Study to Evaluate the Long Term Safety, Tolerability, and Effect of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

Phase 1

• Conditions: europathic PainFrom Lumbosacral Radiculopathy; MedDRA version: 19.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0Level: PTClassification code 10050219Term: Lumbar radiculopathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004796-68-NL
• Lead Sponsor: Convergence Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-07
• Study Completion: 2019-02-07
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

The candidates must meet the following eligibility criteria at enrollment, or at the timepoint specified in the individual eligibility criterion listed:
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 323
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria exist at enrollment, or at the timepoint specified in the individual criterion listed:
1.Had a major protocol deviation regarding inclusion or exclusion criteria for the double-blind 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the long term safety and tolerability of BIIB074 in subjects with neuropathic PLSR.;Secondary Objective: Secondary objectives of the study are:<br>- To investigate the maintenance of effect during long-term treatment with BIIB074 in subjects with neuropathic PLSR<br>-To evaluate the impact of treatment with BIIB074 on quality of life;Primary end point(s): The primary endpoints that relate to this objective are as follows:<br>1.AEs and SAEs<br>2.Vital signs<br>3.ECG parameters<br>4.Laboratory safety tests<br>5.Columbia-Suicide Severity Rating Scale (C-SSRS)<br>;Timepoint(s) of evaluation of this end point: 1.-5.From Enrolment at all study visits (w.2, 4, 13, 26, 39, 52 and FU)