An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Phenobarbital as Adjunctive Therapy in Participants (> or = 17 to 70 Years Old) With Partial Onset Seizures
| City: |
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Lexington |
| State: |
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Kentucky |
| Zip Code: |
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40504 |
| Conditions: |
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Epilepsy |
| Purpose: |
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Primary:
- to evaluate the efficacy of phenobarbital in reducing seizure frequency.
Secondary:
- to confirm dose response relationship,
- to assess the effects on Type I seizures,
- to assess the safety of phenobarbital
- to assess the drug tolerability.
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| Study Summary: |
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Primary:
-to evaluate the efficacy of once daily (OD) administration of 60 mg and 100 mg
phenobarbital, in reducing seizure frequency in participants with partial onset seizures
(Type I seizures; complex or simple with motor symptoms only) not fully controlled despite
treatment with 1 to 3 concomitant anti-epileptic drugs (AEDs) or AEDs with Vagus Nerve
Stimulator (VNS)
Secondary:
- to confirm dose response relationship of 60 and 100 mg phenobarbital doses,
- to assess the effects of phenobarbital on Type I seizures,
- to assess the safety of phenobarbital
- to assess the tolerability of phenobarbital
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| Criteria: |
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Inclusion Criteria:
- participants from 17 to 70 years old;
- history of Type I partial onset seizures (complex or simple with motor symptoms
only);
- participants must have had electroencephalogram (EEG), magnetic resonance imaging
(MRI) or computed tomography (CT) with results consistent with diagnosis of
partial-onset seizures;
- participants having at least eight Type I partial onset seizures during 8-week
baseline period;
- participants being uncontrolled while treated by 1 to 3 permitted concomitant
anti-epileptic drug (AED) and/or Vagus Nerve Stimulation (VNS);
- participant has been on a stable dose of their current anti-epileptic treatment
regime
Exclusion Criteria:
- currently taking phenobarbital or primidone;
- currently taking felbamate or vigabatrin;
- history of prior allergic reaction to phenobarbital;
- history of psychogenic seizures;
- history or presence of status epilepticus;
- history or presence of seizures occurring only in clusters;
- participant taking any drug with possible Central Nervous System (CNS) effects except
if stable from 1 month prior Visit 1;
- history of cerebrovascular accident (CVA) or transient ischemic attack (TIA);
- presence of any sign suggesting rapidly progressing brain disorder or brain tumor;
- presence of unstable arteriovenous malformations, meningiomas or other benign tumors;
- history of porphyria;
- presence of clinically significant findings on physical exam, vital signs,
electrocardiogram (ECG) or safety lab assessments, including renal or hepatic
insufficiency;
- history of alcohol or drug abuse within the year prior to screening;
- participant who is known to be non-compliant;
- participant who is male or female who refuses to use an acceptable form of
contraception;
- female who is pregnant or lactating or intends to become pregnant;
- participant who has taken part in any investigational device or product within 2
months prior to the screening visit
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| NCT ID: |
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NCT01284556 |
| Primary Contact: |
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N/A |
| Backup Contact: |
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N/A |
| Location Contact: |
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Lexington, Kentucky 40504
United States
Amber Chumley
Phone: 859-313-4989
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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