Hernia Pain From Lumbosacral Radiculopathy (PLSR)
Conditions
Interventions
Subjects will receive an initial dose regimen of 350 mg twice daily (BID) of
BIIB074, which may be reduced to 200 mg BID based on tolerability.
Leg pain NRS
Lumbosacral radiculopathy
Neuropathic pain
Sodium channel blocker
Sponsors
Convergence Pharmaceuticals Ltd., a Biogen company
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints that relate to this objective are as follows: * Adverse events and serious adverse events * Vital signs * Electrocardiogram parameters * Laboratory safety tests * Columbia-Suicide Severity Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives and endpoints are as follows: To investigate the maintenance of effect during long-term treatment with BIIB074 in subjects with neuropathic PLSR. For all efficacy assessments, Baseline will be the 1-week period prior to randomization (at Day 15, Week 2) into Study 1014802-203. * Efficacy endpoints in neuropathic pain: * Change from Baseline to Week 52 in the weekly average of the daily neuropathicpain* score on the 11-point Pain IntensityNumerical Rating Scale; subjects will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. *Neuropathic pain will be evaluated in the worse affected leg, as identified on Day 1 of Study 1014802-203 * 50% neuropathic pain reduction response (yes/no) at Week 52, where a response is defined as a *50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52 * 30% neuropathic pain reduction response (yes/no) at Week 52, where a response is defined as a *30% reduction in the weeklyaverage of the daily neuropathic pain score from Baseline to Week 52 * Changes from Baseline in the weekly average of the daily neuropathic pain score at each visit * Efficacy endpoint in low back pain: * Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain; subjects will be asked everyevening to rate their overall low back pain for the last 24-hour period To evaluate the impact of treatment with BIIB074 on quality of life * Patient Global Impression of Change responder (yes/no) at Week 52, where a responder is defined as either *much improved* or *very much improved* * Change from Baseline to Week 52 on the Oswestry Disability Index * Change from Baseline to Week 52 in the weekly average of the daily sleep score; subjects will be asked every morning to rate on the 11-point Sleep Numerical Rating Scale how leg pain interfered with their sleep quality * Change from Baseline to Week 52 in the Brie | — |
Countries
Austria, Belgium, Bulgaria, Czechia, France, Georgia, Italy, Latvia, Netherlands, Romania, Serbia, Slovakia, Spain, United Kingdom, United States of America
Outcome results
None listed