Recruiting
Phase 2
Phase 3

Ecopipam

Sponsor:

Gerald Maguire, MD

Code:

NCT02909088

Conditions

Stuttering, Adult

Childhood-onset Fluency Disorder

Speech Disorders

Language Disorders

Communication Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Ecopipam 50mg

Ecopipam 100mg

Study Details

Brief summary:

The primary objective of this study is to evaluate the efficacy and tolerability of ecopipam in reducing stuttering symptoms.

It is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the SSI-IV total score, the CGI, SSS and OASES.

Conditions

Stuttering, Adult

Childhood-onset Fluency Disorder

Speech Disorders

Language Disorders

Communication Disorder

Study ID

NCT02909088

Start date

Sep, 2016

Status verified date

Oct, 2016

Completion date

Nov, 2017

Anticipated

Primary completion date

Aug, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects can be enrolled in the study only if they meet all of the following criteria:

1. Subjects must satisfy DSM-IV criteria for childhood onset fluency disorder (stuttering).
2. The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
3. Subjects must have a score of moderate or higher on the SSI-IV.
4. Women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device).
5. Subjects will be male or female from the ages of 18-60.
6. Subject must have a MADRS total score of ≤ 13 (normal mood)
7. Subjects will be of only English speaking.

Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

1. Adult individuals who lack capacity to consent for themselves.
2. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).
3. Unstable medical or psychiatric illness.
4. Active substance abuse within three months prior to study inclusion.
5. Any illness that would require the concomitant use of a CNS active medication during the course of the study.
6. Subjects with Parkinson's dementia or other degenerative neurologic illness.
7. Suffer from irregular heart rate or seizures
8. Subjects who are pregnant or nursing an infant.
9. Subject with a MADRS ≥ 14
10. Breastfeeding a child during the course of the study or for one month following completion
11. It is the investigator's opinion that the subject poses a significant suicide risk by the following criteria:

1. It is the investigator's opinion that the subject may be at risk of suicide.
2. the subject responds "yes" to question #4 (Active Suicidal Ideation with Specific Plan and Intent) on the Baseline Visit of the Columbia Suicide Severity Rating Scale (C-SSRS), if the most recent episode occurred within the past 12 months.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ecopipam 50mg

50mg of ecopipam at bedtime for the first two weeks. If there is deemed improvement by the investigator, the subject will remain on the same dose. If there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14.

experimental: Ecopipam 100mg

If there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14.

Interventions

Ecopipam 50mg

Ecopipam 100mg

Primary outcome measure

  • Change in the Stuttering Severity Instrument Version IV (SSI-IV) [ Time Frame: This scale is completed on Visit 1/screening and Visit 5/week 8. ]

Central Contacts and Locations

Locations

CITrials

Recruiting

Riverside, California, United States, 92506

Contacts

Debra M Hoffmeyer, MA

952-300-4924Debra@citrials.com

More Information

Sponsor

Gerald Maguire, MD

Last update posted

Oct 26, 2016

Last verified

Oct, 2016

Keywords

  • stuttering
  • childhood onset fluency disorder
  • ecopipam

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gerald Maguire, MD on 2016-10-26.