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

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ClinicalTrials.gov Identifier: NCT02957617
Recruitment Status : Terminated (The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.)
First Posted : November 8, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

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).

Condition or disease Intervention/treatment Phase
Neuropathic Pain From Lumbosacral Radiculopathy Drug: BIIB074 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 10, 2017
Actual Primary Completion Date : February 7, 2019
Actual Study Completion Date : February 7, 2019

Arm Intervention/treatment
Experimental: BIIB074
BIIB074 orally twice daily
Drug: BIIB074
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.
Other Name: CNV1014802




Primary Outcome Measures :
  1. Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs) [ Time Frame: Up to 395 Days ]
    Safety surveillance


Secondary Outcome Measures :
  1. 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) [ Time Frame: Baseline to Week 52 ]
    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.

  2. 50% neuropathic pain reduction response [ Time Frame: At Week 52 ]
    Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 52.

  3. 30% neuropathic pain reduction response [ Time Frame: At Week 52 ]
    Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to week 52.

  4. Change from Baseline at each visit in the weekly average of the daily neuropathic pain score [ Time Frame: Baseline through Week 52 ]
    Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period.

  5. Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain [ Time Frame: Baseline to Week 52 ]
    Participants will be asked every evening to rate their overall low back pain for the last 24-hour period.

  6. Number of Patient Global Impression of Change (PGIC) responder [ Time Frame: At Week 52 ]
    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."

  7. Change from Baseline to Week 52 on the Oswestry Disability Index (ODI) [ Time Frame: Baseline to Week 52 ]
    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.

  8. 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) [ Time Frame: Baseline to Week 52 ]
    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.

  9. Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference Index [ Time Frame: Baseline to Week 52 ]
    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.

  10. Change from Baseline to Week 52 in the BPI - Pain Index [ Time Frame: Baseline to Week 52 ]
    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).

  11. Change from Baseline to Week 52 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index [ Time Frame: Baseline to Week 52 ]
    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.

  12. Change from Baseline to Week 52 in Short Form 36 Questionnaire (SF-36) [ Time Frame: Baseline to Week 52 ]
    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.



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 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


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): NCT02957617


  Show 51 Study Locations
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02957617     History of Changes
Other Study ID Numbers: 1014802-204
2015-004796-68 ( EudraCT Number )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biogen:
Neuropathic Pain From Lumbosacral Radiculopathy
Additional relevant MeSH terms:
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Neuralgia
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms