EpilepsyNCT01863602
Special Drug Use Investigation for LAMICTAL® (Long Term)
An observational study of Epilepsy, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- What is being tested?
- Lamotrigine tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 850 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
- Subjects who are treated with lamotrigine tablets
Who cannot join
- None
About this study
Official title: Special Drug Use Investigation for LAMICTAL (Long Term)
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.
- Conditions
- Epilepsy
- Being tested
- Lamotrigine tablets
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine tabletsDrug
Administered for long-term according to the prescribing information in the locally approved label by the authorities.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lamotrigine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse drug reactions
Measured: 1 year
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
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startApr 2009
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863602
- Sponsor's protocol ID
- 112728
- Status last verified
- Nov 2016
- First submitted
- 4 Oct 2012
- Last updated
- 9 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for LAMICTAL (Long Term)
- ClinicalTrials.gov ID
- NCT01863602
- Acronym / sponsor ID
- 112728
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects prescribed lamotrigine tablets | – | Drug: Lamotrigine tabletsSubjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome to whom lamotrigine tablets are administered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Subjects with epilepsy with partial seizures, tonic-clonic seizuresm or generalized seizures of Lennox-Gastaut syndrome
- Subjects who are treated with lamotrigine tablets
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamotrigine tabletsAdministered for long-term according to the prescribing information in the locally approved label by the authorities. | Drug | Subjects prescribed lamotrigine tablets |
Primary outcome
The incidence of adverse drug reactions
Time frame: 1 year
Occurrence of skin disorder after the start of treatment
Time frame: 1 year
Presence or absence of skin disorder and its details after the start of treatment will be investigated as a priority investigation item
1 secondary outcome
Overall improvement of subjects' symptoms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of adverse drug reactions (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.