EUCTR2010-022534-84-DE
Active, not recruiting
Not Applicable
A multi-center, open-label, single-arm study to evaluate hormone and lipid levels in male subjects with partial onset seizures after a switch of treatment from carbamazepine as adjunctive treatment to levetiracetam to lacosamide as adjunctive treatment to levetiracetam.
CB Pharma SA0 sites28 target enrollmentFebruary 16, 2011
DrugsVimpat
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CB Pharma SA
- Enrollment
- 28
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.An Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject or legal representative.
- •2\.Subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the investigator.
- •3\.Subject is male and between 18 and 45 years of age, inclusive.
- •4\.Subject has a diagnosis of epilepsy with partial\-onset seizures according to the International Classification of Epileptic Seizures (1981\) (See Section 15\.1\).
- •5\.Subject is only taking LEV in combination with CBZ as adjunctive treatment for epilepsy.
- •6\.Subject has been treated with CBZ for at least 12 months before study entry.
- •7\.Subject has been maintained on a stable dose of CBZ and LEV during the 30 days before study entry.
- •8\.The dose of CBZ at Visit 1 is \=600mg/day to \=1200mg/day.
- •9\.The dose of LEV at Visit 1 is \=1000mg/day.
- •10\. A change from adjunctive treatment of CBZ and LEV to adjunctive treatment of LCM and LEV is expected to provide benefit to the subject, according to the clinical judgment of the investigator. These benefits may, for instance, be related to seizure control, tolerability of the treatment, endocrine/metabolic function, or drug\-drug interactions.
Exclusion Criteria
- •Subjects are not permitted to enroll in the study if any of the following criteria are met:
- •1\.Subject has previously participated in this study or subject has previously been assigned to treatment in a study of LCM.
- •2\.Subject has participated in another study of an investigational medicinal product (IMP) or an experimental medical device within the last 30 days or is currently participating in another study of an IMP or a medical device.
- •3\.Subject has a known hypersensitivity to any components of LCM tablets.
- •4\.Subject has taken an AED other than CBZ and LEV within the last 30 days, excepting 1 time use of benzodiazepines as rescue medication (less than or equal to 3 doses within 24 hours).
- •5\. Subject has taken lipid lowering agents within the last 30 days.
- •6\. Subject has taken any medication known to affect endocrine function within the last 30 days, including exogenous hormones (eg, thyroid hormone, anabolic steroids, androgens, or glucocorticoids).
- •7\.Subject has taken other enzyme inducers within the last 30 days (eg, St. John’s wort, rifampicin).
- •8\.Subject is suffering from a known endocrine disorder where the condition or its treatment might influence SHBG levels, reproductive hormones, thyroid hormones, or serum lipid levels.
- •9\.Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion.
Outcomes
Primary Outcomes
Not specified
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