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Lacosamid Medical Research Studies

Up-to-date List of Lacosamid Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Lacosamid Medical Research Studies

Rank Status Study
1 Recruiting Cognitive and Behavioral Effects of Lacosamide
Condition: Epilepsy
Intervention: Drug: Lacosamide
Outcome Measures: Changes in Cognitive test scores;   Relationship of Cognitive test scores with Seizure severity ,A-B Neurotoxicity,Adverse Events and Lacosamide Dosage
2 Recruiting Lacosamide for Seizure Prophylaxis in High-Grade Gliomas
Condition: Brain Cancer
Interventions: Drug: Lacosamide;   Other: Placebo
Outcome Measure: Time to First Seizure (TFS)
3 Recruiting Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
Conditions: Epilepsy;   Partial-onset Seizures
Intervention: Drug: Lacosamide
Outcome Measures: Adverse Events (AEs) reported spontaneously by the subject or observed by the investigator from Baseline until the End of Study Visit;   Subject withdrawals due to Adverse Events from Baseline until the End of Study Visit;   Percent change in Partial-onset Seizure frequency per 28 days from Baseline until the End of Study Visit;   50 % response rate from Baseline of study EP0008 [NCT01710657] until the End of Study Visit
4 Not yet recruiting Safety and Tolerability of Lacosamide in Patients With Gain-of-function Nav1.7 Mutations Related Small Fiber Neuropathy
Condition: Small Fiber Neuropathy
Interventions: Drug: Lacosamide;   Drug: Placebo
Outcome Measures: Pain Intensity Numerical Rating Scale;   Daily Sleep Interference Scale;   • Adverse Events, Laboratory Safety Tests (Hematology, Clinical Chemistry, Urinalysis), Blood Pressure, Pulse Rate, ECG.;   Small Fiber Neuropathy Symptoms Inventory Questionnaire (SFN-SIQ).;   Patient Global Impression of Change (PGIC).;   Neuropathic Pain Scale (NPS).
5 Recruiting Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Conditions: Epilepsy;   Monotherapy
Interventions: Drug: Lacosamide;   Drug: Carbamazepine-Controlled Release (CBZ-CR)
Outcome Measures: Number of subjects with at least one treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum of 3.5 Years);   Number of subjects who withdrew from the study due to a treatment-emergent Adverse Event (AE) during the Treatment Phase (Maximum 3.5 Years);   Number of subjects with at least one treatment- emergent Serious Adverse Event (SAE) during the Treatment Phase (Maximum of 3.5 years)
6 Recruiting Lacosamide IV and EEG/EKG (LIVE) Study
Condition: Focal Epilepsy
Intervention: Drug: Lacosamide
Outcome Measures: Change in the number of interictal spikes;   Change in frequency and quantity of background EEG rhythms;   Change in EKG (QT, PR interval and heart rhythm)
7 Recruiting A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures
Conditions: Epilepsy;   Partial-onset Seizures
Intervention: Drug: Lacosamide
Outcome Measures: Incidence of Treatment-Emergent Adverse Events (TEAEs) during the study;   Subject withdrawals due to Adverse Events (AEs) during the study;   Serious Adverse Events (SAEs) during the study;   Proportion of subjects remaining seizure free for 6 consecutive months during the Monotherapy Period;   Proportion of subjects remaining seizure free for 12 consecutive months during the Monotherapy Period;   Time to discontinuation is evaluated as time to withdrawal of treatment due to AE or lack of efficacy (LOE) in the Monotherapy Period
8 Recruiting A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.
Condition: Epilepsy
Intervention: Drug: Lacosamide
Outcome Measures: Changes in count of generalized spike-wave discharges on 24-hour ambulatory electroencephalogram (EEG) from Visit 2 to Visit 6;   Change in days with any generalized seizures (absence, myoclonic, clonic, tonic, tonic-clonic, atonic, partial evolving to secondarily generalized) per 28 days from the Baseline Period to the Maintenance Period (approximately 24 weeks);   Changes in count of 3Hz spike-wave discharges (during waking hours) on 24-hour ambulatory EEG from Visit 2 to Visit 6;   Number of subject withdrawals due to Adverse Events from baseline to end of study (approximately 32 weeks);   Number of subjects experiencing at least 1 Treatment-emergent Adverse event from baseline to end of study (approximately 32 weeks)
9 Recruiting A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
Condition: Epilepsy
Intervention: Drug: Lacosamide
Outcome Measures: Number of subjects that report at least one Treatment-emergent Adverse Event during the study (approximately 13 weeks);   Mean LCM plasma concentration at Visit 5 (Day 27/28) or Early Termination;   Mean SPM 12809 plasma concentration at Visit 5 (Day 27/28) or Early Termination;   Change in seizure frequency from Baseline to End of Treatment;   Mean Caregiver Global Impression of Change score at Visit 5 (Day 27/28) or Early Termination;   Mean in Clinical Global Impression of Change score at Visit 5 (Day 27/28) or Early Termination
10 Recruiting Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
