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
|ClinicalTrials.gov Identifier: NCT01684657|
Recruitment Status : Suspended (Study transferring to another facility)
First Posted : September 13, 2012
Last Update Posted : May 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Stuttering||Drug: Asenapine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2014|
Placebo Comparator: Placebo
This is the comparator. Placebo will be matched to color, taste, size, and smell.
This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study.
This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.
Other Name: Saphris
- 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.
- Clinical Global Impression [ Time Frame: 2 minutes ]This is an evaluation of the patient by the investigator as to whether or not the subjects has improved, remained the same, or worsened while in the study.
- Barnes Akathisia Scale [ Time Frame: 3 minutes ]Measures how restless the subject is during the examination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684657
|United States, California|
|University of California Irvine Medical Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Gerald Maguire, M.D.||UCIMC|