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

NCT04492956 | Completed Phase 2 FDA Drug

• 1 other identifier: EBS-101-COFD-201
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Childhood-Onset Fluency Disorder (Stuttering)

Keywords

Stuttering; Communication Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12

  Measures stuttering severity in children and adults

  12 weeks

Secondary Outcomes (1)

• Clinical Global Impression - Severity (CGI-S) baseline to Week 12

  12 weeks

Study Arms (2)

Ecopipam HCl ~2mg/kg/day

EXPERIMENTAL

Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks

Drug: Ecopipam

Matching Placebo

PLACEBO COMPARATOR

Matching placebo tablets for daily, oral administration for 12 weeks

Drug: Placebo

Interventions

Ecopipam DRUG

Oral tablet

Ecopipam HCl ~2mg/kg/day

Placebo DRUG

Oral tablet

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emalex Biosciences Inc.: lead
• University of California, Riverside: collaborator
• Premier Research: collaborator

Study Sites (9)

UC Riverside

Riverside, California, 92501, United States

Location

CI Trials

Santa Ana, California, 92705, United States

Location

Clinical Neuroscience Solutions Inc

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions Inc

Orlando, Florida, 32801, United States

Location

Institute For Advanced Medical Research

Atlanta, Georgia, 30341, United States

Location

Social Psychiatry Research Institute

Prairie Village, Kansas, 66208, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Social Psychiatry Research Institute

Brooklyn, New York, 11235, United States

Location

Clinical Neuroscience Solutions Inc

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Childhood-Onset Fluency Disorder; Stuttering; Communication Disorders

Interventions

ecopipam

Condition Hierarchy (Ancestors)

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

Study Officials

• Atul R Mahableshwarkar, MD, DFAPA

  Emalex Biosciences Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: October 2, 2020
• Primary Completion: March 7, 2022
• Study Completion: April 4, 2022
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)