NCT01684657SuspendedPhase 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
University of California, Irvine1 site in 1 country32 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Suspended
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Stuttering Severity Instrument
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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-
- •Subjects will be of only English speaking.
Exclusion Criteria
- •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).
Arms & Interventions
Asenapine
Experimental
This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study.
Intervention: Asenapine (Drug)
Outcomes
Primary Outcomes
Stuttering Severity Instrument
Time Frame: 10 minutes
This is an objective measure of stuttering in which it captures verbal samples of five minutes speaking during a conversation and 5 minutes of reading a passage.
Secondary Outcomes
- Barnes Akathisia Scale(3 minutes)
- Clinical Global Impression(2 minutes)
Investigators
Gerald Maguire
Senior Associate Dean
University of California, Irvine
Study Sites (1)
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