Condition: Epilepsy
Interventions: Drug: Lacosamide;   Other: Placebo
Outcome Measures: Change in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period;   Proportion of responders, ≥ 50% reduction in partial onset seizure frequency from Baseline to the Maintenance Period;   Proportion of subjects experiencing a ≥25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency from Baseline to the end of Maintenance Period;   Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods);   Proportion of subjects experiencing a ≥25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency from Baseline to the entire treatment (ie, Titration+Maintenance Periods);   Proportion of subjects experiencing no change in partial onset seizure frequency (between <25 % reduction and <25 % increase) from Baseline to the entire treatment (ie, Titration+Maintenance Periods);   Proportion of subjects experiencing an increase in partial onset seizure frequency of ≥25 % from Baseline to the entire treatment (ie, Titration+Maintenance Periods);   Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) by seizure type;   Proportion of seizure free days during the Maintenance Period for subjects who completed the Maintenance Period;   Proportion of subjects who achieved "seizure free" status (yes/no) for subjects who completed the Maintenance Period
11 Recruiting Add on Lacosamide Versus High Dose Monotherapy
Condition: Epilepsy
Intervention: Drug: Lacosamide, levetiracetam
Outcome Measures: Percentage of patients achieving six month seizure freedom;   Number of seizure-free months;   Time to seizure after therapeutic dose is reached;   Retention rate;   Number of reported side effects
12 Recruiting Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
Condition: Focal Epilepsy With and Without Secondary Generalization
Intervention:
Outcome Measure: The percent change in ratio of dose and Defined Daily Dose (DDD) for the drug load of concomitant Anti-Epileptic Drugs (AEDs) from Baseline to the end of Observation Period (Day 0 to 6 months)
13 Recruiting Randomized Controlled Trial to Assess Effects of Lacosamide on Sleep and Wake in Adults With Focal Epilepsy
Condition: Partial Epilepsy
Interventions: Drug: Lacosamide;   Drug: Placebo
Outcome Measures: Change in Epworth Sleepiness Scale score from Baseline to Visit 4;   Change in mean sleep latency on the maintenance of wakefulness test from Baseline to Visit 4.
14 Recruiting Intravenous Lacosamide Compared With Fosphenytoin in the Treatment of Patients With Frequent Nonconvulsive Seizures
Condition: Nonconvulsive Seizures
Interventions: Drug: Lacosamide - 'Crossover';   Drug: Fosphenytoin - 'crossover'
Outcome Measures: Percentage of subjects who experience no NCSs for 24 hours following treatment with LCM vs. fPHT, as measured by continuous electroencephalography (cEEG) monitoring.;   Percentage of subjects who require a rebolus of the initial antiepileptic drug (AED) to control NCSs in the LCM vs fPHT arms.;   Percentage of subjects who require a second AED to control NCSs.;   Percent change in seizure time (defined as the number of minutes of electrographic seizure (ESz) activity per hour) before treatment and at the end of the first treatment arm.;   Percent change in seizure time (defined as the number of minutes of ESz activity per hour) before treatment and at the end of the second treatment arm.;   Time from bolus to time of the end of the last seizure for both first (initial bolus/rebolus)and second (crossover bolus/rebolus) treatment arms.;   Frequency of predefined adverse events (AEs) in the LCM vs fPHT arms.;   Percentage of subjects in whom study drug is withdrawn early;   Days in the intensive care unit/hospital from start of treatment in the LCM vs fPHT arms.;   Functional status as measured by the Functional Disability Scale at Day 7 to 9 postrandomization and Day 30 post-randomization in the LCM vs fPHT arms.;   Percentage of all subjects who have had a seizure, are on AED therapy, and are alive/dead at the 6-, 12-, and 24-month post-randomization follow-ups.
15 Unknown  Lacosamid-i.v.-Register
Condition: Epilepsy With Partial Onset Seizures With or Without Secondary Generalization
Intervention: Drug: Lacosamide 10mg/ml
Outcome Measure:
16 Unknown  Effects of Adjunctive Lacosamide on Mood States and Quality of Life (QOL) in Patients With Epilepsy
Condition: Epilepsy
Intervention:
Outcome Measures: Change from baseline in overall QOLIE-89 score;   Change from baseline in Profile of Mood States (POMS) score;   Change from baseline in QOLIE-89 subtests;   Change from baseline in POMS subtests
17 Recruiting A Pharmacogenomic Exploration of Lacosamide Response
Condition: Epilepsy
Intervention:
Outcome Measures: Seizure frequency;   Maintenance dose;   Adverse drug reactions

These studies may lead to new treatments and are adding insight into Lacosamid etiology and treatment.

A major focus of Lacosamid research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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