Special Drug Use Investigation for LAMICTAL® (Long Term)

Epilepsy Clinical Trial

Official title:

Special Drug Use Investigation for LAMICTAL (Long Term)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863602
• Other study ID #: 112728
• Status: Completed
• Phase: N/A
• First received: October 4, 2012
• Last updated: November 8, 2016
• Start date: April 2009
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Lamotrigine tablets
Administered for long-term according to the prescribing information in the locally approved label by the authorities.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse drug reactions		1 year	No
Primary	Occurrence of skin disorder after the start of treatment	Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item	1 year	No
Secondary	Overall improvement of subjects' symptoms	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.	1 year	No