11/11/2016 A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 40,
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`Trial record 11 of 12 for: Vimpat | Studies received from 01/01/2000 to 01/01/2007
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`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 Generalization
`
`This study has been completed.
`
`Sponsor:
`UCB Pharma
`
`Information provided by:
`UCB Pharma
`
`ClinicalTrials.gov Identifier:
`NCT00220415
`
`First received: August 30, 2005
`Last updated: September 19, 2014
`Last verified: February 2010
`History of Changes
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`No Study Results Posted
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`Disclaimer
`
`How to Read a Study Record
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` Purpose
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`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.
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`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.
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`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.
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`Patients who complete the study may enroll in an extension trial and receive active study drug.
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`Condition
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`Intervention
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`Phase
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`Partial Seizures With or Without Secondary Generalization
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`Drug: SPM 927
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`Phase 3
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`Interventional
`Study Type:
`Study Design: Allocation: Randomized
`Intervention Model: Parallel Assignment
`Masking: Double-Blind
`Primary Purpose: Treatment
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`Official Title:
`
`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
`Generalization
`
`Resource links provided by NLM:
`
`MedlinePlus related topics: Seizures
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`U.S. FDA Resources
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`Further study details as provided by UCB Pharma:
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`Study Start Date:
`Study Completion Date:
`Primary Completion Date:
`
`May 2004
`January 2006
`January 2006 (Final data collection date for primary outcome measure)
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`https://www.clinicaltrials.gov/ct2/show/NCT00220415?term=Vimpat&rcv_s=01%2F01%2F2000&rcv_e=01%2F01%2F2007&rank=11
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`ARGENTUM Exhibit 1185
`Argentum Pharmaceuticals LLC v. Research Corporation Technologies, Inc.
`IPR2016-00204
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`

`
`11/11/2016 A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 40,
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` Eligibility
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`16 Years to 70 Years (Child, Adult, Senior)
`Ages Eligible for Study:
`Both
`Genders Eligible for Study:
`Accepts Healthy Volunteers: No
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`Criteria
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`Inclusion Criteria:
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`partial seizures with or without secondary generalization
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`Exclusion Criteria:
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`subjects received SPM 927 in a previous trial
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` Contacts and Locations
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`Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a
`study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general
`information, see Learn About Clinical Studies.
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00220415
`
`Locations
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`Germany
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`Schwarz
`Monheim, Germany
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`Sponsors and Collaborators
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`UCB Pharma
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`Investigators
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`Study Director: UCB Clinical Trial Call Center UCB Pharma
`
` More Information
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`Additional Information:
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`Clinical Study Summary on UCB.com
`
`Publications:
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`Halász P, Kälviäinen R, Mazurkiewicz-Beldzińska M, Rosenow F, Doty P, Hebert D, Sullivan T; SP755 Study Group.. Adjunctive lacosamide for
`partial-onset seizures: Efficacy and safety results from a randomized controlled trial. Epilepsia. 2009 Mar;50(3):443-53. doi: 10.1111/j.1528-
`1167.2008.01951.x.
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`Sake JK, Hebert D, Isojärvi J, Doty P, De Backer M, Davies K, Eggert-Formella A, Zackheim J. A pooled analysis of lacosamide clinical trial data
`grouped by mechanism of action of concomitant antiepileptic drugs. CNS Drugs. 2010 Dec;24(12):1055-68. doi: 10.2165/11587550-000000000-
`00000.
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`Borghs S, de la Loge C, Cramer JA. Defining minimally important change in QOLIE-31 scores: estimates from three placebo-controlled
`lacosamide trials in patients with partial-onset seizures. Epilepsy Behav. 2012 Mar;23(3):230-4. doi: 10.1016/j.yebeh.2011.12.023.
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`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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`Biton V, Gil-Nagel A, Isojarvi J, Doty P, Hebert D, Fountain NB. Safety and tolerability of lacosamide as adjunctive therapy for adults with partial-
`onset seizures: Analysis of data pooled from three randomized, double-blind, placebo-controlled clinical trials. Epilepsy Behav. 2015 Nov;52(Pt
`A):119-27. doi: 10.1016/j.yebeh.2015.09.006.
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`ClinicalTrials.gov Identifier: NCT00220415 History of Changes
`Other Study ID Numbers:
`SP0755 2004-000290-58
`August 30, 2005
`Study First Received:
`Last Updated:
`September 19, 2014
`Health Authority:
`Germany: Federal Institute for Drugs and Medical Devices
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`Additional relevant MeSH terms:
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`https://www.clinicaltrials.gov/ct2/show/NCT00220415?term=Vimpat&rcv_s=01%2F01%2F2000&rcv_e=01%2F01%2F2007&rank=11
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`11/11/2016 A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 40,
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`Neoplasm Metastasis
`Seizures
`Neoplastic Processes
`Neoplasms
`Pathologic Processes
`Epilepsy
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`ClinicalTrials.gov processed this record on November 10, 2016
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`Brain Diseases
`Central Nervous System Diseases
`Nervous System Diseases
`Neurologic Manifestations
`Signs and Symptoms
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`https://www.clinicaltrials.gov/ct2/show/NCT00220415?term=Vimpat&rcv_s=01%2F01%2F2000&rcv_e=01%2F01%2F2007&rank=11
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