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Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older (SP0993)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
EDEV S.À.R.L
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier:
NCT01243177
First received: November 16, 2010
Last updated: November 13, 2014
Last verified: November 2014
  Purpose

Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).


Condition Intervention Phase
Epilepsy
Monotherapy
Drug: Lacosamide
Drug: Carbamazepine-Controlled Release
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Proportion of subjects remaining seizure free for 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject [ Time Frame: 6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject ] [ Designated as safety issue: No ]
  • Number of subjects with at least one treatment-emergent Adverse Event (AE) during the Treatment Phase (up to 113 weeks) [ Time Frame: Duration of the Treatment Phase (up to 113 weeks) ] [ Designated as safety issue: No ]
  • Number of subjects who withdraw from the study due to a treatment-emergent Adverse Event (AE) during the Treatment Phase (up to 113 weeks) [ Time Frame: Duration of the Treatment Phase (up to 113 weeks) ] [ Designated as safety issue: No ]
  • Number of subjects with at least one treatment- emergent Serious Adverse Event (SAE) during the Treatment Phase (up to 113 weeks) [ Time Frame: Duration of the Treatment Phase (up to 113 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects remaining seizure free for 12 consecutive months (52 consecutive weeks) following stabilization at the last evaluated dose for each subject [ Time Frame: 12 consecutive months of treatment following stabilization at the last evaluated dose for each subject ] [ Designated as safety issue: No ]

Estimated Enrollment: 878
Study Start Date: April 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide Drug: Lacosamide

Lacosamide:

  • Strengths: 50 mg / 100 mg
  • Form: tablets
  • Dosage: 100 mg, 200 mg; 300 mg; 400 mg; 500 mg; 600 mg/ total daily dose, administered twice daily in divided doses
  • Duration: up to 118 weeks
Other Name: Vimpat®
Active Comparator: Carbamazepine-Controlled Release (CBZ-CR) Drug: Carbamazepine-Controlled Release

Carbamazepine-CR:

  • Strengths: 200 mg
  • Form: tablets
  • Dosage: 200 mg; 400 mg; 600 mg; 800 mg; 1000 mg; 1200 mg/ total daily dose, administered twice daily in divided doses
  • Duration: up to 118 weeks
Other Name: Tegretol® Retard Tablets 200 mg

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject able to comply with study requirements
  • Subject is 16 years and older (female; male). Minors will be included in countries only if legally permitted
  • Subject has newly or recently diagnosed Epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the 12 months preceding Visit 1 out of which at least 1 seizure occured 3 months preceding Visit 1
  • Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam of the brain within the past 12 months. If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they need to be completed and results must be available prior to randomization at Visit 2

Exclusion Criteria:

  • Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
  • Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, < 20 minutes) with or without function regained between 2 ictal events
  • Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of Idiopathic Generalized Epilepsy (IGE) at randomization
  • Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures based on expert opinion and/or EEG evidence
  • Subject has any medical or psychiatric condition
  • Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
  • Subject has received treatment with Phenobarbital or Primidone within 28 days prior to Visit 1
  • Subject is taking Benzodiazepines for a nonepilepsy indication
  • Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) (including Benzodiazepines) in the last 6 months before Visit. However, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 3 days prior to randomization
  • Prior use of Felbamate or Vigabatrin is not allowed
  • Benzodiazepines as rescue therapy for Epilepsy may have been used as needed in this time period, but not more frequently than once per week
  • Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
  • Asian ancestry and tests positive for HLA-B*1502 allele
  • Asian ancestry and tests positive for HLA-A*3101 allele
  Contacts and Locations
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: NCT01243177

