Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial

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 supporti ve 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.DiscussionWe 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 registrationClinicalTrials.gov,NCT03777956. Registered on 18 December 2018.
Source: Trials - Category: Research Source Type: clinical trials

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ConclusionsA history of MST is common among older women veterans and associated with a range of medical and mental health diagnoses. These findings call attention to the need for additional research in this understudied population, and the importance of trauma-informed care approaches for women across the lifespan.
Source: Journal of General Internal Medicine - Category: Internal Medicine Source Type: research
Rebound headaches, also known as medication overuse headaches, are caused by the frequent or excessive use of pain-relieving and/or antimigraine drugs to treat headache attacks that are already in progress. (Note that these are not the same as oral prophylactic or preventive medicines, which should be taken daily.) In other words, the same medications that initially relieve headache pain can themselves trigger subsequent headaches if they are used too often. Medication overuse headaches can be disabling, forcing people with this condition to take sick leave and to be less productive at work and home. To be diagnosed with m...
Source: Harvard Health Blog - Category: Consumer Health News Authors: Tags: Drugs and Supplements Headache Health Source Type: blogs
This study identified factors associated with suicidal ideation (SI) among a rarely studied subgroup of Veterans: those with cancer.Methods: Veterans (age M = 61.83) with cancer (N= 175) referred for psychological evaluation completed measures of pain, sleep, depressive, anxiety, and PTSD symptoms. SI was defined by endorsing on paper-and-pencil questionnaire thoughts of killing oneself in the past 2 weeks or during clinical interview.Results: 25.1% reported SI. Compared to those without SI, Veterans with SI had higher ratings on measures of depression, anxiety, and PTSD symptoms. History of suicide attempt(s) was included...
Source: Clinical Gerontologist - Category: Geriatrics Tags: Clin Gerontol Source Type: research
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Source: Multidisciplinary Respiratory Medicine - Category: Respiratory Medicine Source Type: research
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Source: Chronobiology International - Category: Biology Authors: Tags: Chronobiol Int Source Type: research
The objective of this cross sectional study was to assess knowledge and attitudes in medical students regarding burn complications. A 12-question survey was distributed among 3rd, 4th and 5th year students of public sector medical colleges of Karachi, Pakistan. Out of 353 respondents, the proportion of students that were aware of burn complications was the following, with an expected response of 100% for each complication: depression [86%], fear [53.3%], post-traumatic stress disorder [40.8%], suicidal tendencies [35.1%], sleep disorder [30%], anxiety [27%], guilt [12.7%], personality changes [7%], eating disorder [5.4%], ...
Source: Burns - Category: Dermatology Source Type: research
Conclusions In a cohort of women undergoing surgery for POP, pelvic floor symptom severity is associated with health-related quality of life domains measured by the PROMIS-57.
Source: Female Pelvic Medicine and Reconstructive Surgery - Category: OBGYN Tags: Original Articles Source Type: research
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Source: Cliffside Malibu - Category: Addiction Authors: Tags: Addiction Recovery Drug Treatment Painkiller Substance Abuse painkillers prescription drug abuse prescription drug addiction prescription drug detox prescription drug use prescription drugs prescription medication prescription pills Source Type: blogs
Abstract Infant and maternal mortality rates are among the highest in the world in low and middle-income countries where postpartum depression impacts at least one in five women. Currently, there is a dearth of data on maternal mood and infant health outcomes in small-scale non-industrial populations from such countries, particularly during the postnatal period. Here, we present the first investigation of postpartum maternal mood among a foraging population, the Hadza of Tanzania. We administered the Edinburgh Postnatal Depression Scale (EPDS) to twenty-three women, all with infants under the age of 12 months...
Source: Culture, Medicine and Psychiatry - Category: Psychiatry Authors: Tags: Cult Med Psychiatry Source Type: research
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Source: Psychological Medicine - Category: Psychiatry Authors: Tags: Psychol Med Source Type: research
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