From Lumbosacral Radiculopathy

Phase 2

Withdrawn

Conditions: Hernia
Pain From Lumbosacral Radiculopathy (PLSR)
10041543

Registration Number: NL-OMON42982

Lead Sponsor: Convergence Pharmaceuticals Ltd., a Biogen company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 28

Inclusion Criteria

1. Is able to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use confidential health information in accordance
with national and local subject privacy regulations.
2. Has completed Study 1014802-203 through the Week 14 (Day 99) visit. Subjects who
discontinued double-blind study treatment but continued to return for study visits through
Week 14 (Day 99) and document their pain scores are eligible unless there are safety
concerns.

Exclusion Criteria

1. Had a major protocol deviation regarding inclusion or exclusion criteria for the doubleblind
Phase 2b study (Study 1014802-203).
2. Had a treatment-related AE or SAE that would pose an increased risk for continued
treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b
study (Study 1014802-203) due to an AE or SAE.
3. Did not return for study visits through Week 14 (Day 99) after discontinuing treatment in
the double-blind phase of the Phase 2b study.
4. Is unable to enroll in the 1014802-204 Study on the 1014802-203 Week 14 (Day 99)
visit.
5. Other unspecified reasons that, in the opinion of the Investigator or Convergence
Pharmaceuticals, make the subject unsuitable for enrollment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints that relate to this objective are as follows:<br /><br>* Adverse events and serious adverse events<br /><br>* Vital signs<br /><br>* Electrocardiogram parameters<br /><br>* Laboratory safety tests<br /><br>* Columbia-Suicide Severity Rating Scale</p><br>

Secondary Outcome Measures