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

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ClinicalTrials.gov Identifier: NCT02935608
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment Phase
Lumbosacral Radiculopathy Drug: BIIB074 Drug: Placebo Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 31, 2016
Actual Primary Completion Date : August 6, 2018
Actual Study Completion Date : August 6, 2018

Arm Intervention/treatment
Experimental: BIIB074 high dose
Administered twice daily (BID)
Drug: BIIB074
Administered as specified in the treatment arm
Other Name: CNV1014802

Experimental: BIIB074 low dose
Administered BID
Drug: BIIB074
Administered as specified in the treatment arm
Other Name: CNV1014802

Placebo Comparator: Placebo
Placebo administered BID
Drug: Placebo
Matched placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935608


  Show 56 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02935608     History of Changes
Other Study ID Numbers: 1014802-203
2015-004775-78 ( EudraCT Number )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neuralgia
Radiculopathy
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms