Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial
Abstract Background Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide is a sodium-channel blocker that is efficacious in animal models of neu...
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| Format: | Article |
| Language: | English |
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BMC
2019-10-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3695-7 |
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| author | Malin E. Carmland Melissa Kreutzfeldt Jakob V. Holbech Niels T. Andersen Troels S. Jensen Flemming W. Bach Søren H. Sindrup Nanna B. Finnerup |
| author_facet | Malin E. Carmland Melissa Kreutzfeldt Jakob V. Holbech Niels T. Andersen Troels S. Jensen Flemming W. Bach Søren H. Sindrup Nanna B. Finnerup |
| author_sort | Malin E. Carmland |
| collection | DOAJ |
| description | Abstract Background Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide is a sodium-channel blocker that is efficacious in animal models of neuropathic pain. In humans, its effect in neuropathic pain is inconclusive, based on inconsistent results and very large placebo responses. Previous trials have not used patient stratification or looked for predictors for response. Methods This study will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel, phase 2, proof-of-concept, phenotype-stratified study. The study will enroll 108 patients with peripheral neuropathic pain who will be randomized to a 12-week treatment with lacosamide or placebo up to 400 mg/day in a 2:1 ratio. The primary objective is to compare the change in the mean value of the patients’ daily ratings of average pain intensity from baseline to the last week of treatment in patients with and without the irritable nociceptor phenotype in the per-protocol population. A supportive objective is to compare the effect of lacosamide with that of placebo in the two phenotypes. Secondary and tertiary outcomes include the Patient Global Impression of Change, pain relief, presence of 30% and 50% pain reduction, sleep disturbance, depression, and anxiety. Discussion We will examine the concept of individualized therapy based on phenotyping, and expect that this study will provide important information on the usefulness of lacosamide in the treatment of peripheral neuropathic pain. Trial registration ClinicalTrials.gov, NCT03777956. Registered on 18 December 2018. |
| first_indexed | 2024-12-13T06:23:36Z |
| format | Article |
| id | doaj.art-bddc6160b8e64eacbc4c0459def21e1b |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T06:23:36Z |
| publishDate | 2019-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-bddc6160b8e64eacbc4c0459def21e1b2022-12-21T23:56:47ZengBMCTrials1745-62152019-10-012011810.1186/s13063-019-3695-7Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trialMalin E. Carmland0Melissa Kreutzfeldt1Jakob V. Holbech2Niels T. Andersen3Troels S. Jensen4Flemming W. Bach5Søren H. Sindrup6Nanna B. Finnerup7Danish Pain Research Center, Department of Clinical Medicine, Aarhus UniversityDepartment of Neurology, Odense University HospitalDepartment of Neurology, Odense University HospitalDepartment of Public Health, Aarhus UniversityDanish Pain Research Center, Department of Clinical Medicine, Aarhus UniversityDepartment of Neurology, Aarhus University HospitalDepartment of Neurology, Odense University HospitalDanish Pain Research Center, Department of Clinical Medicine, Aarhus UniversityAbstract Background Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide is a sodium-channel blocker that is efficacious in animal models of neuropathic pain. In humans, its effect in neuropathic pain is inconclusive, based on inconsistent results and very large placebo responses. Previous trials have not used patient stratification or looked for predictors for response. Methods This study will be conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel, phase 2, proof-of-concept, phenotype-stratified study. The study will enroll 108 patients with peripheral neuropathic pain who will be randomized to a 12-week treatment with lacosamide or placebo up to 400 mg/day in a 2:1 ratio. The primary objective is to compare the change in the mean value of the patients’ daily ratings of average pain intensity from baseline to the last week of treatment in patients with and without the irritable nociceptor phenotype in the per-protocol population. A supportive objective is to compare the effect of lacosamide with that of placebo in the two phenotypes. Secondary and tertiary outcomes include the Patient Global Impression of Change, pain relief, presence of 30% and 50% pain reduction, sleep disturbance, depression, and anxiety. Discussion We will examine the concept of individualized therapy based on phenotyping, and expect that this study will provide important information on the usefulness of lacosamide in the treatment of peripheral neuropathic pain. Trial registration ClinicalTrials.gov, NCT03777956. Registered on 18 December 2018.http://link.springer.com/article/10.1186/s13063-019-3695-7Neuropathic painPrecision medicineLacosamideRandomized controlled trial |
| spellingShingle | Malin E. Carmland Melissa Kreutzfeldt Jakob V. Holbech Niels T. Andersen Troels S. Jensen Flemming W. Bach Søren H. Sindrup Nanna B. Finnerup Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial Trials Neuropathic pain Precision medicine Lacosamide Randomized controlled trial |
| title | Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial |
| title_full | Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial |
| title_fullStr | Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial |
| title_full_unstemmed | Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial |
| title_short | Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial |
| title_sort | effect of lacosamide in peripheral neuropathic pain study protocol for a randomized placebo controlled phenotype stratified trial |
| topic | Neuropathic pain Precision medicine Lacosamide Randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-019-3695-7 |
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