Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004775-78-GB

Enrollment

504

Registered

2016-04-13

Start date

2016-07-20

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain From Lumbosacral Radiculopathy MedDRA version: 20.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 100000014315 MedDRA version: 20.0 Level: PT Classification code 10050219 Term: Lumbar radiculopathy System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: BIIB074 Product Code: BIIB074 Pharmaceutical Form: Coated tablet INN or Proposed INN: Raxatrigine (proposed) CAS Number: 9

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key Inclusion Criteria: - Men and women aged 18 to 75 years inclusive - 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 Other protocol-defined inclusion/exclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 104

Exclusion criteria

Exclusion criteria: Key Exclusion Criteria: - Has pain of a different type in the legs (e.g. due to arthritis) that may interfere with the assessment of neuropathic pain in legs. - Has planned surgical intervention for PLSR within the duration of the study. - 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 - -Unable to discontinue prior to Day 1 any prohibited concomitant monoamine oxidase inhibitors (MAOIs), potent CYP3A4 inducers or inhibitors, potent UGT inducers or inhibitors, including over the counter preparations, herbal remedies, vitamin, mineral supplements, food or drinks as detailed in 11.5.1.2 - Is pregnant or lactating (female subjects only). - Male subject whose partner is pregnant - Has used paracetamol/acetaminophen at a daily dose of equal to or more than 2.5g/day on 5 or more days during 7 consecutive days in the run in phase.- Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.;Secondary Objective: A secondary objective is 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.; Primary end point(s): The primary endpoint that relates to this objective is the change from Baseline (Week 2) to Week 14 in the weekly average of the daily neuropathic pain* score on the 11-point PI-NRS. Subjects will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. *Neuropathic pain will be evaluated in the worse affected leg, as identified at Screening. ; Timepoint(s) of evaluation of this end point: Week 14 last 24-hour period.	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on neuropathic pain in subjects with PLSR.;Secondary Objective: A secondary objective is 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.; Primary end point(s): The primary endpoint that relates to this objective is the change from Baseline (Week 2) to Week 14 in the weekly average of the daily neuropathic pain* score on the 11-point PI-NRS. Subjects will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. *Neuropathic pain will be evaluated in the worse affected leg, as identified at Screening. ; Timepoint(s) of evaluation of this end point: Week 14 last 24-hour period.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Points 1; 2; 6 - Week 14 Point 3 - Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit. Point 4-11 -Change from Baseline (Week 2) to Week 14 ; Secondary end point(s): Efficacy endpoints in neuropathic pain: 1. 50% neuropathic daily pain reduction response (yes/no) at Week 14, where a 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 (yes/no) at Week 14, where a response is defined as a =30% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14? 3. Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit Efficacy endpoint in low back pain: 4. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily pain score for low back pain; subjects will be asked every evening to rate their overall low back pain for the last 24-hour period Other efficacy endpoints: 5. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 14, where a responder is defined as either “much improved” or “very much improved” 6. Change from Baseline (Week 2) to Week 14 on the Oswestry Disability Index 7. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily sleep score; subjects will be asked every morning to rate on the 11-point Sleep Numerical Rating Scale (S-NRS) how leg pain interfered with their sleep quality 8.Cha	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Points 1; 2; 6 - Week 14 Point 3 - Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit. Point 4-11 -Change from Baseline (Week 2) to Week 14 ; Secondary end point(s): Efficacy endpoints in neuropathic pain: 1. 50% neuropathic daily pain reduction response (yes/no) at Week 14, where a 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 (yes/no) at Week 14, where a response is defined as a =30% reduction in the weekly average of the daily neuropathic pain score from Baseline (Week 2) to Week 14? 3. Changes from Baseline (Week 2) in the weekly average of the daily neuropathic pain score at each visit Efficacy endpoint in low back pain: 4. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily pain score for low back pain; subjects will be asked every evening to rate their overall low back pain for the last 24-hour period Other efficacy endpoints: 5. Patient Global Impression of Change (PGIC) responder (yes/no) at Week 14, where a responder is defined as either “much improved” or “very much improved” 6. Change from Baseline (Week 2) to Week 14 on the Oswestry Disability Index 7. Change from Baseline (Week 2) to Week 14 in the weekly average of the daily sleep score; subjects will be asked every morning to rate on the 11-point Sleep Numerical Rating Scale (S-NRS) how leg pain interfered with their sleep quality 8.Cha

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Countries

Austria, Belgium, Bulgaria, Czech Republic, France, Georgia, Italy, Latvia, Lithuania, Netherlands, Romania, Serbia, Slovakia, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026