Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 11 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465997
Recruitment Status : Completed
First Posted : November 6, 2011
Results First Posted : August 2, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborator:
Eden Sarl
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )

Brief Summary:
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).

Condition or disease Intervention/treatment Phase
Epilepsy Monotherapy Drug: Lacosamide Drug: Carbamazepine-Controlled Release (CBZ-CR) Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 551 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.
Study Start Date : May 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Drug: Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Other Name: VIMPAT film-coated tablets

Active Comparator: Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)
Drug: Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Other Name: Tegretol® Retard Tablets 200 mg




Primary Outcome Measures :
  1. Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) [ Time Frame: Up to 3.5 Years (Duration of the Treatment Phase) ]
    Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.

  2. Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) [ Time Frame: Up to 3.5 Years (Duration of the Treatment Phase) ]
    Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.

  3. Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) [ Time Frame: Up to 3.5 Years (Duration of the Treatment Phase) ]
    A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject/legal representative is considered reliable and capable of adhering to the protocol
  • Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
  • Subject is expected to benefit from participation in SP0994 in the opinion of the investigator

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
  • Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
  • Subject is taking benzodiazepines for a non-epilepsy indication
  • Subject meets a withdrawal criterion from the previous study SP0993
  • Subject is experiencing an ongoing SAE from the previous study SP0993
  • Subject has a lifetime history of suicide attempt (including an active 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. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465997


Locations
Hide Hide 150 study locations
Layout table for location information
United States, Alabama
786
Alabaster, Alabama, United States
799
Huntsville, Alabama, United States
United States, Arkansas
777
Little Rock, Arkansas, United States
United States, Florida
789
Panama City, Florida, United States
776
Port Charlotte, Florida, United States
United States, North Carolina
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
Australia
104
Chatswood, Australia
105
Clayton, Australia
106
East Gosford, Australia
101
Fitzroy, Australia
108
Heidelberg, Australia
103
Herston, Australia
109
Randwick, 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
811
Sofia, Bulgaria
809
Veliko Tarnovo, Bulgaria
Canada
152
Greenfield Park, Canada
158
Halifax Nova Scotia, Canada
156
Hamilton, Canada
153
St. John's, Canada
Czechia
185
Brno, Czechia
190
Ostrava - Vitkovice, Czechia
184
Praha 5, Czechia
189
Praha 6, Czechia
180
Zlin, Czechia
Finland
205
Helsinki, Finland
207
Kuopio, Finland
France
236
Nancy, France
Germany
263
Altenburg, Germany
265
BAD Neustadt, Germany
257
Berlin, Germany
262
Berlin, Germany
270
Berlin, Germany
260
Goettingen, Germany
269
Leipzig, Germany
256
Marburg, Germany
259
Osnabrück, Germany
Greece
495
Ioannina, Greece
490
Thessalonikis, Greece
493
Thessalonikis, Greece
Hungary
289
Balassagyarmat, Hungary
283
Budapest, Hungary
284
Budapest, Hungary
286
Debrecen, Hungary
282
Gyor, Hungary
285
Szeged, Hungary
290
Szekszárd, Hungary
291
Szombathely, Hungary
Italy
310
Bari, 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
843
Miyazaki-shi, Japan
835
Nagoya-shi, Japan
837
Okayama-shi, Japan
828
Saitama-shi, Japan
847
Sapporo, Japan
832
Shizuoka-shi, Japan
Korea, Republic of
525
Busan, Korea, Republic of
521
Daegu, Korea, Republic of
518
Daejeon, Korea, Republic of
517
Seoul, Korea, Republic of
519
Seoul, Korea, Republic of
520
Seoul, Korea, Republic of
523
Seoul, Korea, Republic of
524
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
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
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
394
Moscow, Russian Federation
401
Moscow, Russian Federation
390
Nizhny Novgorod, Russian Federation
392
Novosibirsk, Russian Federation
397
Saint-Petersburg, Russian Federation
400
Saint-Petersburg, Russian Federation
386
Smolensk, 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
417
Girona, Spain
419
La Laguna, Spain
416
Madrid, Spain
425
Madrid, Spain
418
San Sebastián, Spain
414
Santiago de Compostela, Spain
424
Sevilla, Spain
Sweden
440
Göteborg, Sweden
442
Linköping, Sweden
438
Stockholm, Sweden
Switzerland
651
Aarau, Switzerland
654
Biel, Switzerland
653
Lugano, Switzerland
Thailand
699
Bangkok, Thailand
702
Bangkok, Thailand
698
Khon Kaen, Thailand
Ukraine
622
Chernihiv, Ukraine
626
Kharkov, Ukraine
621
Luhansk, Ukraine
625
Odesa, Ukraine
632
Simferopol, Ukraine
United Kingdom
472
Glasgow, United Kingdom
471
Stoke-on-Trent, United Kingdom
Sponsors and Collaborators
UCB BIOSCIENCES GmbH
Eden Sarl
Investigators
Layout table for investigator information
Study Director: UCB Cares +1 877 822 9493 (UCB)

Additional Information:
Layout table for additonal information
Responsible Party: UCB BIOSCIENCES GmbH
ClinicalTrials.gov Identifier: NCT01465997    
Other Study ID Numbers: SP0994
2010-021238-74 ( EudraCT Number )
First Posted: November 6, 2011    Key Record Dates
Results First Posted: August 2, 2017
Last Update Posted: July 18, 2018
Last Verified: September 2017
Keywords provided by UCB Pharma ( UCB BIOSCIENCES GmbH ):
Lacosamide
Additional relevant MeSH terms:
Layout table for MeSH terms
Carbamazepine
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents