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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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ClinicalTrials.gov Identifier: NCT01684657
Recruitment Status : Suspended (Study transferring to another facility)
First Posted : September 13, 2012
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Stuttering Drug: Asenapine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
This is the comparator. Placebo will be matched to color, taste, size, and smell.
Experimental: Asenapine
This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study.
Drug: Asenapine
This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.
Other Name: Saphris


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Barnes Akathisia Scale [ Time Frame: 3 minutes ]
    Measures how restless the subject is during the examination.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects can be enrolled in the study only if they meet all of the following criteria:

  1. Subjects must satisfy DSM-IV criteria for stuttering.
  2. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
  3. 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:

  1. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
  2. Unstable medical or psychiatric illness.
  3. Active substance abuse within three months prior to study inclusion.
  4. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
  5. Subjects with Parkinson's dementia or other degenerative neurologic illness.
  6. Subjects who are pregnant or nursing an infant.
  7. 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.
  8. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684657


Locations
United States, California
University of California Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Gerald Maguire, M.D. UCIMC
More Information

Responsible Party: Gerald Maguire, Senior Associate Dean, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01684657     History of Changes
Other Study ID Numbers: Asenapine Stuttering
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Keywords provided by Gerald Maguire, University of California, Irvine:
Stuttering

Additional relevant MeSH terms:
Stuttering
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs