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

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

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.

Study Overview

• Status: Unknown
• Conditions: Language Disorders; Speech Disorders; Communication Disorder; Stuttering, Adult; Childhood-onset Fluency Disorder
• Intervention / Treatment: Drug: Ecopipam 50mg; Drug: Ecopipam 100mg

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92506
      • Recruiting
      • CiTrials
      • Contact: Debra M Hoffmeyer, MA; Phone Number: 952-300-4924; Email: Debra@citrials.com
    • Riverside, California, United States, 92521
      • Not yet recruiting
      • University of California Riverside School of Medicine
      • Contact: Gerald A Maguire, MD; Email: Gerald.Maguire@medsch.ucr.edu
      • Contact: David L Franklin, PsyD; Email: David.Franklin@medsch.ucr.edu
      • Principal Investigator: Gerald Maguire, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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)	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.
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.
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.

Collaborators and Investigators

• Sponsor: Gerald Maguire, MD
• Collaborators: University of California Riverisde School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: stuttering; childhood onset fluency disorder; ecopipam
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Disease; Language Disorders; Stuttering; Speech Disorders; Communication Disorders; Childhood-Onset Fluency Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Ecopipam
• Other Study ID Numbers: EcoUCR001; IND 128278 (Registry Identifier: FDA)