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| ID | Type | Description | Link |
|---|---|---|---|
| IND 128278 | Registry Identifier | FDA |
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| Name | Class |
|---|---|
| University of California Riverisde School of Medicine | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Ecopipam 100mg | Experimental | If there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecopipam 50mg | Drug |
| ||
| Ecopipam 100mg |
| 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. |
| 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. |
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Inclusion Criteria:
Subjects can be enrolled in the study only if they meet all of the following criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CITrials | Recruiting | Riverside | California | 92506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15328899 | Result | 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. | |
| 15212606 | 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. |
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| Drug |
|
| 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. |
| University of California Riverside School of Medicine | Not yet recruiting | Riverside | California | 92521 | United States |
|
| 20075648 | 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. |
| 12849360 | 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. |
| 24434529 | 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. |
| 15026214 | 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. |
| 10917410 | 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. |
| ID | Term |
|---|---|
| D013342 | Stuttering |
| D000067454 | Childhood-Onset Fluency Disorder |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C058081 | ecopipam |
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