Special Drug Use Investigation for LAMICTAL (Lamotrigine) Tablets for Long-term Use

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01863602
First received: October 4, 2012
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Epilepsy
Drug: Lamotrigine tablets

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for LAMICTAL (Lamotrigine) Tablets for Long-term Use

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The incidence of adverse drug reactions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Occurrence of skin disorder after the start of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item


Secondary Outcome Measures:
  • Overall improvement of subjects' symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Investigators will assess the overall improvement as "remarkably improved". "improved", "slightly improved", "unchanged" or "worsened" on the basis of the degree of change in frequency of seizures, strength, span and other related symptoms.


Estimated Enrollment: 600
Study Start Date: April 2009
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed lamotrigine tablets
Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered.
Drug: Lamotrigine tablets
Administered for long-term according to the prescribing information in the locally approved label by the authorities.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult (>=15 to <65 years) and pediatric (>=2 to <15 years) subjects with epilepsy with the following seizure type who use lamotrigine tablets

  • Partial seizures
  • Tonic-clonic seizures
  • Generalized seizures of Lennox-Gastaut syndrome
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01863602

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01863602     History of Changes
Other Study ID Numbers: 112728
Study First Received: October 4, 2012
Last Updated: June 26, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Lamotrigine
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on September 18, 2014