A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine Wit… (NCT01684657) | Clinical Trial Compass
SuspendedPhase 3
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
Stopped: Study transferring to another facility
United States32 participantsStarted 2012-09
Plain-language summary
The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.
It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects must satisfy DSM-IV criteria for stuttering.
. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
. 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).
Exclusion criteria
. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
. Unstable medical or psychiatric illness.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Active substance abuse within three months prior to study inclusion.
. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
. Subjects with Parkinson's dementia or other degenerative neurologic illness.
. Subjects who are pregnant or nursing an infant.
. 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.
. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).