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Special Drug Use Investigation for LAMICTAL® (Long Term)

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: Lamotrigine tablets (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

The objectives of this post-marketing surveillance (PMS) are to grasp the actual use of lamotrigine tablets to collect safety information in the long-term use according to seizure type and concomitant antiepileptic drug (AED), and to confirm its efficacy.

Clinical Details

Official title: Special Drug Use Investigation for LAMICTAL (Long Term)

Study design: Time Perspective: Prospective

Primary outcome:

The incidence of adverse drug reactions

Occurrence of skin disorder after the start of treatment

Secondary outcome: Overall improvement of subjects' symptoms

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized

seizures of Lennox-Gastaut syndrome

- Subjects who are treated with lamotrigine tablets

Exclusion Criteria:

- None

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: August 10, 2015

Page last updated: August 23, 2015

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