  Hide Study Locations
Locations
United States, Alabama
786
Alabaster, Alabama, United States
799
Huntsville, Alabama, United States
United States, Arizona
780
Phoenix, Arizona, United States
United States, Arkansas
777
Little Rock, Arkansas, United States
United States, Florida
795
Ocala, Florida, United States
789
Panama City, Florida, United States
776
Port Charlotte, Florida, United States
United States, Kansas
779
Manhattan, Kansas, United States
United States, North Carolina
874
Charlotte, North Carolina, United States
876
Hickory, North Carolina, United States
873
Raleigh, North Carolina, United States
United States, Oklahoma
794
Oklahoma City, Oklahoma, United States
United States, Texas
881
Mansfield, Texas, United States
United States, Wisconsin
790
Madison, Wisconsin, United States
United States, Wyoming
798
Casper, Wyoming, United States
Australia, New South Wales
106
East Gosford, New South Wales, Australia
109
Randwick, New South Wales, Australia
102
Westmead, New South Wales, Australia
Australia, Queensland
103
Herston, Queensland, Australia
Australia, South Australia
100
Woodville, South Australia, Australia
Australia, Victoria
101
Fitzroy, Victoria, Australia
108
Heidelberg, Victoria, Australia
Australia
104
Chatswood, Australia
105
Clayton, Australia
110
Victoria, Australia
Belgium
127
Brugge, Belgium
134
Brugge, Belgium
128
Hasselt, Belgium
126
Leuven, Belgium
Bulgaria
805
Blagoevgrad, Bulgaria
807
Panagyurishte, Bulgaria
803
Pleven, Bulgaria
810
Russe, Bulgaria
806
Sofia, Bulgaria
808
Sofia, Bulgaria
811
Sofia, Bulgaria
809
Veliko Tarnovo, Bulgaria
Canada, Newfoundland and Labrador
153
St John's, Newfoundland and Labrador, Canada
Canada, Quebec
152
Greenfield Park, Quebec, Canada
Canada
155
Calgary, Canada
158
Halifax Nova Scotia, Canada
156
Hamilton, Canada
159
Veilleux, Canada
Czech Republic
185
Brno, Czech Republic
190
Ostrava - Vitkovice, Czech Republic
189
Prague, Czech Republic
184
Praha 5, Czech Republic
180
Zlin, Czech Republic
Finland
205
Helsinki, Finland
207
Kuopio, Finland
France
236
Nancy, France
233
Paris, France
231
Strasbourg, France
235
Toulouse Cedex 9, France
Germany
263
Altenburg, Germany
258
Aschaffenburg, Germany
265
Bad Neustadt, Germany
262
Berlin, Germany
257
Berlin, Germany
270
Berlin, Germany
276
Erlangen, Germany
268
Essen, Germany
260
Göttingen, Germany
274
Kiel, Germany
271
Köln, Germany
269
Leipzig, Germany
256
Marburg, Germany
264
Muenchen, Germany
261
Münster, Germany
259
Osnabruck, Germany
Greece
496
Alexandroupoli, Greece
495
Ioannina, Greece
493
Thessaloniki, Greece
490
Thessalonikis, Greece
Hungary
289
Balassagyarmat, Hungary
283
Budapest, Hungary
284
Budapest, Hungary
286
Debrecen, Hungary
282
Gyor, Hungary
288
Pecs, Hungary
285
Szeged, Hungary
290
Szekszárd, Hungary
291
Szombathely, Hungary
Italy
310
Bari, Italy
313
Cagliari, Italy
309
Modena, Italy
308
Padova, Italy
314
Prato, Italy
311
Roma, Italy
Japan
831
Asaka-shi, Japan
833
Hamamatsu-shi, Japan
834
Kagoshima-shi, Japan
844
Kamakura-shi, Japan
846
Kawasaki-shi, Japan
829
Kokubunji-shi, Japan
843
Miyakonojo, Japan
835
Nagoya-shi, Japan
830
Nara-shi, Japan
837
Okayama-shi, Japan
828
Saitama-shi, Japan
847
Sapporo, Japan
836
Sapporo-shi, Japan
832
Shizuoka-shi, Japan
Korea, Republic of
525
Busan, Korea, Republic of
521
Daegu, Korea, Republic of
