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

NCT ID: NCT01684657

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-05-31

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.

Conditions

Stuttering

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

This is the comparator. Placebo will be matched to color, taste, size, and smell.

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.

Interventions

Asenapine

This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.

Intervention Type: DRUG

Other Intervention Names

Saphris

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Gerald Maguire

Senior Associate Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerald Maguire, M.D.

Role: PRINCIPAL_INVESTIGATOR

UCIMC

Locations

University of California Irvine Medical Center

Orange, California, United States

Countries

United States

Other Identifiers

Asenapine Stuttering

Identifier Type: -

Identifier Source: org_study_id