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

February 22, 2019 updated by: Biogen

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Klagenfurt, Austria, 9020
        • Research Site
  • Belgium
      • Leuven, Belgium, 3212
        • Research Site
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Research Site
      • Ruse, Bulgaria, 7003
        • Research Site
      • Sofia, Bulgaria, 1000
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1784
        • Research Site
      • Sofia, Bulgaria, 4001
        • Research Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Research Site
  • Czechia
      • Beroun, Czechia, 26601
        • Research Site
      • Chocen, Czechia, 56501
        • Research Site
      • Litomerice, Czechia, 41201
        • Research Site
      • Litomysl, Czechia, 57001
        • Research Site
      • Ostrava, Czechia, 70200
        • Research Site
      • Prachatice, Czechia, 38301
        • Research Site
      • Prague, Czechia, 10000
        • Research Site
      • Prague, Czechia, 14000
        • Research Site
      • Prague, Czechia, 16000
        • Research Site
      • Prague, Czechia, 179012
        • Research Site
      • Zlin, Czechia, 76001
        • Research Site
  • Estonia
      • Tartu, Estonia, 51014
        • Research Site
  • France
      • Paris, France, 75014
        • Research Site
  • Georgia
      • Tbilisi, Georgia, 0144
        • Research Site
      • Tbilisi, Georgia, 0160
        • Research Site
      • Tbilisi, Georgia, 0179
        • Research Site
      • Tbilisi, Georgia, 0186
        • Research Site
  • Italy
      • Rome, Italy, 00161
        • Research Site
  • Latvia
      • Liepaja, Latvia, LV-3414
        • Research Site
      • Riga, Latvia, LV-1002
        • Research Site
      • Riga, Latvia, LV-1003
        • Research Site
  • Romania
      • Bucharest, Romania, 010584
        • Research Site
      • Cluj-Napoca, Romania, 400437
        • Research Site
      • Craiova, Romania, 200642
        • Research Site
  • Serbia
      • Belgrade, Serbia, 21000
        • Research Site
      • Belgrade, Serbia, 11000
        • Research Site 1
      • Belgrade, Serbia, 11000
        • Research Site 2
  • Slovakia
      • Banska Bystrica, Slovakia, 974 04
        • Research Site
      • Dubnica nad Vahom, Slovakia, 018 41
        • Research Site
      • Krompachy, Slovakia, 053 42
        • Research Site
      • Pruske, Slovakia, 01852
        • Research Site
      • Spisska Nova Ves, Slovakia, 052 01
        • Research Site
  • Spain
      • Barcelona, Spain, 08907
        • Research Site
      • Granada, Spain, 18014
        • Research Site
      • Madrid, Spain, 28046
        • Research Site
      • Madrid, Spain, 28040
        • Research Site
      • Madrid, Spain, 28690
        • Research Site
      • Madrid, Spain, 28938
        • Research Site
  • United Kingdom
      • Edinburgh, United Kingdom, EH4 2XU
        • Research Site
      • Liverpool, United Kingdom, L9 7LI
        • Research Site
      • London, United Kingdom, SE1 7EH
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • CNV1014802

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
Time Frame: Up to 395 Days
Safety surveillance
Up to 395 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 52
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.
At Week 52
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.
At Week 52
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.
Baseline through Week 52
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.
Baseline to Week 52
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."
At Week 52
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.
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)
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.
Baseline to Week 52
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.
Baseline to Week 52
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).
Baseline to Week 52
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.
Baseline to Week 52
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.
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2017

Primary Completion (Actual)

February 7, 2019

Study Completion (Actual)

February 7, 2019

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1014802-204
  • 2015-004796-68 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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