Neuropathic Pain From Lumbosacral RadiculopathyPhase 2RELAY-1 ExtendNCT02957617
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074
A Phase 2 study testing BIIB074 in people with Neuropathic Pain From Lumbosacral Radiculopathy, run by Biogen at 51 sites in 14 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain From Lumbosacral Radiculopathy
- What is being tested?
- BIIB074
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 51 sitesin 14 countries
- Study dates
- 10 Feb 2017to 7 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has completed Study 1014802-203 for its complete duration.
Who cannot join
- 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
Trial locations and contacts
51 sites in 14 countries.
51 sites in 14 countries
Czechia11 sites
Research Site
Beroun, 26601
Research Site
Choceň, 56501
Research Site
Litoměřice, 41201
Research Site
Litomyšl, 57001
Research Site
Ostrava, 70200
Research Site
Prachatice, 38301
Research Site
Prague, 10000
Research Site
Prague, 14000
Research Site
Prague, 16000
Research Site
Prague, 179012
Research Site
Zlín, 76001
Bulgaria7 sites
Research Site
Blagoevgrad, 2700
Research Site
Rousse, 7003
Research Site
Sofia, 1000
Research Site
Sofia, 1431
Research Site
Sofia, 1784
Research Site
Sofia, 4001
Research Site
Veliko Tarnovo, 5000
Spain6 sites
Research Site
Barcelona, 08907
Research Site
Granada, 18014
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Madrid, 28690
Research Site
Madrid, 28938
Slovakia5 sites
Research Site
Banská Bystrica, 974 04
Research Site
Dubnica nad Váhom, 018 41
Research Site
Krompachy, 053 42
Research Site
Pruské, 01852
Research Site
Spišská Nová Ves, 052 01
Georgia4 sites
Research Site
Tbilisi, 0144
Research Site
Tbilisi, 0160
Research Site
Tbilisi, 0179
Research Site
Tbilisi, 0186
United Kingdom4 sites
Research Site
Edinburgh, EH4 2XU
Research Site
Liverpool, L9 7LI
Research Site
London, NW3 2QG
Research Site
London, SE1 7EH
Latvia3 sites
Research Site
Liepāja, LV-3414
Research Site
Riga, LV-1002
Research Site
Riga, LV-1003
Romania3 sites
Research Site
Bucharest, 010584
Research Site
Cluj-Napoca, 400437
Research Site
Craiova, 200642
Serbia3 sites
Research Site 1
Belgrade, 11000
Research Site 2
Belgrade, 11000
Research Site
Belgrade, 21000
About this study
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
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).
Read the 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.
- Being tested
- BIIB074
- Keywords
- Neuropathic Pain From Lumbosacral Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB074Drug
Also called CNV1014802
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.
| Study group | Role | What they receive |
|---|---|---|
| BIIB074 | Experimental | BIIB074 orally twice daily Receives: Drug: BIIB074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
Safety surveillance
Measured: Up to 395 Days
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 52
Number of Patient Global Impression of Change (PGIC) responder
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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start10 Feb 2017
- Primary completion7 Feb 2019
- Study completion7 Feb 2019
Why it stopped: The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain From Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957617
- Sponsor's protocol ID
- 1014802-204
- Other IDs
- 2015-004796-68, 2015
- Acronym
- RELAY-1 Extend
- Status last verified
- Feb 2019
- First submitted
- 14 Oct 2016
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02957617
- Acronym / sponsor ID
- RELAY-1 Extend / 1014802-204
- Keywords
- Neuropathic Pain From Lumbosacral Radiculopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.
- Enrolment
- 302 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 7 Feb 2019 (actual)
- Study completion
- 7 Feb 2019 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIIB074 | Experimental | Drug: BIIB074BIIB074 orally twice daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has completed Study 1014802-203 for its complete duration.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIIB074Also: CNV1014802Participants 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. | Drug | BIIB074 |
Primary outcome
Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)
Time frame: Up to 395 Days
Safety surveillance
12 secondary outcomes
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
50% neuropathic pain reduction response
Time frame: At Week 52
30% neuropathic pain reduction response
Time frame: 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
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
Number of Patient Global Impression of Change (PGIC) responder
Time frame: At Week 52
Change from Baseline to Week 52 on the Oswestry Disability Index (ODI)
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)
Time frame: Baseline to Week 52
Change from Baseline to Week 52 in the Brief Pain Inventory (BPI)-Interference Index
Time frame: Baseline to Week 52
Change from Baseline to Week 52 in the BPI - Pain Index
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
Time frame: Baseline to Week 52
Change from Baseline to Week 52 in Short Form 36 Questionnaire (SF-36)
Time frame: Baseline to Week 52
Results and safety
The study was stopped early (reason given: The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
Related trials for Neuropathic Pain From Lumbosacral Radiculopathy
Recruiting
TFESI and Neuropathic Pain in Lumbosacral Radiculopathy
Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
51 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB074 in people with Neuropathic Pain From Lumbosacral Radiculopathy, run by Biogen at 51 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Czechia, Bulgaria, Spain, Slovakia, Georgia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The parent study did not meet its primary or secondary efficacy endpoints and therefore Sponsor decision to discontinue development in this indication.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs) (time frame: Up to 395 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.