Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely)

Childhood-Onset Fluency Disorder (Stuttering) Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Exploratory Study to Evaluate the Efficacy and Safety of Ecopipam Tablets in Adults With Childhood Onset Fluency Disorder (Stuttering)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492956
• Other study ID #: EBS-101-COFD-201
• Status: Completed
• Phase: Phase 2
• Start date: October 2, 2020
• Est. completion date: April 4, 2022

Study information

• Verified date: April 2022
• Source: Emalex Biosciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.

Description:

At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl ~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.

Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study.

At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 4, 2022
• Est. primary completion date: March 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to read and write in English and provide informed consent

• 18 years or older of age at screening

• Weighs >= 45 kg (~99 lbs)

• Satisfies DSM-5 criteria for childhood onset fluency disorder

• History of stuttering for >=2 years with onset consistent to developmental in nature

• Must meet an allowed severity of stuttering at screening and baseline, scored by a central rater

• Completed an adequate course of speech therapy

• Has a qualifying IOS or Android smartphone

• Must discontinue all medications used to treat stuttering for at least 14 days prior to screening

• Sexually active females of child bearing potential must be using effective contraception during and 30 days after participation

• Sexually active males must use a double barrier method of contraception during and 30 days after participation

Exclusion Criteria:

• Stuttering is related to a known neurological cause

• Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline

• Unstable medical illness or clinically significant abnormalities on screening tests/exams

• At a significant risk of committing suicide

• Are pregnant or lactating

• Positive urine drug screen

• Lifetime history of major depressive episode

• History of seizures

• Have been previously treated with ecopipam

• Unstable use of medications prior to screening

• Use of prohibited medications or need for medications which would have unfavorable interactions with ecopipam

• Not suitable for study in the opinion of the Principle Investigator

Related Conditions & MeSH terms

• Childhood-Onset Fluency Disorder
• Childhood-Onset Fluency Disorder (Stuttering)
• Stuttering

Intervention

Drug:
• Ecopipam
Oral tablet
• Placebo
Oral tablet

Locations

Country	Name	City	State
United States	Institute For Advanced Medical Research	Atlanta	Georgia
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Michigan State University	East Lansing	Michigan
United States	Clinical Neuroscience Solutions Inc	Jacksonville	Florida
United States	Clinical Neuroscience Solutions Inc	Memphis	Tennessee
United States	Clinical Neuroscience Solutions Inc	Orlando	Florida
United States	Social Psychiatry Research Institute	Prairie Village	Kansas
United States	UC Riverside	Riverside	California
United States	CI Trials	Santa Ana	California

Sponsors (3)

Lead Sponsor	Collaborator
Emalex Biosciences Inc.	Premier Research Group plc, University of California, Riverside

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12	Measures stuttering severity in children and adults	12 weeks
Secondary	Clinical Global Impression - Severity (CGI-S) baseline to Week 12	Rates the severity of the subject's illness at the time of assessment, relative to the the clinician's past experience with patients who have the same diagnosis.	12 weeks