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

NCT02582866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-06-06

Study results available
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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

Interventions

DRUG

Lacosamide

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 844 599 2273 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Bulgaria
  • Finland
  • France
  • Germany
  • Japan
  • Latvia
  • Mexico
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Korea
  • Sweden
  • Switzerland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582866 on ClinicalTrials.gov