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

Emalex Biosciences

Status and phase

Completed

Phase 2

Conditions

Childhood-Onset Fluency Disorder (Stuttering)

Treatments

Drug: Placebo

Drug: Ecopipam

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04492956

EBS-101-COFD-201

Details and patient eligibility

About

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

Full 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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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