Persistent Developmental StutteringPhase 2NCT00239915
Safety and Efficacy Study of the Investigational Drug Pagoclone, in the Treatment of Persistent Developmental Stuttering (PDS)
A Phase 2 study testing Pagoclone in people with Persistent Developmental Stuttering, run by Pharmacology Research Institute at 1 site in United States.
Trial summary
This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Developmental Stuttering
- What is being tested?
- Pagoclone
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2006
- Phase
- Phase 2
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- PDS defined as DSM-IV-TR criteria
- Symptoms starting before age 8
- Total overall score of 18-36 on the SSI-3
- English speaking, with an 8th grade education
- Able to understand and cooperate with study requirements with assistance
- Not pregnant or breastfeeding
- Able to provide consent
Who cannot join
- No diagnoses of other CNS/Mental health disorders in the last 6 months
- No use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening
- No use of non-medicinal stuttering treatments for 5 months prior to the study
- No use of illicit drugs or opiates of any kind
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmacology Research Institute
Riverside, California, 92506
About this study
Official title: An 8-week, Double-Blind, Randomized, Multicenter, Flexible-Dose, Placebo-Controlled Pilot Study of Pagoclone in Patients With Persistent Developmental Stuttering Followed by a 52-week Open-Label Extension.
This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United States Food and Drug Administration.
- Conditions
- Persistent Developmental Stuttering
- Being tested
- Pagoclone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PagocloneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startApr 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Developmental 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pharmacology Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Jon F. Heiser, M.D., Principal investigator, Pharmacology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239915
- Sponsor's protocol ID
- PRI#600
- Status last verified
- May 2012
- First submitted
- 13 Oct 2005
- Last updated
- 9 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week, Double-Blind, Randomized, Multicenter, Flexible-Dose, Placebo-Controlled Pilot Study of Pagoclone in Patients With Persistent Developmental Stuttering Followed by a 52-week Open-Label Extension.
- ClinicalTrials.gov ID
- NCT00239915
- Acronym / sponsor ID
- PRI#600
- Conditions
- Persistent Developmental Stuttering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Pharmacology Research InstituteUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2006
- First posted
- 17 Oct 2005 (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.
This is a research study of the investigational drug, Pagoclone, in the treatment of persistent developmental stuttering (PDS), which includes frequent repetitions or prolongations of sounds or syllables or words, or frequent hesitations or pauses that disrupt the flow of speech. Pagoclone is an investigational drug, so it is not approved by the United States Food and Drug Administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PDS defined as DSM-IV-TR criteria
- Symptoms starting before age 8
- Total overall score of 18-36 on the SSI-3
- English speaking, with an 8th grade education
- Able to understand and cooperate with study requirements with assistance
Key exclusion criteria (4 listed)
- No diagnoses of other CNS/Mental health disorders in the last 6 months
- No use of psychotropic medication or other medication for stuttering within 4 weeks prior to screening
- No use of non-medicinal stuttering treatments for 5 months prior to the study
- No use of illicit drugs or opiates of any kind
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 |
|---|---|---|
| Pagoclone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2012.
Related trials for Persistent Developmental Stuttering
Recruiting
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Stuttering, Developmental Stuttering
Active, not recruitingPhase 3
Explorative Study for Treating Persistent Developmental Stuttering With Ramipril
Persistent Developmental Stuttering
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.
Jon F. Heiser, M.D. principal investigator
Pharmacology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pagoclone in people with Persistent Developmental Stuttering, run by Pharmacology Research Institute 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 9 May 2012. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 9 May 2012.