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NCT Number: NCT02935608

Study to Evaluate the Efficacy and Safety of BIIB074 in 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.

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Key information

Conditions

Lumbosacral Radiculopathy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Klagenfurt, Austria

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB074

Drug

Administered as specified in the treatment arm

Other names: CNV1014802

Placebo

Drug

Matched placebo

Primary outcomes

  1. 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)

    Time frame: Week 14

    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 outcomes

  1. 50% neuropathic daily pain reduction response

    Time frame: At Week 14

    Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14.

  2. 30% neuropathic daily pain reduction response

    Time frame: At Week 14

    Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 14.

  3. Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit

    Time frame: Week 14

  4. Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain

    Time frame: Week 14

    Participants will be asked every evening to rate their overall low back pain for the last 24-hour period

  5. Number of Patient Global Impression of Change (PGIC) responders

    Time frame: At Week 14

    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."

  6. Change from Baseline to Week 14 on the Oswestry Disability Index

    Time frame: Week 14

    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.

  7. Change from Baseline to Week 14 in the weekly average of daily sleep score as assessed by the Sleep Numerical Rating Scale (S-NRS)

    Time frame: Week 14

    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.

  8. Change from Baseline to Week 14 in the Brief Pain Inventory (BPI)- Interference index

    Time frame: Week 14

    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.

  9. Change from Baseline to Week 14 in the BPI-Pain index

    Time frame: Week 14

    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).

  10. Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index

    Time frame: Week 14

    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.

  11. Change from Baseline to Week 14 in Short Form 36 Questionnaire (SF-36)

    Time frame: Week 14

    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.

  12. Amount of rescue medication used per day

    Time frame: Day 1 to Week 15

  13. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Week 15

  14. Number of participants with clinically significant vital sign abnormalities

    Time frame: Up to Week 15

  15. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

    Time frame: Up to Week 15

  16. Number of participants with clinically significant laboratory assessment abnormalities

    Time frame: Up to Week 15

  17. Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to Week 15

    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."

  18. 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

  19. Maximum concentration (Cmax)

    Time frame: 30 min prior to dosing up to 8 hours post dose

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Acronym: RELAY-1

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2016
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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