EXTENT: EXtended Tolerability and Efficacy of a Novel Formulation of Oxcarbazepine in a Trial in Partial Epilepsy

NCT00391534 | Terminated Phase 3

• 2 other identifiers: OXC-039/KEudraCT No: 2006-003834-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

This study is intended to investigate the safety and efficacy of a novel formulation of oxcarbazepine that is released more slowly than the current formulation. The study medication will be used as a treatment against partial epilepsy.

Conditions

Partial Epilepsy

Keywords

Epilepsy; oxcarbazepine

Outcome Measures

Primary Outcomes (1)

• Maintenance dosage where dose up-titration has to be discontinued due to AEs

  whenever criterion is met

Secondary Outcomes (6)

• Number of seizures during the trial

  Visit 1, Visit 2, Final Visit and each unscheduled visit

• OXC and MHD plasma levels obtained from 6 patients per centre

  Visit 1, Visit 2, Final Visit and each unscheduled visit

• Adverse event profile Plus (AEP) questionnaire-score

  at each patient contact

• EpiTrack

  Visit 1, Visit 2, Final Visit and each unscheduled visit

• Vital Signs and ECG

  Visit 1, Visit 2, Final Visit and each unscheduled visit

Study Arms (2)

Oxcarbazepine MR

EXPERIMENTAL

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC MR. Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

Drug: modified release formulation of oxcarbazepine (OXC MR)

Oxcarbazepine IR

ACTIVE COMPARATOR

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC IR (divided in two daily doses). Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

Drug: immediate release formulation of oxcarbazepine (OXC IR)

Interventions

modified release formulation of oxcarbazepine (OXC MR) DRUG

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC MR. Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

Oxcarbazepine MR

immediate release formulation of oxcarbazepine (OXC IR) DRUG

Patients who are pre-treated with a total daily dose of exactly 900 or exactly 1200 mg or exactly 1500 mg oxcarbazepine (as OXC IR) will increase dosage of OXC by 300 mg to a daily dose of 1200 mg / 1500 mg / 1800 mg OXC IR (divided in two daily doses). Dosage will be titrated to a maximum tolerated total daily dose, maximally to 2700 mg in steps of 300 mg every 6th day.

Oxcarbazepine IR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Symptomatic hyponatremia.
• Pregnancy or breast feeding.
• Participation in drug trials during 3 months preceding the study.

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (6)

Unknown Facility

Bergisch Gladbach, Germany

Location

Unknown Facility

Bonn, Germany

Location

Unknown Facility

Erlangen, Germany

Location

Unknown Facility

Freiburg im Breisgau, Germany

Location

Unknown Facility

Göttingen, Germany

Location

Unknown Facility

Kehl-Kork, Germany

Location

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christian E. Elger, Prof. MD

  Klinik für Epileptologie, Universität Bonn, Bonn, Germany

  PRINCIPAL INVESTIGATOR

• Martina Wangemann, Dr.

  Desitin Arzneimittel GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 23, 2006
• First Posted: October 24, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 15, 2010

Record last verified: 2009-01

Locations

DE (6)