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Phase 2 Completed N=12 Diagnostic

Determination of Absorption and Elimination of Lamotrigine-XR

Source: ClinicalTrials.gov NCT00789113 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG — 142.8; 132.3 µg*h/mL

Summary

People over 65 years of ag break down (metabolize) drugs differently than younger adults. It is not known why this happens or how elderly people absorb or break down these drug differently. These difference may show that elderly individuals need lower doses of medications to avoid possible toxicity. We are interested in studying how yor body absorbs and breaks down your lamotrigine medication. This research may indicate that doses of lamotrigine should be lowered as people get older.

Outcome Measures

OutcomeResultp-value
PRIMARY
Area Under the Curve (AUC) for Oral Bioavailability of Lamotrigine (LTG
142.8; 132.3

Eligibility Criteria

Inclusion Criteria

  • Clinical Diagnosis of Epilepsy or Bipolar Depression
  • able to have a venus catheter implanted for blood withdrawal and for intravenous infusion
  • equal to or over the age of 65

Exclusion Criteria

  • not on any medication that will interact with lamotrigine e.g. carbamazepine, phenytoin, phenobarbital, valproic acid, St. John's wort, rifampin, tamoxifen
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00789113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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