The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.
The study consists of two treatment periods of 22 days with randomized CNV1014802 350mg or placebo administered twice daily. In addition, single blind placebo will be administered during a two week run-in, a two week wash-out period between the two treatment periods, and a one week run-out phase. This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
Administered as specified in treatment arm.
Administered as specified in treatment arm
Research Site
Brno, Czechia
Research Site
Litoměřice, Czechia
Research Site
Prachatice, Czechia
Research Site
Glostrup Municipality, Denmark
Change in Average Daily Neuropathic Pain Score from Baseline
Change in average daily neuropathic pain score from baseline (average days 10-14) to week 3 based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable). Subjects should specifically rate the pain intensity for the neuropathic pain associated with lumbosacral radiculopathy and not pain from other concomitant causes
Time frame: Three weeks
Numerical Pain Rating Scale
Change in average daily pain score from baseline (average days 10-14) to week 1 and week 2 of treatment and 1 week following the end of randomized treatment.
Time frame: 3 weeks
Responder Rate
Proportion of patients who have \>= 30% and \>=50% reduction in average daily pain score relative to baseline during weeks 1, 2 and 3 of treatment and 1 week following the end of randomized treatment.
Time frame: 3 weeks
Galer Neuropathic Pain Scale
Change in Galer Neuropathic Pain Scale from baseline to week 3 of treatment.
Time frame: 3 weeks
Oswestry Disability Index
Change in average disability score from baseline to week 1, week 2 and week 3 of treatment based on Oswestry Disability Index
Time frame: 3 weeks
PGIC
Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Patient Global Impression of Change (PGIC) on week 3 of treatment.
Time frame: 3 weeks
CGIC
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Research Site
Odense, Denmark
Research Site
Lille, France
Research Site
Nice, France
Research Site
Paris, France
Research Site
Saint-Etienne, France
Research Site
Gothenburg, Sweden
...and 2 more locations
Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Clinical Global Impression of Change (CGIC) on week 3 of treatment.
Time frame: 3 weeks