Lumbosacral RadiculopathyPhase 2RELAY-1NCT02935608
Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
A Phase 2 study testing BIIB074 in people with Lumbosacral Radiculopathy, run by Biogen at 56 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- BIIB074
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 56 sitesin 14 countries
- Study dates
- 31 Oct 2016to 6 Aug 2018
- 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 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
Who cannot join
- 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.
Trial locations and contacts
56 sites in 14 countries.
56 sites in 14 countries
Czechia12 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, 10034
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
Spain7 sites
Research Site
Barcelona, 08907
Research Site
Elche, 03293
Research Site
Granada, 18014
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Madrid, 28690
Research Site
Madrid, 28938
Slovakia6 sites
Research Site
Banská Bystrica, 974 04
Research Site
Dolný Kubín, 026 01
Reasearch Site
Dubnica nad Váhom, 018 41
Research Site
Krompachy, 053 42
Research Site
Pruské, 01852
Research Site
Spišská Nová Ves, 052 01
United Kingdom5 sites
Research Site
Birmingham, B15 2TH
Research Site
Edinburgh, EH4 2XU
Research Site
Liverpool, L9 7LI
Research Site
London, NW3 2QG
Research Site
London, SE1 7EH
Georgia4 sites
Research Site
Tbilisi, 0144
Research Site
Tbilisi, 0160
Research Site
Tbilisi, 0179
Research Site
Tbilisi, 0186
Romania4 sites
Research Site
Bucharest, 010584
Research Site
Bucharest, 011171
Research Site
Cluj-Napoca, 400437
Research Site
Craiova, 200642
Latvia3 sites
Research Site
Liepāja, LV-3414
Research Site
Riga, LV-1002
Research Site
Riga, LV-1003
About this study
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
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.
Read the detailed description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- BIIB074, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB074Drug
Also called CNV1014802
Administered as specified in the treatment arm
PlaceboDrug
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| BIIB074 high dose | Experimental | Administered twice daily (BID) Receives: Drug: BIIB074 |
| BIIB074 low dose | Experimental | Administered BID Receives: Drug: BIIB074 |
| Placebo | Placebo comparator | Placebo administered BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
Measured: Week 14
Secondary outcomes (19)
50% neuropathic daily pain reduction response
Response is defined as a ≥50% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14.
Measured: At Week 14
30% neuropathic daily pain reduction response
Response is defined as a ≥30% reduction in the weekly average of the daily neuropathic pain score from Baseline to Week 14.
Measured: At Week 14
Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit
Measured: Week 14
Change from Baseline to Week 14 in 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: Week 14
Number of Patient Global Impression of Change (PGIC) responders
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 14
Change from Baseline to Week 14 on the Oswestry Disability Index
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: Week 14
Change from Baseline to Week 14 in the weekly average of 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=Pain completely interfered with sleep.
Measured: Week 14
Change from Baseline to Week 14 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: Week 14
Change from Baseline to Week 14 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: Week 14
Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
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.
Measured: Week 14
Change from Baseline to Week 14 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: Week 14
Amount of rescue medication used per day
Measured: Day 1 to Week 15
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Week 15
Number of participants with clinically significant vital sign abnormalities
Measured: Up to Week 15
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Measured: Up to Week 15
Number of participants with clinically significant laboratory assessment abnormalities
Measured: Up to Week 15
Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
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."
Measured: Up to Week 15
Area under the concentration-time curve over the dosing period (AUCtau) at steady state
Measured: 30 min prior to dosing up to 8 hours post dose
Maximum concentration (Cmax)
Measured: 30 min prior to dosing up to 8 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start31 Oct 2016
- Primary completion6 Aug 2018
- Study completion6 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 502 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
- NCT02935608
- Sponsor's protocol ID
- 1014802-203
- Other IDs
- 2015-004775-78, 2015
- Acronym
- RELAY-1
- Status last verified
- Aug 2018
- First submitted
- 14 Oct 2016
- Last updated
- 15 Aug 2018
- 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 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02935608
- Acronym / sponsor ID
- RELAY-1 / 1014802-203
- Conditions
- Lumbosacral Radiculopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 17 Oct 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 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.
Detailed description
This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIIB074 high dose | Experimental | Drug: BIIB074Administered twice daily (BID) |
| BIIB074 low dose | Experimental | Drug: BIIB074Administered BID |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered BID |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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.
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: CNV1014802Administered as specified in the treatment arm | Drug | BIIB074 high dose, BIIB074 low dose |
| PlaceboMatched placebo | Drug | Placebo |
Primary outcome
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.
19 secondary outcomes
50% neuropathic daily pain reduction response
Time frame: At Week 14
30% neuropathic daily pain reduction response
Time frame: At Week 14
Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit
Time frame: Week 14
Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain
Time frame: Week 14
Number of Patient Global Impression of Change (PGIC) responders
Time frame: At Week 14
Change from Baseline to Week 14 on the Oswestry Disability Index
Time frame: Week 14
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
Change from Baseline to Week 14 in the Brief Pain Inventory (BPI)- Interference index
Time frame: Week 14
Change from Baseline to Week 14 in the BPI-Pain index
Time frame: Week 14
Change from Baseline to Week 14 on the EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) health index
Time frame: Week 14
Change from Baseline to Week 14 in Short Form 36 Questionnaire (SF-36)
Time frame: Week 14
Amount of rescue medication used per day
Time frame: Day 1 to Week 15
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 15
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to Week 15
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to Week 15
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to Week 15
Safety and Tolerability as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 15
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
Maximum concentration (Cmax)
Time frame: 30 min prior to dosing up to 8 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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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
56 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 Lumbosacral Radiculopathy, run by Biogen at 56 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Czechia, Bulgaria, Spain, Slovakia, United Kingdom 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 15 Aug 2018.