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

May 10, 2023 updated by: UCB Biopharma S.P.R.L.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lacosamide

Lacosamide (LCM) will be administered orally twice daily from 200 mg/day to 600 mg/day (at approximately 12 hour intervals in the morning and in the evening) in 2 divided doses. Medication must not be chewed and must be swallowed with a sufficient amount of fluid. The investigator may maintain the subject's LCM dose, decrease the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increase the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day.

Subjects stopping LCM should be tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper is permitted, if medically necessary; however, the maximum duration of tapering should not exceed 6 weeks.
Drug: Lacosamide
  • Pharmaceutical Form: Oral tablets
  • Concentration: 50 mg
  • Route of Administration: Oral administration
Other Names:
  • Vimpat
  • LCM
  • SPM927

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)
Percentage of Participants That Withdrew Due to Adverse Events (AEs)
Time Frame: From Visit 1 (Week 0) to Final Visit (up to Week 158)
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)
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)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Biopharma S.P.R.L.

Collaborators

Parexel

Investigators

  • Study Director: UCB Cares, +1 844 599 2273 (UCB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimated)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP1042
  • 2015-001549-96 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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