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

NCT01684657 | Suspended Phase 3 DMC

• 1 other identifier: Asenapine Stuttering
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Stuttering

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Clinical Global Impression

  2 minutes

• Barnes Akathisia Scale

  3 minutes

Study Arms (2)

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.

Drug: Asenapine

Interventions

Asenapine DRUG

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

Also known as: Saphris

Asenapine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects can be enrolled in the study only if they meet all of the following criteria:
• Subjects must satisfy DSM-IV criteria for stuttering.
• The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
• 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).
• )Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only English speaking.

You may not qualify if:

• Subjects will be excluded from the study for any of the following reasons:
• Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
• Unstable medical or psychiatric illness.
• Any illness that would require the concomitant use of a CNS active medication during the course of the study.
• Subjects with Parkinson's dementia or other degenerative neurologic illness.
• Subjects who are pregnant or nursing an infant.
• 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.
• Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).

Sponsors & Collaborators

• University of California, Irvine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Stuttering

Interventions

asenapine

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerald Maguire, M.D.

  UCIMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Dean

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: September 13, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

US (1)