Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).

Gerald Maguire, MD

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Childhood-onset Fluency Disorder; Communication Disorder; Stuttering, Adult; Language Disorders; Speech Disorders

Treatments: Drug: Ecopipam 50mg; Drug: Ecopipam 100mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02909088

IND 128278 (Registry Identifier)

EcoUCR001

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Ecopipam 50mg

Experimental group

Description:

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.

Treatment:

Drug: Ecopipam 50mg

Drug: Ecopipam 100mg

Ecopipam 100mg

Experimental group

Description:

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

Treatment:

Drug: Ecopipam 50mg

Drug: Ecopipam 100mg