Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy (RELAY-1)

Biogen

Status and phase: Completed; Phase 2

Conditions: Lumbosacral Radiculopathy

Treatments: Drug: Placebo; Drug: BIIB074

Study type: Interventional

Funder types: Industry

Identifiers

NCT02935608

1014802-203

2015-004775-78 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are 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; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.

Full description

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Enrollment: 502 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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
• 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

Key Exclusion Criteria:

• Has planned surgical intervention for PLSR within the duration of the study. (Subjects with persistent radicular pain after prior surgery are eligible.)
• 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

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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502 participants in 3 patient groups, including a placebo group

BIIB074 high dose

Experimental group

Description:

Administered twice daily (BID)

Treatment:

Drug: BIIB074

BIIB074 low dose

Experimental group

Description:

Administered BID

Treatment:

Drug: BIIB074

Placebo

Placebo Comparator group

Description:

Placebo administered BID

Treatment:

Drug: Placebo