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Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074 (RELAY-1 Extend)

Primary Purpose

Neuropathic Pain From Lumbosacral Radiculopathy

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

About this trial

This is an interventional treatment trial for Neuropathic Pain From Lumbosacral Radiculopathy focused on measuring Neuropathic Pain From Lumbosacral Radiculopathy

Eligibility Criteria

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

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIIB074

Arm Description

BIIB074 orally twice daily

Outcomes

Primary Outcome Measures

Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
Safety surveillance

Secondary Outcome Measures

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)
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=worst possible pain.
50% neuropathic pain reduction response
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
Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to week 52.
Change from Baseline at each visit in the weekly average of the daily neuropathic pain score
Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period.
Change from Baseline to Week 52 in the 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) responder
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 52 on the Oswestry Disability Index (ODI)
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 52 in the weekly average of the 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=worst possible pain.
Change from Baseline to Week 52 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 52 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 52 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
The EQ-5D-5L 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 52 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.

Full Information

First Posted
October 14, 2016
Last Updated
February 22, 2019
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02957617
Brief Title
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074
Acronym
RELAY-1 Extend
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 7, 2019 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain From Lumbosacral Radiculopathy
Keywords
Neuropathic Pain From Lumbosacral Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIIB074
Arm Type
Experimental
Arm Description
BIIB074 orally twice daily
Intervention Type
Drug
Intervention Name(s)
BIIB074
Other Intervention Name(s)
CNV1014802
Intervention Description
Participants will receive an initial dose regimen of 350mg orally twice daily (BID), which may be reduced to 200mg based on tolerability for up to 12 months.
Primary Outcome Measure Information:
Title
Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
Description
Safety surveillance
Time Frame
Up to 395 Days
Secondary Outcome Measure Information:
Title
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)
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=worst possible pain.
Time Frame
Baseline to Week 52
Title
50% neuropathic pain reduction response
Description
Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52.
Time Frame
At Week 52
Title
30% neuropathic 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 52.
Time Frame
At Week 52
Title
Change from Baseline at each visit in the weekly average of the daily neuropathic pain score
Description
Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period.
Time Frame
Baseline through Week 52
Title
Change from Baseline to Week 52 in the 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
Baseline to Week 52
Title
Number of Patient Global Impression of Change (PGIC) responder
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 52
Title
Change from Baseline to Week 52 on the Oswestry Disability Index (ODI)
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
Baseline to Week 52
Title
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)
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=worst possible pain.
Time Frame
Baseline to Week 52
Title
Change from Baseline to Week 52 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
Baseline to Week 52
Title
Change from Baseline to Week 52 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
Baseline to Week 52
Title
Change from Baseline to Week 52 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
Description
The EQ-5D-5L 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
Baseline to Week 52
Title
Change from Baseline to Week 52 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
Baseline to Week 52

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 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
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
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
Tartu
ZIP/Postal Code
51014
Country
Estonia
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
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
Bucharest
ZIP/Postal Code
010584
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 1
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site 2
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
Banska Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Facility Name
Research Site
City
Dubnica nad Vahom
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
Spisska Nova 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
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
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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Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074

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