A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

Epilepsy Clinical Trial

Official title:

A Multicenter, Open-label, Follow-up Study to Assess the Long-term Use of Lacosamide (Flexible Dose From 200 to 600 mg/Day) Used as Monotherapy in Subjects Who Completed SP0994 and Received Lacosamide Monotherapy Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582866
• Other study ID #: SP1042
• Secondary ID: 2015-001549-96
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: May 2023
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• An Institutional Review Board /Institutional Ethics Committee approved written Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
• Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator
• Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been treated with lacosamide monotherapy

Exclusion Criteria:

• Subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (LCM)
• Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during SP0994
• Subject required another Anti Epileptic Drug (AED) for the treatment of seizures
• Subject meets a "must" withdrawal criteria for SP0994
• Subject is experiencing an ongoing Serious Adverse Event from SP0994
• Female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception, unless sexually abstinent, for the duration of the study

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Lacosamide
Pharmaceutical Form: Oral tablets Concentration: 50 mg Route of Administration: Oral administration

Locations

Country	Name	City	State
Bulgaria	Sp1042 805	Blagoevgrad
Bulgaria	Sp1042 807	Pazardzhik
Bulgaria	Sp1042 811	Sofia
Finland	Sp1042 205	Helsinki
Finland	Sp1042 207	Kuopio
France	Sp1042 236	Nancy
Germany	Sp1042 263	Altenburg
Germany	Sp1042 265	Bad Neustadt An Der Saale
Germany	Sp1042 269	Leipzig
Germany	Sp1042 256	Marburg
Germany	Sp1042 259	Osnabruck
Japan	Sp1042 831	Asaka
Japan	Sp1042 834	Kagoshima
Japan	Sp1042 844	Kamakura
Japan	Sp1042 835	Nagoyashi
Japan	Sp1042 837	Okayama
Japan	Sp1042 847	Sapporo
Korea, Republic of	Sp1042 521	Daegu
Korea, Republic of	Sp1042 518	Daejeon
Korea, Republic of	Sp1042 517	Seoul
Korea, Republic of	Sp1042 519	Seoul
Latvia	Sp1042 751	Riga
Mexico	Sp1042 547	San Luis Potosi
Philippines	Sp1042 672	Pasig
Philippines	Sp1042 676	Quezon
Poland	Sp1042 340	Katowice
Poland	Sp1042 342	Lublin
Poland	Sp1042 343	Warszawa
Romania	Sp1042 576	Bucuresti
Romania	Sp1042 570	Iasi
Romania	Sp1042 572	Targu Mures
Russian Federation	Sp1042 387	Kazan
Russian Federation	Sp1042 389	Kazan
Russian Federation	Sp1042 401	Moscow
Russian Federation	Sp1042 392	Novosibirsk
Russian Federation	Sp1042 397	Saint Petersburg
Russian Federation	Sp1042 400	Saint Petersburg
Sweden	Sp1042 440	Goteborg
Sweden	Sp1042 442	Linköping
Sweden	Sp1042 438	Stockholm
Switzerland	Sp1042 651	Aarau
Switzerland	Sp1042 654	Biel
Switzerland	Sp1042 653	Lugano
Ukraine	Sp1042 622	Chernihiv
Ukraine	Sp1042 626	Kharkov
Ukraine	Sp1042 625	Odesa

Sponsors (2)

Lead Sponsor	Collaborator
UCB Biopharma S.P.R.L.	Parexel

Countries where clinical trial is conducted

Bulgaria,  Finland,  France,  Germany,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Philippines,  Poland,  Romania,  Russian Federation,  Sweden,  Switzerland,  Ukraine, 

References & Publications (2)

Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia — View Citation

Inoue Y, Liao W, Wang X, Du X, Tennigkeit F, Sasamoto H, Osakabe T, Hoshii N, Yuen N, Hong Z. Safety and efficacy of adjunctive lacosamide in Chinese and Japanese adults with epilepsy and focal seizures: A long-term, open-label extension of a randomized, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.	From Visit 1 (Week 0) to Final Visit (up to Week 158)
Primary	Percentage of Participants That Withdrew Due to Adverse Events (AEs)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.	From Visit 1 (Week 0) to Final Visit (up to Week 158)
Primary	Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires in patient hospitalization or prolongation of existing hospitalization; Is a congenital anomaly or birth defect; Is an infection that requires treatment parenteral antibiotics; Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.	From Visit 1 (Week 0) to Final Visit (up to Week 158)

External Links

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