Study to Evaluate the Efficacy and Safety of BIIB074 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
- Conditions
- europathic Pain From Lumbosacral RadiculopathyMedDRA version: 19.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disordersMedDRA version: 19.0 Level: PT Classification code 10050219 Term: Lumbar radiculopathy System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-004775-78-NL
- Lead Sponsor
- Convergence Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 424
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.
d. Pain in the legs must be more severe than pain in the back and must be asymmetrical.
6. Has computed tomography (CT) or magnetic resonance imaging (MRI) available that does not show evidence of exclusionary pathology (see exclusion criteria); if not available or has not been conducted within 12 months prior to Screening, MRI must be conducted at Screening. CT is acceptable for subjects with contra-indications for MRI (e.g. metallic implants).
7. Has duration of neuropathic (leg) pain of at least 6 months before Screening.
8. Has stable intensity of neuropathic (leg) pain, with fairly continual pain (but may be worse during rest or at night) for the 4 weeks prior to Screening, based on clinical history.
9. 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
10. If taking approved concomitant pain medications (i.e., NSAIDs), must be on a stable regimen for at least 4 weeks before Day 1.
Inclusion Criteria: Randomization
To be eligible to be randomized in this study, candidates must meet the following eligibility criteria at the Randomization Visit (Day 15, Week 2):
1. Continues to meet inclusion criteria (above).
2. Has a baseline weekly average daily pain score for neuropathic pain (leg pain) due to PLSR =4 and =9 on the electronic diary PI-NRS; baseline is defined as the 7 days prior to randomization (nominal Days 8 to 14, with randomization on Day 15).
3. Completed washout of concomitant pain medications excep
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 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.;<br> 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.<br> *Neuropathic pain will be evaluated in the worse affected leg, as identified at Screening.<br> ;<br> Timepoint(s) of evaluation of this end point: Week 14 last 24-hour period.<br>
- Secondary Outcome Measures
Name Time Method