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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2022-04-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering

NCT00830154

Stuttering

COMPLETED PHASE2/PHASE3

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

Stuttering

SUSPENDED PHASE3

EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study

NCT00216255

Persistent Developmental Stuttering

COMPLETED PHASE2

4-Aminopyridine in Episodic Ataxia Type 2

NCT01543750

Episodic Ataxia Type 2

WITHDRAWN PHASE2

Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)

NCT00239915

Persistent Developmental Stuttering

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood-Onset Fluency Disorder (Stuttering)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ecopipam HCl ~2mg/kg/day

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

Group Type EXPERIMENTAL

Ecopipam

Intervention Type DRUG

Oral tablet

Matching Placebo

Matching placebo tablets for daily, oral administration for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ecopipam

Oral tablet

Intervention Type DRUG

Placebo

Oral tablet

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No