Study to Evaluate the Efficacy and Safety ofBIIB074 in Subjects With Neuropathic Pain FromLumbosacral Radiculopathy

Phase 1

• Conditions: europathic PainFrom Lumbosacral Radiculopathy; MedDRA version: 21.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10050219Term: Lumbar radiculopathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004775-78-RO
• Lead Sponsor: Convergence Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-22
• Study Completion: 2018-08-06
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 424

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

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 the 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy of 2 dose regimens of BIIB074 on<br>neuropathic pain in subjects with PLSR.;Secondary Objective: A secondary objective is to evaluate the efficacy of 2 dose regimens of BIIB074 on additional<br>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<br>Week 14 in the weekly average of the daily neuropathic pain* score on the 11-point PI-NRS.<br>Subjects will be asked every evening to rate their overall neuropathic pain for the last 24-hour<br>period.<br>*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<br>period.<br>