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

UCB Biopharma S.P.R.L.106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Epilepsy

Interventions

LacosamideDRUG

* Pharmaceutical Form: Oral tablets * Concentration: 50 mg * Route of Administration: Oral administration

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

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.

Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)

Percentage of Participants That Withdrew Due to Adverse Events (AEs)

Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)

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.

Time frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)

Data from ClinicalTrials.gov

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Sp1042 805

Blagoevgrad, Bulgaria

Sp1042 807

Pazardzhik, Bulgaria

Sp1042 811

Sofia, Bulgaria

Sp1042 205

Helsinki, Finland

Sp1042 207

Kuopio, Finland

Sp1042 236

Nancy, France

Sp1042 263

Altenburg, Germany

Sp1042 265

Bad Neustadt an der Saale, Germany

Sp1042 269

Leipzig, Germany

Sp1042 256

Marburg, Germany

...and 36 more locations