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Completed

NCT Number: NCT00044278

Pediatric Epilepsy Study in Subjects 1-24 Months

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Capital Federal, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have completed the Open-Label Phase of protocol LAM20006 or meet criteria for LAMICTAL naive subjects as follows:
  • A confident diagnosis of epilepsy.
  • 4 or more partial seizures per month.
  • current treatment with 1 or 2 anti-epileptic drugs.

Exclusion criteria

  • Has seizures not related to epilepsy.
  • Has a surgically implanted and functioning vagal nerve stimulator.
  • Has previously been treated with lamotrigine.
  • Is currently taking felbamate, ACTH (adrenocorticotrophic hormone) or is on the ketogenic diet.
  • Use of experimental medication within 30 days of enrollment.

Treatment and study plan

Lamotrigine

Drug

Primary outcomes

  1. Number of participants with overall, serious, drug-related treatment emergent adverse events and adverse events leading to premature study discontinuation

    Time frame: 43 Months

  2. Change from baseline in vital signs -heart rate (HR)

    Time frame: Up to 43 Months

  3. Change from baseline in vital signs - weight (WT)

    Time frame: Up to 43 months

  4. Change from baseline in vital signs - height (HT)

    Time frame: Up to 43 months

  5. Change from baseline in vital signs - head circumference (HC)

    Time frame: Up to 43 months

  6. Change from baseline in clinical chemistry parameters including Albumin and Total protein

    Time frame: Up to month 43

  7. Change from baseline in clinical chemistry parameters including alkaline phosphatase, Alanine transaminase (ALT), and Aspartate Aminotransferase (AST)

    Time frame: Up to 43 moths

  8. Change from baseline in clinical chemistry parameters including total bilirubin and creatinine

    Time frame: Up to 43 months

  9. Change from baseline in clinical chemistry parameters including glucose (glu), potassium (K), sodium (Na) and urea

    Time frame: Up to 43 months

  10. 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

  11. Change from baseline in Hemoglobin (Hb)

    Time frame: Up to 43 months

  12. Change from baseline in Mean corpuscular hemoglobin (MCH)

    Time frame: Up to 43 months

  13. Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)

    Time frame: Up to 43 months

  14. Change from baseline in mean corpuscular volume (MCv)

    Time frame: Up to 43 months

  15. Change from baseline in red blood cells (RBC)

    Time frame: Up to 43 months

  16. Number of participants with treatment emergent neurological abnormalities

    Time frame: Up to 43 months

  17. Number of participants with treatment emergent clinically significant ECG abnormalities

    Time frame: Up to 43 months

  18. Number of participants with potentially clinically significant change in hematology parameters

    Time frame: Up to 43 months

  19. Number of participants with potentially clinically significant change in clinical chemistry parameters

    Time frame: Up to 43 months

  20. Number of participants with potentially clinically significant change in vital signs

    Time frame: Up to 43 months

Secondary outcomes

  1. 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

  2. Investigator's assessment of the participant's overall clinical status

    Time frame: Up to 43 months

  3. Mean Maximal plasma concentration (Cmax) in serum and saliva of Lamicital -naïve participants

    Time frame: Week 6

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Aug 26, 2002
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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