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

NCT02582866 | Completed Phase 3 Results

• 2 other identifiers: SP10422015-001549-96
• Study Type: interventional
• Target: 106
• Locations: 15 countries
• Sites: 46

Brief 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.

Conditions

Epilepsy

Keywords

Lacosamide; Vimpat; Epilepsy; Partial onset seizures; Tonic-clonic seizures; Monotherapy; AED

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (1)

Lacosamide

EXPERIMENTAL

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

Interventions

Lacosamide DRUG

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

Also known as: Vimpat, SPM927, LCM

Lacosamide

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead
• Parexel: collaborator

Study Sites (46)

Sp1042 805

Blagoevgrad, Bulgaria

Location

Sp1042 807

Pazardzhik, Bulgaria

Location

Sp1042 811

Sofia, Bulgaria

Location

Sp1042 205

Helsinki, Finland

Location

Sp1042 207

Kuopio, Finland

Location

Sp1042 236

Nancy, France

Location

Sp1042 263

Altenburg, Germany

Location

Sp1042 265

Bad Neustadt an der Saale, Germany

Location

Sp1042 269

Leipzig, Germany

Location

Sp1042 256

Marburg, Germany

Location

Sp1042 259

Osnabrück, Germany

Location

Sp1042 831

Asaka, Japan

Location

Sp1042 834

Kagoshima, Japan

Location

Sp1042 844

Kamakura, Japan

Location

Sp1042 835

Nagoya, Japan

Location

Sp1042 837

Okayama, Japan

Location

Sp1042 847

Sapporo, Japan

Location

Sp1042 751

Riga, Latvia

Location

Sp1042 547

San Luis Potosí City, Mexico

Location

Sp1042 672

Pasig, Philippines

Location

Sp1042 676

Quezon, Philippines

Location

Sp1042 340

Katowice, Poland

Location

Sp1042 342

Lublin, Poland

Location

Sp1042 343

Warsaw, Poland

Location

Sp1042 576

Bucharest, Romania

Location

Sp1042 570

Iași, Romania

Location

Sp1042 572

Târgu Mureş, Romania

Location

Sp1042 387

Kazan', Russia

Location

Sp1042 389

Kazan', Russia

Location

Sp1042 401

Moscow, Russia

Location

Sp1042 392

Novosibirsk, Russia

Location

Sp1042 397

Saint Petersburg, Russia

Location

Sp1042 400

Saint Petersburg, Russia

Location

Sp1042 521

Daegu, South Korea

Location

Sp1042 518

Daejeon, South Korea

Location

Sp1042 517

Seoul, South Korea

Location

Sp1042 519

Seoul, South Korea

Location

Sp1042 440

Gothenburg, Sweden

Location

Sp1042 442

Linköping, Sweden

Location

Sp1042 438

Stockholm, Sweden

Location

Sp1042 651

Aarau, Switzerland

Location

Sp1042 654

Biel, Switzerland

Location

Sp1042 653

Lugano, Switzerland

Location

Sp1042 622

Chernihiv, Ukraine

Location

Sp1042 626

Kharkiv, Ukraine

Location

Sp1042 625

Odesa, Ukraine

Location

Related 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 Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.

  PMID: 34265173 RESULT

• 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, controlled trial. Epilepsy Res. 2021 Oct;176:106705. doi: 10.1016/j.eplepsyres.2021.106705. Epub 2021 Jun 29.

  PMID: 34246118 RESULT

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Lacosamide; 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

+1844 599

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 6, 2023
• Results First Posted: January 22, 2021

Record last verified: 2023-05

Locations

BU (3); FR (1); RU (6); UA (3); FI (2); SE (3); KR (4); PH (2); JP (6); LA (1); CH (3); PL (3); ME (1); RO (3); DE (5)