Clinical trial NCT00391534 (phase 3, status: terminated)
Conditions: partial epilepsy
ICD codes: G40.111, G40.119, G40.211, G40.219, G40.101, G40.109, G40.201
Drugs: modified release formulation of oxcarbazepine (oxc mr), immediate release formulation of oxcarbazepine (oxc ir)
SMILES: NC(=O)N1C2=CC=CC=C2CC(=O)C2=C1C=CC=C2, NC(=O)N1C2=CC=CC=C2CC(=O)C2=C1C=CC=C2
Reason stopped: 
    low recruitment rate
  
Eligibility criteria:

        Inclusion Criteria:

          -  Female and male patients with minimal age of 18 years on the date of the first study
             visit.

          -  Stable treatment with Oxcarbazepine treatment (Timox® /Trileptal®), dosage: exactly
             900 mg or exactly 1200 mg or exactly 1500 mg for at least 1 month prior to screening.

          -  >= 2 partial onset seizures with or without secondary generalisation refractory to
             existing AED therapy within the baseline period.

          -  Weight between >= 50 kg and < 100 kg.

          -  for females with child-bearing potential: negative pregnancy rest and highly effective
             form of birth control (females using hormonal contraceptives should use a different or
             additional means of birth control, e.g. IUD, abstinence, vasectomized partner, double
             barriere methods with or without oral contraceptives)

          -  Stable regimen of <= 2 concomitant AEDs (vagus nerve stimulator included) during the
             baseline period; lamotrigine dose may be adjusted at baseline.

          -  Ethnic origin: Caucasian.

          -  Subjects capable of complying with the study stipulations.

          -  Patients who have provided written informed consent to participate in this study.

        Exclusion Criteria:

          -  Epilepsy secondary to progressive metabolic disease, malignant neoplasm, substance
             abuse, or active infection.

          -  Status epilepticus at any time during the baseline period.

          -  Lennox-Gastaut syndrome.

          -  Generalized epilepsy as primary diagnosis.

          -  Severe cardiac, pulmonary, haematological, hepatic, renal or neoplastic pathology.

          -  Acute medical conditions and/or conditions that could interfere with the absorption,
             metabolism or excretion of oxcarbazepine.

          -  History of clinically relevant psychiatric illness and/or drug abuse, drug addiction
             or alcoholism within the last 2 years.

          -  Treatment with psychotropic drugs, anticholinergic drugs, anti-parkinson medication,
             α1-antagonists, α2-antagonists, carbamazepine, topiramate, felbamate, vigabatrin.
             Stable treatment with selective serotonin-reuptake-inhibitor (SSRI) having been given
             for at least 4 weeks prior to screening as supportive treatment of partial epilepsy
             can be accepted.

          -  Intake of sodium lowering medication, e.g. diuretics and non-steroidal anti-
             inflammatory drugs. Occasional and short-term intake of non-steroidal anti-
             inflammatory drugs on demand (Ibuprofen, Paracetamol, ASS, Diclofenac and others) is
             allowed.

          -  Hypersensitivity towards oxcarbazepine or chemically related drugs.

          -  Low sodium serum levels (< 128 mmol/L). Sodium serum levels ≥ 126 and < 128 mmol/L can
             be accepted for inclusion, if these levels have been stable for at least 3 months.

          -  Symptomatic hyponatremia.

          -  Pregnancy or breast feeding.

          -  Participation in drug trials during 3 months preceding the study.