Study to Evaluate the Efficacy and Safety ofBIIB074 in Subjects With Neuropathic Pain FromLumbosacral Radiculopathy
- Conditions
- europathic PainFrom Lumbosacral RadiculopathyMedDRA version: 20.0Level: LLTClassification code 10054095Term: Neuropathic painSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10050219Term: Lumbar radiculopathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004775-78-CZ
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 504
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
Key Exclusion Criteria:
- 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
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
- Secondary Outcome Measures
Name Time Method