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

• Register: ClinicalTrials.gov
• Last refreshed on: 30 August 2021
• Main ID: NCT02582866
• Date of registration: 20/10/2015
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
• Scientific 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
• Date of first enrolment: January 2016
• Target sample size: 106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02582866
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

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



Age minimum: 17 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Lacosamide

Primary Outcome(s)

Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator [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 [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)]

Secondary ID(s)

2015-001549-96

SP1042

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel

Results

• Results available: Yes
• Date Posted: 22/01/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02582866