Stuttering, AdultPhase 2/3NCT02909088
Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).
A Phase 2/3 study testing Ecopipam 50mg and Ecopipam 100mg in people with Stuttering, Adult and Childhood-onset Fluency Disorder, run by Gerald Maguire, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stuttering, Adult, Childhood-onset Fluency Disorder, Speech Disorders
- What is being tested?
- Ecopipam 50mg and Ecopipam 100mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Nov 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
CITrials
Riverside, California, 92506
Debra M Hoffmeyer, MA, 952-300-4924, Debra@citrials.com
- Not yet recruiting
University of California Riverside School of Medicine
Riverside, California, 92521
Gerald A Maguire, MD, Gerald.Maguire@medsch.ucr.edu
David L Franklin, PsyD, David.Franklin@medsch.ucr.edu
About this study
Official title: 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.
- Conditions
- Stuttering, Adult, Childhood-onset Fluency Disorder, Speech Disorders, Language Disorders, Communication Disorder
- Being tested
- Ecopipam 50mg, Ecopipam 100mg
- Keywords
- stuttering, childhood onset fluency disorder, ecopipam
- Medical subject headings
- Stuttering, Childhood-Onset Fluency Disorder, Speech Disorders, Language Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecopipam 50mgDrug
Ecopipam 100mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ecopipam 50mg; Drug: Ecopipam 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This scale is completed on Visit 1/screening and Visit 5/week 8.
Secondary outcomes (8)
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.
Measured: This scale is completed on Visit 1/screening, Visit 2/baseline, Visit 3/week 2, and Visit 5/week 8.
Subjective Stuttering Scale (SSS)
Measured: This scale is completed on Visit 2/baseline and Visit 5/week 8.
Overall Assessment of the Speaker's Experience of Stuttering (OASES)
Measured: This scale is completed on Visit 2/baseline and Visit 5/week 8.
Montgomery Asberg Depression Rating Scale (MADRS)
An observer-rated depression scale
Measured: 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
Measured: This scale is completed on Visit 1/screening, Visit 5/week 8.
Abnormal Involuntary Movement Scale (AIMS)
Measured: This scale is completed on Visit 1/screening, Visit 5/week 8.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: 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)
Measured: This scale is completed on Visit 1/screening, Visit 5/week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stuttering, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gerald Maguire, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of California Riverisde School of Medicine
- Responsible party
- Sponsor-investigator, Gerald Maguire, MD, CITrials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909088
- Sponsor's protocol ID
- EcoUCR001
- Other IDs
- IND 128278
- Status last verified
- Oct 2016
- First submitted
- 25 Aug 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
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.
PubMed 15328899Maguire 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.
PubMed 15212606Maguire 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.
PubMed 20075648Maguire 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.
PubMed 12849360Gilbert 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.
PubMed 24434529Riley 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.
PubMed 15026214Maguire 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.
PubMed 10917410
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering).
- ClinicalTrials.gov ID
- NCT02909088
- Acronym / sponsor ID
- EcoUCR001
- Conditions
- Stuttering, Adult, Childhood-onset Fluency Disorder, Speech Disorders, Language Disorders, Communication Disorder
- Keywords
- stuttering, childhood onset fluency disorder, ecopipam
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Gerald Maguire, MDUniversity, hospital or other
- Collaborators
- University of California Riverisde School of Medicine
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ecopipam 50mg | Experimental | Drug: Ecopipam 50mg, Drug: Ecopipam 100mg50mg 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 | Drug: Ecopipam 50mg, Drug: Ecopipam 100mgIf there is no improvement, then the subjects' dose will be increased to 100mg at bedtime beginning on day 14. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecopipam 50mg | Drug | Ecopipam 100mg, Ecopipam 50mg |
| Ecopipam 100mg | Drug | Ecopipam 100mg, Ecopipam 50mg |
Primary outcome
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.
8 secondary outcomes
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.
Subjective Stuttering Scale (SSS)
Time frame: This scale is completed on Visit 2/baseline and Visit 5/week 8.
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.
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.
Barnes Akathisia Scale (BAS)
Time frame: This scale is completed on Visit 1/screening, Visit 5/week 8.
Abnormal Involuntary Movement Scale (AIMS)
Time frame: This scale is completed on Visit 1/screening, Visit 5/week 8.
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.
Simpson Angus Scale (SAS)
Time frame: This scale is completed on Visit 1/screening, Visit 5/week 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Results publication: PubMed 15328899Maguire 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.
- Results publication: PubMed 15212606Maguire 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.
- Results publication: PubMed 20075648Maguire 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.
- Results publication: PubMed 12849360Maguire 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.
- Results publication: PubMed 24434529Gilbert 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.
- Results publication: PubMed 15026214Riley 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.
- Results publication: PubMed 10917410Maguire 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of California Riverside School of Medicine
Riverside, United States
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ecopipam 50mg and Ecopipam 100mg in people with Stuttering, Adult and Childhood-onset Fluency Disorder, run by Gerald Maguire, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909088, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.