Clinical trial NCT02957617: Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074
Official title: An Uncontrolled, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (Vixotrigine) in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuropathic Pain From Lumbosacral Radiculopathy
Keywords: Neuropathic Pain From Lumbosacral Radiculopathy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-11-08
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen. This is an extension study to 1014802-203.

Eligibility criteria: Key Inclusion Criteria:

* Has completed Study 1014802-203 for its complete duration.

Key Exclusion Criteria:

* Has met an exclusion criterion for the preceding double-blind Phase 2b study (Study 1014802-203).
* Had a protocol deviation regarding inclusion or exclusion criteria for the double-blind Phase 2b study (Study 1014802-203).
* 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.
* Did not return for all study visits after discontinuing treatment in the double-blind phase of the Phase 2b study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
timeFrame: Up to 395 Days
Secondary outcomes:
measure: Change from Baseline to Week 52 in the weekly average of the daily neuropathic pain score on the Pain Intensity Numerical Rating Scale (PI-NRS)
timeFrame: Baseline to Week 52
measure: 50% neuropathic pain reduction response
timeFrame: At Week 52
measure: 30% neuropathic pain reduction response
timeFrame: At Week 52
measure: Change from Baseline at each visit in the weekly average of the daily neuropathic pain score
timeFrame: Baseline through Week 52
measure: Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain
timeFrame: Baseline to Week 52
measure: Number of Patient Global Impression of Change (PGIC) responder
timeFrame: At Week 52
measure: Change from Baseline to Week 52 on the Oswestry Disability Index (ODI)
timeFrame: Baseline to Week 52
measure: Change from Baseline to Week 52 in the weekly average of the daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS)
timeFrame: Baseline to Week 52
measure: Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference Index
timeFrame: Baseline to Week 52
measure: Change from Baseline to Week 52 in the BPI - Pain Index
timeFrame: Baseline to Week 52
measure: Change from Baseline to Week 52 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
timeFrame: Baseline to Week 52
measure: Change from Baseline to Week 52 in Short Form 36 Questionnaire (SF-36)
timeFrame: Baseline to Week 52
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Beroun
country: Czechia
facility: Research Site
city: Chocen
country: Czechia
facility: Research Site
city: Litomerice
country: Czechia
facility: Research Site
city: Litomysl
country: Czechia
facility: Research Site
city: Ostrava
country: Czechia
facility: Research Site
city: Prachatice
country: Czechia
facility: Research Site
city: Prague
country: Czechia
facility: Research Site
city: Prague
country: Czechia
facility: Research Site
city: Prague
country: Czechia
facility: Research Site
city: Prague
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site 1
city: Belgrade
country: Serbia
facility: Research Site 2
city: Belgrade
country: Serbia
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Dubnica nad Vahom
country: Slovakia
facility: Research Site
city: Krompachy
country: Slovakia
facility: Research Site
city: Pruske
country: Slovakia
facility: Research Site
city: Spisska Nova Ves
country: Slovakia
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: