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

Paused · Phase 3

Conditions studied: Stuttering

In brief

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.

Key facts

Study ID

NCT01684657

Run by

University of California, Irvine

People needed

32

Starts

2012-09-01

Expected to finish

2014-05-01

Last updated by the study team

2014-05-20

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects can be enrolled in the study only if they meet all of the following 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).
• Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only English speaking.

You may not qualify if…

• Subjects will be excluded from the study for any of the following reasons:
• Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
• Unstable medical or psychiatric illness.
• 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).

Where it is running

• University of California Irvine Medical Center — Orange, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.