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

Sponsor

Gerald Maguire, MD (Other)

Overall Status

Unknown status

CT.gov ID

NCT02909088

Collaborator

University of California Riverisde School of Medicine (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stuttering, Adult Childhood-onset Fluency Disorder Speech Disorders Language Disorders Communication Disorder	Drug: Ecopipam 50mg Drug: Ecopipam 100mg	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Study to Evaluate the Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2017

Anticipated Study Completion Date :

Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Ecopipam 50mg Drug: Ecopipam 100mg
Experimental: Ecopipam 100mg If there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14.	Drug: Ecopipam 50mg Drug: Ecopipam 100mg

Arm

Intervention/Treatment

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.

Drug: Ecopipam 50mg

Drug: Ecopipam 100mg

Experimental: Ecopipam 100mg

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

Drug: Ecopipam 50mg

Drug: Ecopipam 100mg

Outcome Measures

Primary Outcome Measures

Change in the Stuttering Severity Instrument Version IV (SSI-IV) [This scale is completed on Visit 1/screening and Visit 5/week 8.]
This is an objective measure of stuttering in which it captures verbal samples of five minutes speaking during a conversation and 5 minutes of reading a passage.

Secondary Outcome Measures

Clinical Global Impression Scale-Severity (CGI-S) [This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, and Visit 5/week 8.]
This is an evaluation of the patient by the investigator as to whether or not the subjects has improved, remained the same, or worsened while in the study.
Subjective Stuttering Scale (SSS) [This scale is completed on Visit 2/baseline and Visit 5/week 8.]
Overall Assessment of the Speaker's Experience of Stuttering (OASES) [This scale is completed on Visit 2/baseline and Visit 5/week 8.]
Montgomery Asberg Depression Rating Scale (MADRS) [This scale is completed on Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8.]
An observer-rated depression scale
Barnes Akathisia Scale (BAS) [This scale is completed on Visit 1/screening, Visit 5/week 8.]
measures how restless the subject is during the examination
Abnormal Involuntary Movement Scale (AIMS) [This scale is completed on Visit 1/screening, Visit 5/week 8.]
Columbia-Suicide Severity Rating Scale (C-SSRS) [This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8.]
Simpson Angus Scale (SAS) [This scale is completed on Visit 1/screening, Visit 5/week 8.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Subjects must satisfy DSM-IV criteria for childhood onset fluency disorder (stuttering).
The nature of stuttering must be developmental in origin with the onset prior to ten years of age.
Subjects must have a score of moderate or higher on the SSI-IV.
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).
Subjects will be male or female from the ages of 18-60.
Subject must have a MADRS total score of ≤ 13 (normal mood)
Subjects will be of only English speaking.

Exclusion Criteria:

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

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