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).
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen. This is an extension study to 1014802-203.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
302
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.
Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
Safety surveillance
Time frame: Up to 395 Days
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.
Time frame: Baseline to Week 52
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.
Time frame: At 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.
Time frame: At 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.
Time frame: Baseline through Week 52
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.
Time frame: Baseline to Week 52
Number of Patient Global Impression of Change (PGIC) responder
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Research Site
Klagenfurt, Austria
Research Site
Leuven, Belgium
Research Site
Blagoevgrad, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Veliko Tarnovo, Bulgaria
Research Site
Beroun, Czechia
...and 41 more locations
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
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.
Time frame: Baseline to Week 52
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.
Time frame: Baseline to Week 52
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.
Time frame: Baseline to Week 52
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).
Time frame: Baseline to Week 52
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.
Time frame: Baseline to Week 52
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.
Time frame: Baseline to Week 52