Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074

NCT02957617 | Terminated Phase 2 DMC

• 2 other identifiers: 1014802-2042015-004796-68
• Study Type: interventional
• Target: 302
• Locations: 13 countries
• Sites: 50

Brief Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).

Conditions

Neuropathic Pain From Lumbosacral Radiculopathy

Keywords

Neuropathic Pain From Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

• Number of Participants experiencing Adverse Events(AE) and Serious Adverse Events (SAEs)

  Safety surveillance

  Up to 395 Days

Secondary Outcomes (12)

• Change from Baseline to Week 52 in the weekly average of the daily neuropathic pain score on the Pain Intensity Numerical Rating Scale (PI-NRS)

  Baseline to Week 52

• 50% neuropathic pain reduction response

  At Week 52

• 30% neuropathic pain reduction response

  At Week 52

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

  Baseline through Week 52

• Change from Baseline to Week 52 in the weekly average of the daily pain score for low back pain

  Baseline to Week 52

Study Arms (1)

BIIB074

EXPERIMENTAL

BIIB074 orally twice daily

Drug: BIIB074

Interventions

BIIB074 DRUG

Participants will receive an initial dose regimen of 350mg orally twice daily (BID), which may be reduced to 200mg based on tolerability for up to 12 months.

Also known as: CNV1014802

BIIB074

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 completed Study 1014802-203 for its complete duration.

You may not qualify if:

• Had a treatment-related AE or SAE that would pose an increased risk for continued treatment with BIIB074, or discontinued study treatment in the double-blind Phase 2b study (Study 1014802-203) due to an AE or SAE.
• Did not return for all study visits after discontinuing treatment in the double-blind phase of the Phase 2b study.

Sponsors & Collaborators

• Biogen: lead

Study Sites (51)

Research Site

Klagenfurt, 9020, Austria

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Leuven, 3212, Belgium

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Blagoevgrad, 2700, Bulgaria

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Rousse, 7003, Bulgaria

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Sofia, 1000, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1784, Bulgaria

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Sofia, 4001, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Beroun, 26601, Czechia

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Choceň, 56501, Czechia

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Litoměřice, 41201, Czechia

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Litomyšl, 57001, Czechia

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Ostrava, 70200, Czechia

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Prachatice, 38301, Czechia

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Prague, 10000, Czechia

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Prague, 14000, Czechia

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Prague, 16000, Czechia

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Prague, 179012, Czechia

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Zlín, 76001, Czechia

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Tartu, 51014, Estonia

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Paris, 75014, France

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Tbilisi, 0144, Georgia

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Tbilisi, 0160, Georgia

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Tbilisi, 0179, Georgia

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Tbilisi, 0186, Georgia

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Rome, 00161, Italy

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Liepāja, LV-3414, Latvia

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Riga, LV-1002, Latvia

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Riga, LV-1003, Latvia

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Bucharest, 010584, Romania

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Cluj-Napoca, 400437, Romania

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Craiova, 200642, Romania

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Belgrade, 11000, Serbia

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Belgrade, 11000, Serbia

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Belgrade, 21000, Serbia

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Banská Bystrica, 974 04, Slovakia

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Dubnica nad Váhom, 018 41, Slovakia

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Krompachy, 053 42, Slovakia

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Pruské, 01852, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Barcelona, 08907, Spain

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Granada, 18014, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Madrid, 28690, Spain

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Madrid, 28938, Spain

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Edinburgh, EH4 2XU, United Kingdom

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Liverpool, L9 7LI, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE1 7EH, United Kingdom

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MeSH Terms

Interventions

vixotrigine

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: November 8, 2016
• Study Start: February 10, 2017
• Primary Completion: February 7, 2019
• Study Completion: February 7, 2019
• Last Updated: February 25, 2019

Record last verified: 2019-02

Locations

GE (4); FR (1); RO (3); AU (1); SL (5); GB (4); BU (7); CZ (11); ES (6); IT (1); LA (3); SE (3); BE (1)