Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy
NCT ID: NCT02935608
Last Updated: 2018-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
502 participants
INTERVENTIONAL
2016-10-31
2018-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BIIB074 high dose
Administered twice daily (BID)
BIIB074
Administered as specified in the treatment arm
BIIB074 low dose
Administered BID
BIIB074
Administered as specified in the treatment arm
Placebo
Placebo administered BID
Placebo
Matched placebo
Interventions
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BIIB074
Administered as specified in the treatment arm
Placebo
Matched placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Klagenfurt, , Austria
Research Site
Leuven, , Belgium
Research Site
Blagoevgrad, , Bulgaria
Research Site
Rousse, , Bulgaria
Research Site
Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
Research Site
Veliko Tarnovo, , Bulgaria
Research Site
Beroun, , Czechia
Research Site
Choceň, , Czechia
Research Site
Litoměřice, , Czechia
Research Site
Litomyšl, , Czechia
Research Site
Ostrava, , Czechia
Research Site
Prachatice, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Prague, , Czechia
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Zlín, , Czechia
Research Site
Paris, , France
Research Site
Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
Research Site
Milan, , Italy
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Rome, , Italy
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Liepāja, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Nieuwegein, , Netherlands
Research Site
Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
Research Site
Craiova, , Romania
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Belgrade, , Serbia
Research Site
Belgrade, , Serbia
Research Site
Banská Bystrica, , Slovakia
Research Site
Dolný Kubín, , Slovakia
Reasearch Site
Dubnica nad Váhom, , Slovakia
Research Site
Krompachy, , Slovakia
Research Site
Pruské, , Slovakia
Research Site
Spišská Nová Ves, , Slovakia
Research Site
Barcelona, , Spain
Research Site
Elche, , Spain
Research Site
Granada, , Spain
Research Site
Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
Research Site
Birmingham, , United Kingdom
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Edinburgh, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Other Identifiers
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2015-004775-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1014802-203
Identifier Type: -
Identifier Source: org_study_id
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