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 range18 Years – 70 Years
SexALL
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Inclusion criteria
âś“. Subjects must satisfy DSM-IV criteria for stuttering.
âś“. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
âś“. 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
âś•. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
âś•. Unstable medical or psychiatric illness.
âś•. Active substance abuse within three months prior to study inclusion.
âś•. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
âś•. Subjects with Parkinson's dementia or other degenerative neurologic illness.
âś•. 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.
âś•. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).