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Study transferring to another facility
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | This is the comparator. Placebo will be matched to color, taste, size, and smell. | |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | This is an atypical antipsychotic that blocks dopamine and increase the serotonin level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 minutes |
| Barnes Akathisia Scale |
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Inclusion Criteria:
Subjects can be enrolled in the study only if they meet all of the following criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald Maguire, M.D. | UCIMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine Medical Center | Orange | California | 92868 | United States |
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Measures how restless the subject is during the examination.
| 3 minutes |
| ID | Term |
|---|---|
| D013342 | Stuttering |
| ID | Term |
|---|---|
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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