Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01281956 : PRX-00023 Therapy in Localization-Related Epilepsy
PhasePhase 2
AgesMin: 18 Years Max: 65 Years
Eligibility
- INCLUSION CRITERIA:

1. Age 18 to 65

2. Localization-related epilepsy diagnosed by standard clinical criteria that has
not responded to treatment with up to two standard antiepileptic drugs either
sequentially or in combination.

3. Patients must be able to provide informed consent.

4. Patients must be able to remain on their baseline AED drugs and doses for the 34
weeks of the study

5. Patients must be able to use seizure calendars to record seizures throughout the
trial.

EXCLUSION CRITERIA:

1. Pregnancy or lactation or women of child-bearing potential who are unable or
unwilling to take adequate contraceptive precautions, including one of the following:

- hormonal contraception (birth control pills, injected hormones or vaginal ring);

- intrauterine device;

- barrier methods (condom or diaphragm) combined with spermicide;

- surgical sterilization (hysterectomy, tubal ligation, or vasectomy in a partner

2. Use of any alcohol or recreational drugs starting two weeks before entering baseline

3. Contraindication to MRI such as presence of prohibited implants, aneurysm clips,
metallic prostheses (including metal pins and rods, heart valves, and cochlear
implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments

4. Current treatment for another significant medical disorder, such as diabetes, or
heart disease, or an untreated disorder, that is discovered during the screening
examination and might interfere with the study

5. Inability to participate in the study procedures, such as MRI, PET, seizure and
adverse event recording, or drug titration

6. An abnormality on clinical laboratory tests, physical examination, EEG or ECG that
might increase the risk associated with trial participation or investigational
product administration, such as hepatic enzyme elevation greater than twice normal,
or hematocrit lower than 30.

7. A level 4 or 5 on the Columbia Suicide Severity Rating Scale rating for symptoms
during the last three months

8. Concomitant treatment with more than 2 AEDs

9. Evidence for a potentially progressive neurologic disorder, such as an astrocytoma

10. Use of sublingual lorazepam for seizure clusters more than once per wee

11. Use of any of the following prohibited medications/classes with less than required
interval period:

- Any other Investigational drugs; required interval period (weeks prior to
baseline) is 4

- benzodiazepines; required interval period (weeks prior to baseline) is 4

- MAO Inhibitors anti depressant; required interval period (weeks prior to
baseline) is 4

- Buspirone; required interval period (weeks prior to baseline) is 2

- Fluvoxamine; required interval period (weeks prior to baseline) is 2

- Citalopram; required interval period (weeks prior to baseline) is 2

- Paroxetine; required interval period (weeks prior to baseline) is 2

- Sertraline; required interval period (weeks prior to baseline) is 2

- buproprion; required interval period (weeks prior to baseline) is 2

- Mirtazepine; required interval period (weeks prior to baseline) is 2

- Nefazodone; required interval period (weeks prior to baseline) is 2

- Venlafaxine; required interval period (weeks prior to baseline) is 2

- Duloxetine; required interval period (weeks prior to baseline) is 2

- Trazodone; required interval period (weeks prior to baseline) is 2

- tricyclic and heterocyclic antidepressants; required interval period (weeks
prior to baseline) is 2

- other psychotropic medicines; required interval period (weeks prior to baseline)
is 2

- potent CYP3A4 inducers/inhibitors; required interval period (weeks prior to
baseline) is 2 for:

- Itraconazole

- ketoconazole

- HIV antivirals

- clarithromycin

- phenytoin
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01281956      |      Link to official Clinicaltrials.gov listing
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