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Clinical Trials/EUCTR2014-004375-23-Outside-EU/EEA
EUCTR2014-004375-23-Outside-EU/EEA
Active, not recruiting
Not Applicable

An open-label extension study to assess the safety andseizure frequency associated with long-term orallacosamide for uncontrolled primary generalizedtonic-clonic seizures in subjects with idiopathic generalizedepilepsy

CB BIOSCIENCES, Inc.0 sites45 target enrollmentMarch 23, 2015
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ConditionsEpilepsyMedDRA version: 17.1Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsVimpat

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
CB BIOSCIENCES, Inc.
Enrollment
45
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 23, 2015
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CB BIOSCIENCES, Inc.

Eligibility Criteria

Inclusion Criteria

  • •\- Subject completed the SP0961 (2014\-004379\-22\) study
  • •\- Subject is expected to benefit from participation in an open\-label extension study with Lacosamide, in the opinion of the investigator
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 5
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 40
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •\- Subject meets the withdrawal criteria for SP0961 (2014\-004379\-22\) or is experiencing an ongoing Serious Adverse Event (SAE)

Outcomes

Primary Outcomes

Not specified

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