StutteringPhase 3NCT01684657
A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
A Phase 3 study testing Asenapine in people with Stuttering, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering. It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stuttering
- What is being tested?
- Asenapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2014
- Phase
- Phase 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 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. 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 18-70. 6)Subjects will be of only English speaking.
Who cannot join
- Subjects will be excluded from the study for any of the following reasons:
- 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.
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- Subjects who are pregnant or nursing an infant.
- No minors (under the age of 18) will not be enrolled in this study as the research with this compound in children and adolescents has not been fully performed.
- Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Irvine Medical Center
Orange, California, 92868
About this study
The purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.
It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.
- Conditions
- Stuttering
- Being tested
- Asenapine
- Keywords
- Stuttering
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsenapineDrug
Also called Saphris
This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This is the comparator. Placebo will be matched to color, taste, size, and smell. |
| Asenapine | Experimental | This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study. Receives: Drug: Asenapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stuttering Severity Instrument
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: 10 minutes
Secondary outcomes (2)
Clinical Global Impression
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: 2 minutes
Barnes Akathisia Scale
Measures how restless the subject is during the examination.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Why it stopped: Study transferring to another facility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Gerald Maguire, University of California, Irvine
- Investigators
- Gerald Maguire, M.D., Principal investigator, UCIMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684657
- Sponsor's protocol ID
- Asenapine Stuttering
- Status last verified
- May 2014
- First submitted
- 24 Jul 2012
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering
- ClinicalTrials.gov ID
- NCT01684657
- Acronym / sponsor ID
- Asenapine Stuttering
- Conditions
- Stuttering
- Keywords
- Stuttering
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study transferring to another facility
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 13 Sep 2012 (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 purpose of this research study is to find out the potential benefits and safety of asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.
It is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | –This is the comparator. Placebo will be matched to color, taste, size, and smell. |
| Asenapine | Experimental | Drug: AsenapineThis is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must satisfy DSM-IV criteria for 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. 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 18-70. 6)Subjects will be of only English speaking.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| AsenapineAlso: SaphrisThis is an atypical antipsychotic that blocks dopamine and increase the serotonin level. | Drug | Asenapine |
Primary outcome
Stuttering Severity Instrument
Time frame: 10 minutes
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.
2 secondary outcomes
Clinical Global Impression
Time frame: 2 minutes
Barnes Akathisia Scale
Time frame: 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
Gerald Maguire, M.D. principal investigator
UCIMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Asenapine in people with Stuttering, run by University of California, Irvine at 1 site 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 5 inclusion and 9 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: paused, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stuttering Severity Instrument (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2014.