A Study of the Pharmacokinetics (PK) and Safety of IV Carbamazepine Relative to Oral Carbamazepine in Adults With Epilepsy

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety, tolerability and steady-state pharmacokinetics of intravenous (IV) Carbamazepine (CBZ) infusions relative to orally administered CBZ in adult patients with epilepsy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lundbeck LLC
• Treatments: Carbamazepine

Criteria

Inclusion Criteria:

• Patient must be diagnosed with any of the approved epilepsy indications for CBZ that include: Partial seizures with complex symptomatology (psychomotor, temporal lobe); Generalized tonic clonic seizures (grand mal); Mixed seizure patterns that include one of the above; Other partial or generalized seizures.

• Patient must be receiving a stable dose of oral CBZ (tablet or capsule formulation) for a minimum of 14 days prior to Day -28.

• Patient must be receiving a constant dose of all other concomitant medications / device (including AEDs, Vagal Nerve Stimulator (VNS), OTC medications, and herbal supplements) that may not interfere with the metabolism of CBZ for a minimum of 14 days prior to Day -28. No change in baseline AEDs are expected during the treatment period.

• The patient must be able to comply with maintaining an accurate epilepsy medication dosing diary and seizure diary.

• If female: Patient is not of childbearing potential.

• If childbearing potential: Must have a negative serum pregnancy test at Day -28 and a negative serum pregnancy test on Day -1; Must comply with a method of birth control acceptable to the investigator (with the exception of hormone based contraceptives which are contraindicated with the use of CBZ).

Exclusion Criteria:

• Patient is taking a daily oral dose of CBZ greater than 2000 mg per day.

• Patient is being treated with hormone based therapy for birth control.

• Patient has a QTc interval value that is greater than 450 msec.

• Patient has a screening ALT, AST or bilirubin > 3 times the upper limit of normal.

• Patients with CLCR < 30 mL/min or with a renal disorder (i.e. nephrotic syndrome, patients on hemodialysis or peritoneal dialysis or being considered for peritoneal or hemodialysis).

• Patient is receiving oral CBZ for absence seizures.

• Patient has had an episode of status epilepticus within 30 days of screening.

• Patient has a history of severe or serious adverse reactions to CBZ (e.g. aplastic anemia, agranulocytosis).

• Patient has been diagnosed with narrow angle glaucoma.

• Patient weighs less than 50 kg.