Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).
NCT ID: NCT02909088
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2016-09-30
2017-11-30
Brief Summary
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It is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the SSI-IV total score, the CGI, SSS and OASES.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Ecopipam 50mg
Ecopipam 100mg
Ecopipam 100mg
If there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14.
Ecopipam 50mg
Ecopipam 100mg
Interventions
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Ecopipam 50mg
Ecopipam 100mg
Eligibility Criteria
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Inclusion 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
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.
18 Years
60 Years
ALL
No
Sponsors
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University of California Riverisde School of Medicine
UNKNOWN
Gerald Maguire, MD
OTHER
Responsible Party
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Gerald Maguire, MD
Professor and Chair, Psychiatry and Neuroscience, Principal Investigator
Locations
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CITrials
Riverside, California, United States
University of California Riverside School of Medicine
Riverside, California, United States
Countries
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Facility Contacts
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Debra M Hoffmeyer, MA
Role: primary
Gerald A Maguire, MD
Role: primary
David L Franklin, PsyD
Role: backup
References
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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.
Other Identifiers
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IND 128278
Identifier Type: REGISTRY
Identifier Source: secondary_id
EcoUCR001
Identifier Type: -
Identifier Source: org_study_id