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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01889602
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women
* Ages 18-50
* Women are post-menopausal or using approved birth control methods
* To control for brain lateralization of language functions, subjects need to have a dominant right hand.
Exclusion Criteria:
* Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, renal, neurologic, and/or psychiatric disease including suicidality
* Vision or hearing impairments
* Current or a history of drug or alcohol abuse
* living outside of the Twin Cities Metropolitan area.
* The use of concomitant medications known to affect Topiramate (TPM), Lorazepam (LZP), or the use of any concomitant medications that may alter cognitive function
* Prior adverse reaction or prior hypersensitivity to TPM, LZP or related compounds
* A positive pregnancy test (administered to all women before enrollment, and prior to each study session).
* Subjects who have received any investigational drug within the previous 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01889602
Study Brief:
Protocol Section:
NCT01889602