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Trial record 5 of 6 for:    Recruiting, Not yet recruiting, Available Studies | "Stuttering"

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

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ClinicalTrials.gov Identifier: NCT02909088
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
University of California Riverisde School of Medicine
Information provided by (Responsible Party):
Gerald Maguire, MD, CITrials

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering

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



Primary Outcome Measures :
  1. Change in the Stuttering Severity Instrument Version IV (SSI-IV) [ Time Frame: 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 :
  1. Clinical Global Impression Scale-Severity (CGI-S) [ Time Frame: 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.

  2. Subjective Stuttering Scale (SSS) [ Time Frame: This scale is completed on Visit 2/baseline and Visit 5/week 8. ]
  3. 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. ]
  4. Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 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

  5. Barnes Akathisia Scale (BAS) [ Time Frame: This scale is completed on Visit 1/screening, Visit 5/week 8. ]
    measures how restless the subject is during the examination

  6. Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: This scale is completed on Visit 1/screening, Visit 5/week 8. ]
  7. 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. ]
  8. Simpson Angus Scale (SAS) [ Time Frame: This scale is completed on Visit 1/screening, Visit 5/week 8. ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909088


Locations
United States, California
CITrials Recruiting
Riverside, California, United States, 92506
Contact: Debra M Hoffmeyer, MA    952-300-4924    Debra@citrials.com   
University of California Riverside School of Medicine Not yet recruiting
Riverside, California, United States, 92521
Contact: Gerald A Maguire, MD       Gerald.Maguire@medsch.ucr.edu   
Contact: David L Franklin, PsyD       David.Franklin@medsch.ucr.edu   
Principal Investigator: Gerald Maguire, M.D.         
Sponsors and Collaborators
Gerald Maguire, MD
University of California Riverisde School of Medicine

Publications of Results:
Responsible Party: Gerald Maguire, MD, Professor and Chair, Psychiatry and Neuroscience, Principal Investigator, CITrials
ClinicalTrials.gov Identifier: NCT02909088     History of Changes
Other Study ID Numbers: EcoUCR001
IND 128278 ( Registry Identifier: FDA )
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Gerald Maguire, MD, CITrials:
stuttering
childhood onset fluency disorder
ecopipam

Additional relevant MeSH terms:
Stuttering
Disease
Language Disorders
Speech Disorders
Communication Disorders
Childhood-Onset Fluency Disorder
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Ecopipam
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action