Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
|ClinicalTrials.gov Identifier: NCT01561027|
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : October 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lumbosacral Radiculopathy||Drug: CNV1014802 Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy|
|Actual Study Start Date :||April 30, 2011|
|Primary Completion Date :||June 30, 2012|
|Study Completion Date :||August 31, 2012|
CNV1014802 350mg on prescription (BID) for 21 days
Administered as specified in treatment arm.
Placebo Comparator: Placebo
Placebo 350mg BID for 21 days
Administered as specified in treatment arm
- Change in Average Daily Neuropathic Pain Score from Baseline [ Time Frame: Three weeks ]
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
- Numerical Pain Rating Scale [ Time Frame: 3 weeks ]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.
- Responder Rate [ Time Frame: 3 weeks ]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.
- Galer Neuropathic Pain Scale [ Time Frame: 3 weeks ]Change in Galer Neuropathic Pain Scale from baseline to week 3 of treatment.
- Oswestry Disability Index [ Time Frame: 3 weeks ]Change in average disability score from baseline to week 1, week 2 and week 3 of treatment based on Oswestry Disability Index
- PGIC [ Time Frame: 3 weeks ]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.
- CGIC [ Time Frame: 3 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01561027
|Study Director:||Medical Director||Biogen|