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Partial EpilepsyPhase 3NCT00391534

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

A Phase 3 study testing modified release formulation of oxcarbazepine (OXC MR) and immediate release formulation of oxcarbazepine (OXC IR) in people with Partial Epilepsy, run by Desitin Arzneimittel GmbH at 6 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Partial Epilepsy
What is being tested?
modified release formulation of oxcarbazepine (OXC MR) and immediate release formulation of oxcarbazepine (OXC IR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesGermany
Study dates
Oct 2006to Nov 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • Ethnic origin: Caucasian.
  • Subjects capable of complying with the study stipulations.
  • Patients who have provided written informed consent to participate in this study.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Study site

    Bergisch Gladbach

  • Study site

    Bonn

  • Study site

    Erlangen

  • Study site

    Freiburg im Breisgau

  • Study site

    Göttingen

  • Study site

    Kehl-Kork

Other trials in Germany

About this study

Official title: Safety and Efficacy of a Novel Modified Release Formulation of Oxcarbazepine (OXC MR) vs an Immediate Release Oxcarbazepine (OXC IR) Product in Patients With Partial Epilepsy

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.

Read the detailed description

This is a multi-centre, randomized, open-label, flexible-titration, controlled, parallel-group study to investigate the safety and efficacy of a novel modified release formulation of oxcarbazepine (OXC MR) compared to an immediate release oxcarbazepine (OXC IR) product in patients with partial epilepsy. Adult patients of both gender, aged at least 18 years with refractory partial epilepsy, with or without secondary generalisation receiving a stable background treatment with daily dosages of exactly 900 or 1200 or 1500 mg Oxcarbazepine will be enrolled. Concomitant medication consisting of maximal 2 additional AEDs (vagus nerve stimulator included) is allowed and must be kept stable throughout the study. Patients, who agree to participate, will first sign and date the informed consent and undergo an evaluation at screening visit to determine eligibility. Those patients who qualify will be enrolled in the study, assigned a patient ID, and will enter the 4-week baseline period. Each patient will receive a seizure diary to record the number of seizures during the baseline period. For Visit 1 the patient will return to the clinic and complete all baseline procedures. Patients who have met the entry criteria will be randomised. The two treatment groups consist of 50 patients each, one group to be treated with OXC MR b.i.d. and the other to be treated with OXC IR b.i.d. in a 1:1 randomization. Following assignment to one of both treatment groups the patient will enter the dose-titration phase. From Visit 1 (Study Day 1) a total daily dose of 1200 mg /1500 mg /1800 mg oxcarbazepine will be given to the randomised patients. From Day 6 the dosage will be titrated to a maximum total daily dose of 2700 mg in steps of 300 mg every 6th day. Patients who experienced intolerable adverse events could reduce their daily dose by 150 mg on the 2nd day of up-titration for the remainder of the treatment period. In case the reduced dosage will also not be tolerated, in a second step the dosage can be reduced by further 150 mg OXC. The maximal tolerated dose achieved on up-titration will be maintained up to the final visit (Study Day 26).

Being tested
modified release formulation of oxcarbazepine (OXC MR), immediate release formulation of oxcarbazepine (OXC IR)
Keywords
Epilepsy, oxcarbazepine
Medical subject headings
Epilepsies, Partial, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT00391534
Study groupRoleWhat they receive
Oxcarbazepine MRExperimentalPatients 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.
Receives: Drug: modified release formulation of oxcarbazepine (OXC MR)
Oxcarbazepine IRActive comparatorPatients 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.
Receives: Drug: immediate release formulation of oxcarbazepine (OXC IR)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: whenever criterion is met

Secondary outcomes (6)

  1. Number of seizures during the trial

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

  2. OXC and MHD plasma levels obtained from 6 patients per centre

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

  3. Adverse event profile Plus (AEP) questionnaire-score

    Measured: at each patient contact

  4. EpiTrack

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

  5. Vital Signs and ECG

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

  6. Laboratory parameters (hematology, serum chemistry, coagulation, urinalysis)

    Measured: Visit 1, Visit 2, Final Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionNov 2009
  4. Study completionNov 2009

Why it stopped: Low recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00391534
Sponsor's protocol ID
OXC-039/K
Other IDs
EudraCT No: 2006-003834-14
Status last verified
Jan 2009
First submitted
23 Oct 2006
Last updated
15 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing modified release formulation of oxcarbazepine (OXC MR) and immediate release formulation of oxcarbazepine (OXC IR) in people with Partial Epilepsy, run by Desitin Arzneimittel GmbH at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maintenance dosage where dose up-titration has to be discontinued due to AEs (time frame: whenever criterion is met). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00391534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2010.

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