Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

Partial Epilepsies Clinical Trial

Official title:

An Open-Label, Multicenter, Multinational Study of Lacosamide as First Add-On Anti-epileptic Drug (AED) Treatment in Subjects With Partial-Onset Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00955357
• Other study ID #: SP0954
• Secondary ID: 2009-011181-28
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: August 2013

Study information

• Verified date: July 2017
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of oral Lacosamide as first add on treatment in subjects with uncontrolled partial-onset seizures after prior treatment with a monotherapy Antiepileptic Drug (AED) regimen compared to subjects who have received treatment with at least 2 AEDs.

Description:

The study consisted of 3 Periods: Period 1: a 1-week Screening Phase, Period 2: a 30-week Treatment Phase (consisting of a 6-week Titration Phase and a 24-week Maintenance Phase), and Period 3: a 3-week Taper/Safety Follow-Up Phase.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: August 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

Group 1:

• Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization

• Currently taking adequate monotherapy (defined as a single Antiepileptic Drug (AED) for at least 28 days prior to Screening) and has no history of AED polytherapy. Prior use of rescue medication (short-term intermittent use) is acceptable

• Epilepsy diagnosis should be =24 months at the time of the Screening Visit

• The minimum allowed seizure frequency at any time during the 12 weeks prior to the Screening Visit is =3 partial-onset seizures

Group 2:

• Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures with or without secondary generalization

• Currently taking 1 to 3 AEDs, and has tried at least 2 prior AED treatment regimens (concurrently or sequentially)

• Epilepsy diagnosis should be =5 years at the time of the Screening Visit

• The minimum allowed seizure frequency during the 12 weeks prior to the Screening Visit is =1 partial-onset seizure per 28 days

Exclusion Criteria:

• Previous use of Lacosamide

• History of seizure disorder characterized primarily by isolated auras

• History of primary generalized seizures

• History of status epilepticus within last 12-months

• History of cluster seizures during the 12 week period prior to Visit 1

• Nonepileptic events, including pseudoseizures that could be confused with seizure

• Lifetime history of suicide attempt or suicidal ideation in the past 6 months

• Hypersensitivity to any component of Lacosamide

• History of drug or alcohol abuse

• History of an acute or subacutely progressive Central Nervous System (CNS) disease

• Undergone cranial surgery within the last year prior to study entry

• Concomitant treatment of Felbamate or previous Felbamate therapy within the last 6 months

• Prior or concomitant Vigabatrin use

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsies
• Seizures

Intervention

Drug:
• Lacosamide
Oral Lacosamide: Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Locations

Country	Name	City	State
Austria	503	Wien
Bulgaria	703	Blagoevrad
Bulgaria	706	Pleven
Bulgaria	700	Sofia
Bulgaria	702	Sofia
Bulgaria	704	Sofia
Bulgaria	705	Sofia
Bulgaria	707	Sofia
Bulgaria	708	Sofia
Bulgaria	701	Varna
Czechia	736	Hradec Kralove
Czechia	735	Litomerice
Czechia	733	Ostrava
Czechia	732	Ostrava-Hrabuvka
Czechia	737	Praha 11
Czechia	734	Trutnov
Denmark	930	Aarhus
Finland	400	Helsinki
Finland	402	Oulu
Finland	401	Tampere
France	610	Strasbourg
France	611	Toulon
Greece	521	Athens
Greece	520	Thessaloniki
Italy	552	Faenza
Italy	546	Gallarate
Italy	541	Napoli
Italy	559	Pietra Ligure
Italy	557	Prato
Italy	540	Roma
Italy	549	Roma
Italy	542	Taranto
Italy	547	Torino
Italy	551	Trieste
Mexico	180	Aguascalientes
Mexico	183	Chihuahua
Mexico	185	Chihuahua
Mexico	184	Ciudad Juarez
Mexico	189	Guadalajara
Mexico	181	Mexico DF
Mexico	193	Mexico DF
Mexico	195	Mexico DF
Mexico	186	Monterrey
Mexico	187	Monterrey
Mexico	188	Monterrey
Mexico	182	Polanco
Romania	815	Bucarest
Romania	810	Cluj-napoca
Romania	814	Oradea
Romania	813	Targu Mures
Russian Federation	830	Kazan
Russian Federation	831	Kazan
Russian Federation	834	Moscow
Russian Federation	833	Novosibirsk
Spain	592	Almeria
Spain	597	Bajo Sevilla
Spain	590	Barcelona
Spain	596	Santiago de Compostela
Spain	598	Terrassa	Barcelona
Spain	594	Valencia
Spain	599	Valladolid
Switzerland	892	Lausanne
Turkey	713	Adana
Turkey	714	Ankara
Turkey	710	Eskisehir
Turkey	711	Istanbul
Turkey	719	Istanbul
Turkey	717	Izmir
Turkey	718	Trabzon
United States	134	Akron	Ohio
United States	101	Annapolis	Maryland
United States	108	Atlanta	Georgia
United States	112	Atlanta	Georgia
United States	124	Augusta	Georgia
United States	148	Austin	Texas
United States	139	Bismarck	North Dakota
United States	153	Boston	Massachusetts
United States	102	Bowling Green	Kentucky
United States	109	Brooklyn	New York
United States	133	Brooklyn	New York
United States	150	Canton	Ohio
United States	158	Charlotte	North Carolina
United States	156	Clearwater	Florida
United States	120	Columbia	South Carolina
United States	154	Dallas	Texas
United States	130	Des Moines	Iowa
United States	157	Destin	Florida
United States	128	Flossmoor	Illinois
United States	119	Fredericksburg	Virginia
United States	140	Hollywood	Florida
United States	107	Houma	Louisiana
United States	121	Indiana	Pennsylvania
United States	103	Irvine	California
United States	151	Kansas City	Missouri
United States	115	Macon	Georgia
United States	161	Ocala	Florida
United States	149	Orangeburg	South Carolina
United States	117	Paducah	Kentucky
United States	114	Paterson	New Jersey
United States	136	Pittsfield	Massachusetts
United States	123	Rancho Mirage	California
United States	118	Rome	Georgia
United States	145	Ruston	Louisiana
United States	152	Spartanburg	South Carolina
United States	144	Springfield	Massachusetts
United States	146	Tomball	Texas
United States	141	Tulsa	Oklahoma
United States	162	Waldorf	Maryland
United States	127	West Seneca	New York

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Czechia,  Denmark,  Finland,  France,  Greece,  Italy,  Mexico,  Romania,  Russian Federation,  Spain,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase	A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.; This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.	From Week 7 (end of Week 6) to end of Week 18

External Links

•   FDA Safety Alerts and Recalls
•   Product Information