Back to resultsA Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
Primary Purpose
Stuttering
Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Asenapine
Sponsored by
About this trial
This is an interventional treatment trial for Stuttering focused on measuring Stuttering
Eligibility Criteria
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).
5)Subjects will be male or female from the ages of 18-70. 6)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).
Sites / Locations
- University of California Irvine Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Asenapine
Arm Description
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.
Outcomes
Primary Outcome Measures
Stuttering Severity Instrument
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 Outcome Measures
Clinical Global Impression
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
Measures how restless the subject is during the examination.
Full Information
NCT ID
NCT01684657
First Posted
July 24, 2012
Last Updated
May 19, 2014
Sponsor
University of California, Irvine
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01684657
Brief 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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Suspended
Why Stopped
Study transferring to another facility
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stuttering
Keywords
Stuttering
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This is the comparator. Placebo will be matched to color, taste, size, and smell.
Arm Title
Asenapine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Asenapine
Other Intervention Name(s)
Saphris
Intervention Description
This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.
Primary Outcome Measure Information:
Title
Stuttering Severity Instrument
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Clinical Global Impression
Description
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.
Time Frame
2 minutes
Title
Barnes Akathisia Scale
Description
Measures how restless the subject is during the examination.
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
5)Subjects will be male or female from the ages of 18-70. 6)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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Maguire, M.D.
Organizational Affiliation
UCIMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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