A Phase 2 interventional study of lamotrigine in Epilepsy, sponsored by GlaxoSmithKline. Completed at 70 sites in 15 countries. Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 197 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation
Time frame: 43 Months
Change from baseline in vital signs -heart rate (HR)
Time frame: Up to 43 Months
Change from baseline in vital signs - weight (WT)
Time frame: Up to 43 months
Change from baseline in vital signs - height (HT)
Time frame: Up to 43 months
Change from baseline in vital signs - head circumference (HC)
Time frame: Up to 43 months
Change from baseline in clinical chemistry parameters including Albumin and Total protein
Time frame: Up to month 43
Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)
Time frame: Up to 43 moths
Change from baseline in clinical chemistry parameters including total bilirubin and creatinine
Time frame: Up to 43 months
Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea
Time frame: Up to 43 months
Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)
Time frame: Up to 43 moths
Change from baseline in Hemoglobin (Hb)
Time frame: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin (MCH)
Time frame: Up to 43 months
Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)
Time frame: Up to 43 months
Change from baseline in mean corpuscular volume (MCv)
Time frame: Up to 43 months
Change from baseline in red blood cells (RBC)
Time frame: Up to 43 months
Number of participants with treatment emergent neurological abnormalities
Time frame: Up to 43 months
Number of participants with treatment emergent clinically significant ECG abnormalities
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in hematology parameters
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in clinical chemistry parameters
Time frame: Up to 43 months
Number of participants with potentially clinically significant change in vital signs
Time frame: Up to 43 months
Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase
Time frame: Up to 48 Weeks
Investigator's assessment of the participant's overall clinical status
Time frame: Up to 43 months
Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants
Time frame: Week 6
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline