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

NCT02909088 | Unknown Phase 2

• 2 other identifiers: EcoUCR001IND 128278
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

stuttering; childhood onset fluency disorder; ecopipam

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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.

• 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.

• Barnes Akathisia Scale (BAS)

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

Study Arms (2)

Ecopipam 50mg

EXPERIMENTAL

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

Ecopipam 100mg

EXPERIMENTAL

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

Interventions

Ecopipam 50mg DRUG

Ecopipam 100mg; Ecopipam 50mg

Ecopipam 100mg DRUG

Ecopipam 100mg; Ecopipam 50mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gerald Maguire, MD: lead
• University of California Riverisde School of Medicine: collaborator

Study Sites (2)

CITrials

Riverside, California, 92506, United States

RECRUITING

University of California Riverside School of Medicine

Riverside, California, 92521, United States

NOT YET RECRUITING

Related Publications (7)

• 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.

  PMID: 15328899 RESULT

• 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.

  PMID: 15212606 RESULT

• 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.

  PMID: 20075648 RESULT

• 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.

  PMID: 12849360 RESULT

• 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.

  PMID: 24434529 RESULT

• 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.

  PMID: 15026214 RESULT

• 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.

  PMID: 10917410 RESULT

MeSH Terms

Conditions

Stuttering; Childhood-Onset Fluency Disorder; Speech Disorders; Language Disorders; Communication Disorders

Interventions

ecopipam

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair, Psychiatry and Neuroscience, Principal Investigator

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (2)