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

Convergence Pharmaceuticals Ltd0 sites424 target enrollmentJune 1, 2016

Conditionseuropathic Pain From Lumbosacral Radiculopathy MedDRA version: 19.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: PT Classification code 10050219 Term: Lumbar radiculopathy System Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: europathic Pain From Lumbosacral Radiculopathy
Sponsor: Convergence Pharmaceuticals Ltd
Enrollment: 424
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 1, 2016

End Date

August 6, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Convergence Pharmaceuticals Ltd

Eligibility Criteria

Inclusion Criteria

•To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening or at the timepoint specified in the individual eligibility criterion listed:
•1\. Is able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
•2\. Is aged 18 to 75 years, inclusive, at the time of informed consent.
•3\. All women of childbearing potential and all men must practice effective contraception during the study and for 5 weeks for women and 14 weeks for men, after their last dose of study treatment. For further details of contraceptive requirements for this study, please refer to Section 15\.5\.
•4\. Has body weight \=50 kg for men and \=45 kg for women.
•5\. Must have diagnosis of neuropathic PLSR with ALL of the following characteristics:
•a. Pain perceived in 1 or both legs at areas consistent with the area innervated by the L4, L5, or S1 nerve roots.
•b. Evidence of asymmetrical sensory symptoms (hypoesthesia, hyperesthesia, or
•allodynia) in the affected areas (typically, the pain may be perceived in the buttock, thigh, calf, foot, or toes).
•c. History of pain suggestive that the cause of PLSR is due to injury of the lumbosacral nerve root(s) by degenerative disease of the vertebrae in the lumbosacral spine or associated soft tissues including the intervertebral discs, or secondary to spinal injury and not due to infection/abscess, hematoma, or malignancy.

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.