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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR LACOSAMIDE

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Clinical Trials for Lacosamide

Trial ID Title Status Sponsor Phase Summary
NCT00135109 Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy Completed UCB Pharma Phase 3 This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the start of treatment. To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.
NCT00136019 SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization Completed UCB Pharma Phase 3 Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in a research study at approximately 85 different locations in the United States. The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of a study drug (lacosamide [SPM 927]) taken orally twice a day for about five months. Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide up to the target dose of 400mg/day or 600mg/day. The target dose or placebo will be maintained for 12 weeks. The study clinic visits will include a medical history and physical exam, electrocardiogram (ECG), blood and urine sample collection, and completion of a seizure diary. Patients who complete the study may enroll in an extension trial and receive active study drug.
NCT00220337 A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy Completed UCB Pharma Phase 3 The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain. Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available. If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.
NCT00220415 A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generaliza Completed UCB Pharma Phase 3 Male and female patients between 16 and 70 years of age who are diagnosed with epilepsy with partial seizures and are taking up to 3 medications for this medical condition will take part in this research study at approximately 80 different locations in Australia and Europe. The purpose of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of study drug (lacosamide) taken orally twice a day for about 4 months. Each patient who qualifies and chooses to participate in the study will receive placebo (inactive drug) or gradually increasing doses of lacosamide (SPM 927) up to the target dose of 200mg/day or 400mg/day. The target dose or placebo will be maintained for 12 weeks. The study clinic visits will include a medical history and physical exam, ECG, blood and urine sample collection, and completion of a seizure diary. Patients who complete the study may enroll in an extension trial and receive active study drug.
NCT00235443 A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy Completed UCB Pharma Phase 2/Phase 3 Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
NCT00235469 A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy Completed UCB Pharma Phase 2/Phase 3 This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment. To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.
NCT00237458 An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain Completed UCB Pharma Phase 2 This trial is the follow-on trial to a preceeding open-label trial which included patients with chronic refractory neuropathic pain. It is conducted at one site in the United Kingdom and the patient enrollment is completed. The patients had successfully completed the above mentioned trial and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Different pain qualities are assessed by a patient's diary.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lacosamide

Condition Name

Condition Name for Lacosamide
Intervention Trials
Epilepsy 33
Partial Epilepsies 6
Painful Diabetic Neuropathy 4
Partial-onset Seizures 3
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Condition MeSH

Condition MeSH for Lacosamide
Intervention Trials
Epilepsy 39
Seizures 32
Epilepsies, Partial 15
Diabetic Neuropathies 8
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Clinical Trial Locations for Lacosamide

Trials by Country

Trials by Country for Lacosamide
Location Trials
United States 448
Germany 29
Australia 26
France 16
Poland 16
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Trials by US State

Trials by US State for Lacosamide
Location Trials
Texas 25
Ohio 22
North Carolina 21
Florida 19
Maryland 18
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Clinical Trial Progress for Lacosamide

Clinical Trial Phase

Clinical Trial Phase for Lacosamide
Clinical Trial Phase Trials
Phase 4 10
Phase 3 32
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Lacosamide
Clinical Trial Phase Trials
Completed 51
Recruiting 10
Active, not recruiting 8
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Clinical Trial Sponsors for Lacosamide

Sponsor Name

Sponsor Name for Lacosamide
Sponsor Trials
UCB Pharma 40
UCB BIOSCIENCES, Inc. 11
UCB Japan Co. Ltd. 4
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Sponsor Type

Sponsor Type for Lacosamide
Sponsor Trials
Industry 78
Other 30
NIH 1
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