Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT01284556
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
17 Years
Maximum Age:
70 Years
Study:
NCT01284556
Study Brief:
Protocol Section:
NCT01284556