Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy (RELAY-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbosacral Radiculopathy
• Intervention / Treatment: Drug: Placebo; Drug: BIIB074

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 502
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Klagenfurt, Austria, 9020
    • Research Site
• Belgium
  • Leuven, Belgium, 3212
    • Research Site
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Research Site
  • Ruse, Bulgaria, 7003
    • Research Site
  • Sofia, Bulgaria, 1000
    • Research Site
  • Sofia, Bulgaria, 1431
    • Research Site
  • Sofia, Bulgaria, 1784
    • Research Site
  • Sofia, Bulgaria, 4001
    • Research Site
  • Veliko Tarnovo, Bulgaria, 5000
    • Research Site
• Czechia
  • Beroun, Czechia, 26601
    • Research Site
  • Chocen, Czechia, 56501
    • Research Site
  • Litomerice, Czechia, 41201
    • Research Site
  • Litomysl, Czechia, 57001
    • Research Site
  • Ostrava, Czechia, 70200
    • Research Site
  • Prachatice, Czechia, 38301
    • Research Site
  • Prague, Czechia, 10000
    • Research Site
  • Prague, Czechia, 10034
    • Research Site
  • Prague, Czechia, 14000
    • Research Site
  • Prague, Czechia, 16000
    • Research Site
  • Prague, Czechia, 179012
    • Research Site
  • Zlin, Czechia, 76001
    • Research Site
• France
  • Paris, France, 75014
    • Research Site
• Georgia
  • Tbilisi, Georgia, 0144
    • Research Site
  • Tbilisi, Georgia, 0160
    • Research Site
  • Tbilisi, Georgia, 0179
    • Research Site
  • Tbilisi, Georgia, 0186
    • Research Site
• Italy
  • Milan, Italy, 20089
    • Research Site
  • Rome, Italy, 00161
    • Research Site
• Latvia
  • Liepaja, Latvia, LV-3414
    • Research Site
  • Riga, Latvia, LV-1002
    • Research Site
  • Riga, Latvia, LV-1003
    • Research Site
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • Research Site
• Romania
  • Bucharest, Romania, 010584
    • Research Site
  • Bucharest, Romania, 011171
    • Research Site
  • Cluj-Napoca, Romania, 400437
    • Research Site
  • Craiova, Romania, 200642
    • Research Site
• Serbia
  • Belgrade, Serbia, 11000
    • Research Site
  • Belgrade, Serbia, 21000
    • Research Site
• Slovakia
  • Banská Bystrica, Slovakia, 974 04
    • Research Site
  • Dolný Kubín, Slovakia, 026 01
    • Research Site
  • Dubnica nad Váhom, Slovakia, 018 41
    • Reasearch Site
  • Krompachy, Slovakia, 053 42
    • Research Site
  • Pruske, Slovakia, 01852
    • Research Site
  • Spišská Nová Ves, Slovakia, 052 01
    • Research Site
• Spain
  • Barcelona, Spain, 08907
    • Research Site
  • Elche, Spain, 03293
    • Research Site
  • Granada, Spain, 18014
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 28690
    • Research Site
  • Madrid, Spain, 28938
    • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Research Site
  • Edinburgh, United Kingdom, EH4 2XU
    • Research Site
  • Liverpool, United Kingdom, L9 7LI
    • Research Site
  • London, United Kingdom, SE1 7EH
    • Research Site
  • London, United Kingdom, NW3 2QG
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIIB074 high dose; Administered twice daily (BID)	Drug: BIIB074; Administered as specified in the treatment arm; Other Names: CNV1014802
Experimental: BIIB074 low dose; Administered BID	Drug: BIIB074; Administered as specified in the treatment arm; Other Names: CNV1014802
Placebo Comparator: Placebo; Placebo administered BID	Drug: Placebo; Matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. PI-NRS is an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=pain as bad as you can imagine.	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
50% neuropathic daily pain reduction response	Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14.	At Week 14
30% neuropathic daily pain reduction response	Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 14.	At Week 14
Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit		Week 14
Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain	Participants will be asked every evening to rate their overall low back pain for the last 24-hour period	Week 14
Number of Patient Global Impression of Change (PGIC) responders	PGIC is a 7-point, self-report scale depicting a participant's rating of overall improvement. Participants rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."	At Week 14
Change from Baseline to Week 14 on the Oswestry Disability Index	This is a 10-item questionnaire that evaluates how back (or leg) pain affects the ability to manage in everyday life. Each question is rated on a 5 point scale with higher scores indicating higher level of pain.	Week 14
Change from Baseline to Week 14 in the weekly average of daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS)	Participants will be asked every morning to rate on the 11-point S-NRS how leg pain interfered with their sleep quality, where 0=no pain and 10=Pain completely interfered with sleep.	Week 14
Change from Baseline to Week 14 in the Brief Pain Inventory (BPI)- Interference index	BPI Interference Index is an 11-point numeric rating scale (0 - no interference to 10 - interferes completely) to assess pain-related interference in 7 areas: general activity, mood, walking ability, normal work, including outside the home and housework, relations with other people, enjoyment of life and sleep.	Week 14
Change from Baseline to Week 14 in the BPI-Pain index	BPI- Pain Index for pain intensity is used to assess potential pain quality descriptors that may describe participants' pain on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).	Week 14
Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index	The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.	Week 14
Change from Baseline to Week 14 in Short Form 36 Questionnaire (SF-36)	SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health.	Week 14
Amount of rescue medication used per day		Day 1 to Week 15
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to Week 15
Number of participants with clinically significant vital sign abnormalities		Up to Week 15
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities		Up to Week 15
Number of participants with clinically significant laboratory assessment abnormalities		Up to Week 15
Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a suicidal ideation rating used to evaluate suicidality in children ages 12 and up. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."	Up to Week 15
Area under the concentration-time curve over the dosing period (AUCtau) at steady state		30 min prior to dosing up to 8 hours post dose
Maximum concentration (Cmax)		30 min prior to dosing up to 8 hours post dose

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2016
• Primary Completion (Actual): August 6, 2018
• Study Completion (Actual): August 6, 2018

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Radiculopathy
• Other Study ID Numbers: 1014802-203; 2015-004775-78 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No