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

Stuttering Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01684657
• Other study ID #: Asenapine Stuttering
• Status: Suspended
• Phase: Phase 3
• First received: July 24, 2012
• Last updated: May 19, 2014
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 32
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stuttering

Intervention

Drug:
• Asenapine
This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.

Locations

Country	Name	City	State
United States	University of California Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Barnes Akathisia Scale	Measures how restless the subject is during the examination.	3 minutes	Yes