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

This study has suspended participant recruitment.
(Study transferring to another facility)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Gerald Maguire, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01684657
First received: July 24, 2012
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Stuttering
Drug: Asenapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Stuttering Severity Instrument [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Measures how restless the subject is during the examination.


Estimated Enrollment: 32
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gerald Maguire, Senior Associate Dean, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01684657     History of Changes
Other Study ID Numbers: Asenapine Stuttering
Study First Received: July 24, 2012
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 19, 2014