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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

NCT01684657 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-05-20

No results posted yet for this study

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

Interventions

DRUG

Asenapine

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

Sponsors & Collaborators

Principal Investigators

  • Gerald Maguire, M.D. · UCIMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684657 on ClinicalTrials.gov