518
Dajeon, Korea, Republic of
516
Seoul, Korea, Republic of
517
Seoul, Korea, Republic of
524
Seoul, Korea, Republic of
520
Seoul, Korea, Republic of
523
Seoul, Korea, Republic of
519
Seoul, Korea, Republic of
Latvia
751
Riga, Latvia
Lithuania
727
Alytus, Lithuania
724
Kaunas, Lithuania
728
Vilnius, Lithuania
Mexico
547
San Luis Potosi, Mexico
Philippines
673
Manila, Philippines
672
Pasig City, Philippines
676
Quezon City, Philippines
Poland
336
Gdansk, Poland
334
Katowice, Poland
340
Katowice, Poland
342
Lublin, Poland
341
Poznan, Poland
338
Szczecin, Poland
343
Warszawa, Poland
Portugal
360
Coimbra, Portugal
362
Lisboa, Portugal
365
Lisboa, Portugal
366
Porto, Portugal
361
Santa Maria Da Feira, Portugal
Romania
576
Bucuresti, Romania
569
Cluj-Napoca, Romania
578
Craiova, Romania
570
Iasi, Romania
579
Iasi, Romania
571
Sibiu, Romania
577
Sibiu, Romania
572
Targu Mures, Romania
Russian Federation
387
Kazan, Russian Federation
389
Kazan, Russian Federation
396
Kirov, Russian Federation
401
Moscow, Russian Federation
394
Moscow, Russian Federation
390
Nizhny Novgorod, Russian Federation
392
Novosibirsk, Russian Federation
400
Saint-Petersburg, Russian Federation
386
Smolensk, Russian Federation
397
St. Petersburg, Russian Federation
399
Yaroslavl, Russian Federation
Slovakia
594
Dolni Kubin, Slovakia
598
Dubnica nad Vahom, Slovakia
596
Hlohovec, Slovakia
600
Krompachy, Slovakia
595
Levoca, Slovakia
599
Tornala, Slovakia
601
Zilina, Slovakia
Spain
422
Badalona, Spain
413
Barcelona, Spain
419
La Laguna, Spain
416
Madrid, Spain
425
Madrid, Spain
426
Madrid, Spain
421
Murcia (El Palmar), Spain
418
San Sebastian, Spain
414
Santiago de Compostela, Spain
424
Sevilla, Spain
Sweden
440
Göteborg, Sweden
438
Stockholm, Sweden
442
Umea, Sweden
Switzerland
651
Aarau, Switzerland
654
Biel, Switzerland
653
Lugano, Switzerland
647
St. Gallen, Switzerland
649
Zürich, Switzerland
Thailand
702
Bangkok, Thailand
703
Bangkok, Thailand
699
Bangkok, Thailand
698
Khon Kaen, Thailand
Ukraine
622
Chernihiv, Ukraine
628
Dnipropetrovsk, Ukraine
626
Kharkov, Ukraine
621
Luhansk, Ukraine
625
Odesa, Ukraine
632
Simferopol, Ukraine
633
Vinnytsa, Ukraine
United Kingdom
466
Birmingham, United Kingdom
472
Glasgow, United Kingdom
471
Stoke-on-Trent, United Kingdom
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
EDEV S.À.R.L
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB BIOSCIENCES GmbH )
ClinicalTrials.gov Identifier: NCT01243177     History of Changes
Other Study ID Numbers: SP0993, 2010-019765-28
Study First Received: November 16, 2010
Last Updated: November 13, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Mexico: Federal Commission for Protection Against Health Risks
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Swissmedic
Thailand: Ministry of Public Health
Philippines: Bureau of Food and Drugs
Lithuania: State Medicine Control Agency - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Latvia: State Agency of Medicines
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by UCB Pharma:
Lacosamide
Vimpat®
Epilepsy
Monotherapy
Velocity

Additional relevant MeSH terms:
Lacosamide
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carbamazepine
Analgesics
Analgesics, Non-Narcotic
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014