Pediatric Epilepsy Study in Subjects 1-24 Months

NCT00044278 | Completed Phase 2

• 1 other identifier: LAM20007
• Study Type: interventional
• Target: 197
• Locations: 15 countries
• Sites: 70

Brief Summary

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.

Conditions

Epilepsy

Keywords

epilepsy; pediatric; partial seizures

Outcome Measures

Primary Outcomes (20)

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

  43 Months

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

  Up to 43 Months

• Change from baseline in vital signs - weight (WT)

  Up to 43 months

• Change from baseline in vital signs - height (HT)

  Up to 43 months

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

  Up to 43 months

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

  Up to month 43

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

  Up to 43 moths

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

  Up to 43 months

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

  Up to 43 months

• Change from baseline in hematological parameters including bands, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and total white blood cells (WBC)

  Up to 43 moths

• Change from baseline in Hemoglobin (Hb)

  Up to 43 months

• Change from baseline in Mean corpuscular hemoglobin (MCH)

  Up to 43 months

• Change from baseline in Mean corpuscular hemoglobin concentration (MCHC)

  Up to 43 months

• Change from baseline in mean corpuscular volume (MCv)

  Up to 43 months

• Change from baseline in red blood cells (RBC)

  Up to 43 months

• Number of participants with treatment emergent neurological abnormalities

  Up to 43 months

• Number of participants with treatment emergent clinically significant ECG abnormalities

  Up to 43 months

• Number of participants with potentially clinically significant change in hematology parameters

  Up to 43 months

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

  Up to 43 months

• Number of participants with potentially clinically significant change in vital signs

  Up to 43 months

Secondary Outcomes (3)

• Mean percentage change in seizure frequency between the Historical Baseline Phase and over the course of the 48-week Treatment Phase

  Up to 48 Weeks

• Investigator's assessment of the participant's overall clinical status

  Up to 43 months

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

  Week 6

Interventions

lamotrigine DRUG

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (70)

GSK Investigational Site

Mobile, Alabama, 36693, United States

Location

GSK Investigational Site

Tucson, Arizona, 85712, United States

Location

GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

Location

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Little Rock, Arkansas, 72202, United States

Location

GSK Investigational Site

Los Angeles, California, 90027, United States

Location

GSK Investigational Site

Los Angeles, California, 90095, United States

Location

GSK Investigational Site

Stanford, California, 94305-5235, United States

Location

GSK Investigational Site

Denver, Colorado, 80218, United States

Location

GSK Investigational Site

Washington D.C., District of Columbia, 20010, United States

Location

GSK Investigational Site

Jacksonville, Florida, 32207, United States

Location

GSK Investigational Site

Miami, Florida, 33155-3009, United States

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GSK Investigational Site

Orlando, Florida, 32835, United States

Location

GSK Investigational Site

Tallahassee, Florida, 32308, United States

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GSK Investigational Site

Tampa, Florida, 33609, United States

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GSK Investigational Site

Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30912, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40536-0284, United States

Location

GSK Investigational Site

Saint Paul, Minnesota, 55102-2383, United States

Location

GSK Investigational Site

Columbia, Missouri, 65211, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64108, United States

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Cherry Hill, New Jersey, 8034, United States

Location

GSK Investigational Site

Buffalo, New York, 14222, United States

Location

GSK Investigational Site

Mineola, New York, 11501, United States

Location

GSK Investigational Site

Syracuse, New York, 13210, United States

Location

GSK Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27607, United States

Location

GSK Investigational Site

Akron, Ohio, 44308-1062, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44106, United States

Location

GSK Investigational Site

Columbus, Ohio, 43205, United States

Location

GSK Investigational Site

Portland, Oregon, 97201-2884, United States

Location

GSK Investigational Site

Portland, Oregon, 97201-2984, United States

Location

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Pittsburgh, Pennsylvania, 15213-2583, United States

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Morristown, Tennessee, 37813, United States

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GSK Investigational Site

Nashville, Tennessee, 37212, United States

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GSK Investigational Site

Dallas, Texas, 75230, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84113, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22908, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23507, United States

Location

GSK Investigational Site

Richmond, Virginia, 23298, United States

Location

GSK Investigational Site

Capital Federal, Buenos Aires, 1181, Argentina

Location

GSK Investigational Site

Buenos Aires, 1425, Argentina

Location

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Parkville, Melbourne, Victoria, 3050, Australia

Location

GSK Investigational Site

Tartu, 51014, Estonia

Location

GSK Investigational Site

Reims, 51092, France

Location

GSK Investigational Site

Budapest, 1094, Hungary

Location

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Debrecen, 4012, Hungary

Location

GSK Investigational Site

Miskolc, 3526, Hungary

Location

GSK Investigational Site

Pécs, 7623, Hungary

Location

GSK Investigational Site

Szeged, 6720, Hungary

Location

GSK Investigational Site

Napoli, Campania, 80131, Italy

Location

GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

Location

GSK Investigational Site

Mantova, Lombardy, 46100, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20133, Italy

Location

GSK Investigational Site

Messina, Sicily, 98125, Italy

Location

GSK Investigational Site

Padua, Veneto, 35128, Italy

Location

GSK Investigational Site

Riga, LV 1004, Latvia

Location

GSK Investigational Site

Beirut, 11072020, Lebanon

Location

GSK Investigational Site

Kaunas, LT-50009, Lithuania

Location

GSK Investigational Site

Groningen, 9713 GZ, Netherlands

Location

GSK Investigational Site

Rotterdam, 3015 GD, Netherlands

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GSK Investigational Site

Utrecht, 3584 EA, Netherlands

Location

GSK Investigational Site

Coimbra, 3000-075, Portugal

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GSK Investigational Site

Lisbon, 1150, Portugal

Location

GSK Investigational Site

Porto, 4099-001, Portugal

Location

GSK Investigational Site

SanJuan, Puerto Rico, 00936, Puerto Rico

Location

GSK Investigational Site

Bratislava, 833 40, Slovakia

Location

GSK Investigational Site

Prešov, 080 01, Slovakia

Location

GSK Investigational Site

Ankara, Turkey (Türkiye)

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2002
• First Posted: August 26, 2002
• Study Start: September 1, 2000
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); PT (3); LE (1); LA (1); PR (1); AU (1); ES (1); US (41); TU (1); IT (6); AR (2); HU (5); NL (3); SL (2); LI (1)