Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy

NCT02935608 | Completed Phase 2 DMC

• 2 other identifiers: 1014802-2032015-004775-78
• Study Type: interventional
• Target: 502
• Locations: 14 countries
• Sites: 56

Brief Summary

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.

Conditions

Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS)

  Participants will be asked every evening to rate their overall neuropathic pain for the last 24-hour period. PI-NRS is an 11-point pain intensity numerical rating scale (PI-NRS), where 0=no pain and 10=pain as bad as you can imagine.

  Week 14

Secondary Outcomes (19)

• 50% neuropathic daily pain reduction response

  At Week 14

• 30% neuropathic daily pain reduction response

  At Week 14

• Change from Baseline to Week 14 in the weekly average of the daily neuropathic pain score at each visit

  Week 14

• Change from Baseline to Week 14 in weekly average of the daily pain score for low back pain

  Week 14

• Number of Patient Global Impression of Change (PGIC) responders

  At Week 14

Study Arms (3)

BIIB074 high dose

EXPERIMENTAL

Administered twice daily (BID)

Drug: BIIB074

BIIB074 low dose

EXPERIMENTAL

Administered BID

Drug: BIIB074

Placebo

PLACEBO COMPARATOR

Placebo administered BID

Drug: Placebo

Interventions

BIIB074 DRUG

Administered as specified in the treatment arm

Also known as: CNV1014802

BIIB074 high dose; BIIB074 low dose

Placebo DRUG

Matched placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (56)

Research Site

Klagenfurt, 9020, Austria

Location

Research Site

Leuven, 3212, Belgium

Location

Research Site

Blagoevgrad, 2700, Bulgaria

Location

Research Site

Rousse, 7003, Bulgaria

Location

Research Site

Sofia, 1000, Bulgaria

Location

Research Site

Sofia, 1431, Bulgaria

Location

Research Site

Sofia, 1784, Bulgaria

Location

Research Site

Sofia, 4001, Bulgaria

Location

Research Site

Veliko Tarnovo, 5000, Bulgaria

Location

Research Site

Beroun, 26601, Czechia

Location

Research Site

Choceň, 56501, Czechia

Location

Research Site

Litoměřice, 41201, Czechia

Location

Research Site

Litomyšl, 57001, Czechia

Location

Research Site

Ostrava, 70200, Czechia

Location

Research Site

Prachatice, 38301, Czechia

Location

Research Site

Prague, 10000, Czechia

Location

Research Site

Prague, 10034, Czechia

Location

Research Site

Prague, 14000, Czechia

Location

Research Site

Prague, 16000, Czechia

Location

Research Site

Prague, 179012, Czechia

Location

Research Site

Zlín, 76001, Czechia

Location

Research Site

Paris, 75014, France

Location

Research Site

Tbilisi, 0144, Georgia

Location

Research Site

Tbilisi, 0160, Georgia

Location

Research Site

Tbilisi, 0179, Georgia

Location

Research Site

Tbilisi, 0186, Georgia

Location

Research Site

Milan, 20089, Italy

Location

Research Site

Rome, 00161, Italy

Location

Research Site

Liepāja, LV-3414, Latvia

Location

Research Site

Riga, LV-1002, Latvia

Location

Research Site

Riga, LV-1003, Latvia

Location

Research Site

Nieuwegein, 3435 CM, Netherlands

Location

Research Site

Bucharest, 010584, Romania

Location

Research Site

Bucharest, 011171, Romania

Location

Research Site

Cluj-Napoca, 400437, Romania

Location

Research Site

Craiova, 200642, Romania

Location

Research Site

Belgrade, 11000, Serbia

Location

Research Site

Belgrade, 21000, Serbia

Location

Research Site

Banská Bystrica, 974 04, Slovakia

Location

Research Site

Dolný Kubín, 026 01, Slovakia

Location

Reasearch Site

Dubnica nad Váhom, 018 41, Slovakia

Location

Research Site

Krompachy, 053 42, Slovakia

Location

Research Site

Pruské, 01852, Slovakia

Location

Research Site

Spišská Nová Ves, 052 01, Slovakia

Location

Research Site

Barcelona, 08907, Spain

Location

Research Site

Elche, 03293, Spain

Location

Research Site

Granada, 18014, Spain

Location

Research Site

Madrid, 28040, Spain

Location

Research Site

Madrid, 28046, Spain

Location

Research Site

Madrid, 28690, Spain

Location

Research Site

Madrid, 28938, Spain

Location

Research Site

Birmingham, B15 2TH, United Kingdom

Location

Research Site

Edinburgh, EH4 2XU, United Kingdom

Location

Research Site

Liverpool, L9 7LI, United Kingdom

Location

Research Site

London, NW3 2QG, United Kingdom

Location

Research Site

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Interventions

vixotrigine

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 17, 2016
• Study Start: October 31, 2016
• Primary Completion: August 6, 2018
• Study Completion: August 6, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

BU (7); FR (1); GE (4); LA (3); IT (2); SE (2); ES (7); GB (5); RO (4); NL (1); CZ (12); AU (1); SL (6); BE (1)