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

Epilepsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465997
• Other study ID #: SP0994
• Secondary ID: 2010-021238-74
• Status: Completed
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: January 2017

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Monotherapy

Intervention

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)
• 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)

Locations

Country	Name	City	State
Australia	104	Chatswood
Australia	105	Clayton
Australia	106	East Gosford
Australia	101	Fitzroy
Australia	108	Heidelberg
Australia	103	Herston
Australia	109	Randwick
Belgium	127	Brugge
Belgium	134	Brugge
Belgium	128	Hasselt
Belgium	126	Leuven
Bulgaria	805	Blagoevgrad
Bulgaria	807	Panagyurishte
Bulgaria	803	Pleven
Bulgaria	810	Russe
Bulgaria	811	Sofia
Bulgaria	809	Veliko Tarnovo
Canada	152	Greenfield Park
Canada	158	Halifax Nova Scotia
Canada	156	Hamilton
Canada	153	St. John's
Czechia	185	Brno
Czechia	190	Ostrava - Vitkovice
Czechia	184	Praha 5
Czechia	189	Praha 6
Czechia	180	Zlin
Finland	205	Helsinki
Finland	207	Kuopio
France	236	Nancy
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
Greece	495	Ioannina
Greece	490	Thessalonikis
Greece	493	Thessalonikis
Hungary	289	Balassagyarmat
Hungary	283	Budapest
Hungary	284	Budapest
Hungary	286	Debrecen
Hungary	282	Gyor
Hungary	285	Szeged
Hungary	290	Szekszárd
Hungary	291	Szombathely
Italy	310	Bari
Italy	309	Modena
Italy	308	Padova
Italy	314	Prato
Italy	311	Roma
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
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
Latvia	751	Riga
Lithuania	727	Alytus
Lithuania	724	Kaunas
Lithuania	728	Vilnius
Mexico	547	San Luis Potosi
Philippines	673	Manila
Philippines	672	Pasig City
Philippines	676	Quezon City
Poland	336	Gdansk
Poland	340	Katowice
Poland	342	Lublin
Poland	341	Poznan
Poland	338	Szczecin
Poland	343	Warszawa
Portugal	360	Coimbra
Portugal	362	Lisboa
Portugal	365	Lisboa
Portugal	366	Porto
Portugal	361	Santa Maria da Feira
Romania	576	Bucuresti
Romania	569	Cluj-napoca
Romania	570	Iasi
Romania	579	Iasi
Romania	571	Sibiu
Romania	577	Sibiu
Romania	572	Targu Mures
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
Slovakia	594	Dolni Kubin
Slovakia	598	Dubnica Nad Vahom
Slovakia	596	Hlohovec
Slovakia	600	Krompachy
Slovakia	595	Levoca
Slovakia	599	Tornala
Slovakia	601	Zilina
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
Sweden	440	Göteborg
Sweden	442	Linköping
Sweden	438	Stockholm
Switzerland	651	Aarau
Switzerland	654	Biel
Switzerland	653	Lugano
Thailand	699	Bangkok
Thailand	702	Bangkok
Thailand	698	Khon Kaen
Ukraine	622	Chernihiv
Ukraine	626	Kharkov
Ukraine	621	Luhansk
Ukraine	625	Odesa
Ukraine	632	Simferopol
United Kingdom	472	Glasgow
United Kingdom	471	Stoke-on-Trent
United States	786	Alabaster	Alabama
United States	799	Huntsville	Alabama
United States	777	Little Rock	Arkansas
United States	790	Madison	Wisconsin
United States	881	Mansfield	Texas
United States	794	Oklahoma City	Oklahoma
United States	789	Panama City	Florida
United States	776	Port Charlotte	Florida
United States	873	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UCB BIOSCIENCES GmbH	Eden Sarl

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)	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.	Up to 3.5 Years (Duration of the Treatment Phase)
Primary	Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)	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.	Up to 3.5 Years (Duration of the Treatment Phase)
Primary	Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)	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.	Up to 3.5 Years (Duration of the Treatment Phase)

External Links

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