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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT01684657
Eligibility Criteria:
Inclusion Criteria:
Subjects can be enrolled in the study only if they meet all of the following criteria:
1. Subjects must satisfy DSM-IV criteria for stuttering.
2. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
3. Subjects must have a score of moderate or higher on the SSI-IV. 4) Women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device).
5)Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only English speaking.
Exclusion Criteria:
Subjects will be excluded from the study for any of the following reasons:
1. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
2. Unstable medical or psychiatric illness.
3. Active substance abuse within three months prior to study inclusion.
4. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
5. Subjects with Parkinson's dementia or other degenerative neurologic illness.
6. Subjects who are pregnant or nursing an infant.
7. No minors (under the age of 18) will not be enrolled in this study as the research with this compound in children and adolescents has not been fully performed.
8. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01684657
Study Brief:
Protocol Section:
NCT01684657