Clinical trial NCT02935608: Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbosacral Radiculopathy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.

Detailed description: This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Eligibility criteria: Key Inclusion Criteria:

* Has body weight ≥50 kg for men and ≥45 kg for women
* Must have diagnosis of neuropathic PLSR
* Has duration of neuropathic (leg) pain of at least 6 months before Screening
* Has an intensity of ≥4 and ≤9 on the Numerical Rating Scale based on a paper-based question at Screening and on Day 1 that asks for the average pain intensity of neuropathic (leg) pain due to PLSR over the last week

Key Exclusion Criteria:

* Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)
* Has a history of peripheral neuropathy (e.g., due to diabetes, alcohol consumption, other causes, or idiopathic) or evidence of peripheral neuropathy upon neurological examination
* Has a history or risk of seizures or a history of epilepsy, clinically significant head injury, or related neurological disorders

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)
timeFrame: Week 14
Secondary outcomes:
measure: 50% neuropathic daily pain reduction response
timeFrame: At Week 14
measure: 30% neuropathic daily pain reduction response
timeFrame: At Week 14
measure: Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit
timeFrame: Week 14
measure: Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain
timeFrame: Week 14
measure: Number of Patient Global Impression of Change (PGIC) responders
timeFrame: At Week 14
measure: Change from Baseline to Week 14 on the Oswestry Disability Index
timeFrame: Week 14
measure: Change from Baseline to Week 14 in the weekly average of daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS)
timeFrame: Week 14
measure: Change from Baseline to Week 14 in the Brief Pain Inventory (BPI)- Interference index
timeFrame: Week 14
measure: Change from Baseline to Week 14 in the BPI-Pain index
timeFrame: Week 14
measure: Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
timeFrame: Week 14
measure: Change from Baseline to Week 14 in Short Form 36 Questionnaire (SF-36)
timeFrame: Week 14
measure: Amount of rescue medication used per day
timeFrame: Day 1 to Week 15
measure: Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 15
measure: Number of participants with clinically significant vital sign abnormalities
timeFrame: Up to Week 15
measure: Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
timeFrame: Up to Week 15
measure: Number of participants with clinically significant laboratory assessment abnormalities
timeFrame: Up to Week 15
measure: Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to Week 15
measure: Area under the concentration-time curve over the dosing period (AUCtau) at steady state
timeFrame: 30 min prior to dosing up to 8 hours post dose
measure: Maximum concentration (Cmax)
timeFrame: 30 min prior to dosing up to 8 hours post dose
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: Prague
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
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: Milan
country: Italy
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: Nieuwegein
country: Netherlands
facility: Research Site
city: Bucharest
country: Romania
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
city: Belgrade
country: Serbia
facility: Research Site
city: Banská Bystrica
country: Slovakia
facility: Research Site
city: Dolný Kubín
country: Slovakia
facility: Research Site
city: Dubnica nad Váhom
country: Slovakia
facility: Reasearch Site
city: Krompachy
country: Slovakia
facility: Research Site
city: Pruske
country: Slovakia
facility: Research Site
city: Spišská Nová Ves
country: Slovakia
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Elche
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: Birmingham
country: United Kingdom
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: