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

Primary Purpose

Lumbosacral Radiculopathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIIB074
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbosacral Radiculopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

BIIB074 high dose

BIIB074 low dose

Placebo

Arm Description

Administered twice daily (BID)

Administered BID

Placebo administered BID

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit
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
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."
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.
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.
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.
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).
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.
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.
Amount of rescue medication used per day
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with clinically significant vital sign abnormalities
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Number of participants with clinically significant laboratory assessment abnormalities
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."
Area under the concentration-time curve over the dosing period (AUCtau) at steady state
Maximum concentration (Cmax)

Full Information

First Posted
October 14, 2016
Last Updated
August 14, 2018
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02935608
Brief Title
Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
Acronym
RELAY-1
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
August 6, 2018 (Actual)
Study Completion Date
August 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbosacral Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIIB074 high dose
Arm Type
Experimental
Arm Description
Administered twice daily (BID)
Arm Title
BIIB074 low dose
Arm Type
Experimental
Arm Description
Administered BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered BID
Intervention Type
Drug
Intervention Name(s)
BIIB074
Other Intervention Name(s)
CNV1014802
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Week 14
Secondary Outcome Measure Information:
Title
50% neuropathic daily pain reduction response
Description
Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14.
Time Frame
At Week 14
Title
30% neuropathic daily pain reduction response
Description
Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 14.
Time Frame
At Week 14
Title
Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit
Time Frame
Week 14
Title
Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain
Description
Participants will be asked every evening to rate their overall low back pain for the last 24-hour period
Time Frame
Week 14
Title
Number of Patient Global Impression of Change (PGIC) responders
Description
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."
Time Frame
At Week 14
Title
Change from Baseline to Week 14 on the Oswestry Disability Index
Description
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.
Time Frame
Week 14
Title
Change from Baseline to Week 14 in the weekly average of daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS)
Description
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.
Time Frame
Week 14
Title
Change from Baseline to Week 14 in the Brief Pain Inventory (BPI)- Interference index
Description
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.
Time Frame
Week 14
Title
Change from Baseline to Week 14 in the BPI-Pain index
Description
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).
Time Frame
Week 14
Title
Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
Description
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.
Time Frame
Week 14
Title
Change from Baseline to Week 14 in Short Form 36 Questionnaire (SF-36)
Description
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.
Time Frame
Week 14
Title
Amount of rescue medication used per day
Time Frame
Day 1 to Week 15
Title
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to Week 15
Title
Number of participants with clinically significant vital sign abnormalities
Time Frame
Up to Week 15
Title
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time Frame
Up to Week 15
Title
Number of participants with clinically significant laboratory assessment abnormalities
Time Frame
Up to Week 15
Title
Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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."
Time Frame
Up to Week 15
Title
Area under the concentration-time curve over the dosing period (AUCtau) at steady state
Time Frame
30 min prior to dosing up to 8 hours post dose
Title
Maximum concentration (Cmax)
Time Frame
30 min prior to dosing up to 8 hours post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3212
Country
Belgium
Facility Name
Research Site
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Research Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Research Site
City
Beroun
ZIP/Postal Code
26601
Country
Czechia
Facility Name
Research Site
City
Chocen
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Research Site
City
Litomerice
ZIP/Postal Code
41201
Country
Czechia
Facility Name
Research Site
City
Litomysl
ZIP/Postal Code
57001
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
70200
Country
Czechia
Facility Name
Research Site
City
Prachatice
ZIP/Postal Code
38301
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
10000
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
10034
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
16000
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
179012
Country
Czechia
Facility Name
Research Site
City
Zlin
ZIP/Postal Code
76001
Country
Czechia
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Research Site
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20089
Country
Italy
Facility Name
Research Site
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Research Site
City
Liepaja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
Research Site
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
010584
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
011171
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400437
Country
Romania
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Research Site
City
Banská Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Facility Name
Research Site
City
Dolný Kubín
ZIP/Postal Code
026 01
Country
Slovakia
Facility Name
Reasearch Site
City
Dubnica nad Váhom
ZIP/Postal Code
018 41
Country
Slovakia
Facility Name
Research Site
City
Krompachy
ZIP/Postal Code
053 42
Country
Slovakia
Facility Name
Research Site
City
Pruske
ZIP/Postal Code
01852
Country
Slovakia
Facility Name
Research Site
City
Spišská Nová Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Elche
ZIP/Postal Code
03293
Country
Spain
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28690
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L9 7LI
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

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Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy

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