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

Primary Purpose

Stuttering, Adult, Childhood-onset Fluency Disorder, Speech Disorders

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ecopipam 50mg

Ecopipam 100mg

About this trial

This is an interventional treatment trial for Stuttering, Adult focused on measuring stuttering, childhood onset fluency disorder, ecopipam

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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:
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.

Sites / Locations

CITrialsRecruiting
University of California Riverside School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ecopipam 50mg

Ecopipam 100mg

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Subjective Stuttering Scale (SSS)

Overall Assessment of the Speaker's Experience of Stuttering (OASES)

Montgomery Asberg Depression Rating Scale (MADRS)

An observer-rated depression scale

Barnes Akathisia Scale (BAS)

measures how restless the subject is during the examination

Abnormal Involuntary Movement Scale (AIMS)

Columbia-Suicide Severity Rating Scale (C-SSRS)

Simpson Angus Scale (SAS)

Full Information

NCT ID

NCT02909088

First Posted

August 25, 2016

Last Updated

October 24, 2016

Sponsor

Gerald Maguire, MD

Collaborators

University of California Riverisde School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02909088

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gerald Maguire, MD

Collaborators

University of California Riverisde School of Medicine

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

stuttering, childhood onset fluency disorder, ecopipam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ecopipam 50mg

Arm Type

Experimental

Arm Description

Arm Title

Ecopipam 100mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ecopipam 50mg

Intervention Type

Drug

Intervention Name(s)

Ecopipam 100mg

Primary Outcome Measure Information:

Title

Change in the Stuttering Severity Instrument Version IV (SSI-IV)

Description

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.

Time Frame

This scale is completed on Visit 1/screening and Visit 5/week 8.

Secondary Outcome Measure Information:

Title

Clinical Global Impression Scale-Severity (CGI-S)

Description

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.

Time Frame

This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, and Visit 5/week 8.

Title

Subjective Stuttering Scale (SSS)

Time Frame

This scale is completed on Visit 2/baseline and Visit 5/week 8.

Title

Overall Assessment of the Speaker's Experience of Stuttering (OASES)

Time Frame

This scale is completed on Visit 2/baseline and Visit 5/week 8.

Title

Montgomery Asberg Depression Rating Scale (MADRS)

Description

An observer-rated depression scale

Time Frame

This scale is completed on Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8.

Title

Barnes Akathisia Scale (BAS)

Description

measures how restless the subject is during the examination

Time Frame

This scale is completed on Visit 1/screening, Visit 5/week 8.

Title

Abnormal Involuntary Movement Scale (AIMS)

Time Frame

This scale is completed on Visit 1/screening, Visit 5/week 8.

Title

Columbia-Suicide Severity Rating Scale (C-SSRS)

Time Frame

This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, Visit 4/week 4 and Visit 5/week 8.

Title

Simpson Angus Scale (SAS)

Time Frame

This scale is completed on Visit 1/screening, Visit 5/week 8.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

CITrials

City

Riverside

State/Province

California

ZIP/Postal Code

92506

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Debra M Hoffmeyer, MA

Phone

952-300-4924

Debra@citrials.com

Facility Name

University of California Riverside School of Medicine

City

Riverside

State/Province

California

ZIP/Postal Code

92521

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gerald A Maguire, MD

Gerald.Maguire@medsch.ucr.edu

First Name & Middle Initial & Last Name & Degree

David L Franklin, PsyD

David.Franklin@medsch.ucr.edu

First Name & Middle Initial & Last Name & Degree

Gerald Maguire, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

15328899

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. doi: 10.1080/10401230490452834.

Results Reference

result

PubMed Identifier

15212606

Citation

Maguire GA, Yu BP, Franklin DL, Riley GD. Alleviating stuttering with pharmacological interventions. Expert Opin Pharmacother. 2004 Jul;5(7):1565-71. doi: 10.1517/14656566.5.7.1565.

Results Reference

result

PubMed Identifier

20075648

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 Pagoclone for peRsistent dEvelopmental Stuttering Study. J Clin Psychopharmacol. 2010 Feb;30(1):48-56. doi: 10.1097/JCP.0b013e3181caebbe.

Results Reference

result

PubMed Identifier

12849360

Citation

Maguire GA, Riley GD, Yu BP. A neurological basis of stuttering? Lancet Neurol. 2002 Nov;1(7):407. doi: 10.1016/s1474-4422(02)00217-x. No abstract available.

Results Reference

result

PubMed Identifier

24434529

Citation

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.

Results Reference

result

PubMed Identifier

15026214

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. doi: 10.1016/j.jfludis.2003.12.001.

Results Reference

result

PubMed Identifier

10917410

Citation

Maguire GA, Riley GD, Franklin DL, Gottschalk LA. Risperidone for the treatment of stuttering. J Clin Psychopharmacol. 2000 Aug;20(4):479-82. doi: 10.1097/00004714-200008000-00013.

Results Reference

result

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

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