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

Speech Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02909088
• Other study ID #: EcoUCR001
• Secondary ID: IND 128278
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 25, 2016
• Last updated: October 24, 2016
• Start date: September 2016
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: CITrials
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood-onset Fluency Disorder
• Communication Disorder
• Communication Disorders
• Disease
• Language Disorders
• Speech Disorders
• Stuttering
• Stuttering, Adult

Intervention

Drug:
• Ecopipam 50mg

• Ecopipam 100mg

Locations

Country	Name	City	State
United States	CITrials	Riverside	California
United States	University of California Riverside School of Medicine	Riverside	California

Sponsors (2)

Lead Sponsor	Collaborator
Gerald Maguire, MD	University of California Riverisde School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (7)

Gilbert DL, Budman CL, Singer HS, Kurlan R, Chipkin RE. A D1 receptor antagonist, ecopipam, for treatment of tics in Tourette syndrome. Clin Neuropharmacol. 2014 Jan-Feb;37(1):26-30. doi: 10.1097/WNF.0000000000000017. — View Citation

Maguire G, Franklin D, Vatakis NG, Morgenshtern E, Denko T, Yaruss JS, Spotts C, Davis L, Davis A, Fox P, Soni P, Blomgren M, Silverman A, Riley G. Exploratory randomized clinical study of pagoclone in persistent developmental stuttering: the EXamining Pa — View Citation

Maguire GA, Riley GD, Franklin DL, Gottschalk LA. Risperidone for the treatment of stuttering. J Clin Psychopharmacol. 2000 Aug;20(4):479-82. — View Citation

Maguire GA, Riley GD, Franklin DL, Maguire ME, Nguyen CT, Brojeni PH. Olanzapine in the treatment of developmental stuttering: a double-blind, placebo-controlled trial. Ann Clin Psychiatry. 2004 Apr-Jun;16(2):63-7. — View Citation

Maguire GA, Riley GD, Yu BP. A neurological basis of stuttering? Lancet Neurol. 2002 Nov;1(7):407. Review. — View Citation

Maguire GA, Yu BP, Franklin DL, Riley GD. Alleviating stuttering with pharmacological interventions. Expert Opin Pharmacother. 2004 Jul;5(7):1565-71. Review. — View Citation

Riley J, Riley G, Maguire G. Subjective Screening of Stuttering severity, locus of control and avoidance: research edition. J Fluency Disord. 2004;29(1):51-62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Stuttering Severity Instrument Version IV (SSI-IV)	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.	This scale is completed on Visit 1/screening and Visit 5/week 8.	No
Secondary	Clinical Global Impression Scale-Severity (CGI-S)	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.	This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, and Visit 5/week 8.	No
Secondary	Subjective Stuttering Scale (SSS)		This scale is completed on Visit 2/baseline and Visit 5/week 8.	No
Secondary	Overall Assessment of the Speaker's Experience of Stuttering (OASES)		This scale is completed on Visit 2/baseline and Visit 5/week 8.	No
Secondary	Montgomery Asberg Depression Rating Scale (MADRS)	An observer-rated depression scale	This scale is completed on Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8.	Yes
Secondary	Barnes Akathisia Scale (BAS)	measures how restless the subject is during the examination	This scale is completed on Visit 1/screening, Visit 5/week 8.	Yes
Secondary	Abnormal Involuntary Movement Scale (AIMS)		This scale is completed on Visit 1/screening, Visit 5/week 8.	Yes
Secondary	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.	Yes
Secondary	Simpson Angus Scale (SAS)		This scale is completed on Visit 1/screening, Visit 5/week 8.	Yes