Persistent Developmental StutteringPhase 2NCT00216255
EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
A Phase 2 study testing Pagoclone in people with Persistent Developmental Stuttering, run by Endo USA Inc., a Keenova Therapeutics Company at 16 sites in United States.
Trial summary
The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 16 sitesUnited States
- Study dates
- Apr 2005to Jul 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PDS defined as DSM-IV-TR criteria, symptoms starting before age 8, and a total overall score of 18-36 on the SSI-3
- English-speaking, with 8th grade education, able to understand and cooperate with study requirements without assistance
- Not pregnant or breastfeeding
- Able to 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
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Atlanta Institute of Medicine & Research-Atlanta Clinic
Atlanta, Georgia, 30328
FutureSearch Trials
Austin, Texas, 78756
Social Psychiatry Research Institute
Brooklyn, New York, 11235
Midwest Clinical Research Center
Dayton, Ohio, 45408
Davis Clinic PC
Indianapolis, Indiana, 46202
Social Psychiatry Research Institute
New York, New York, 10021
University of California, Irvine Medical School
Orange, California, 92868
Vince and Associates Clinical Research
Overland Park, Kansas, 66211
Pivotal Research Centers
Peoria, Arizona, 85381
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Pharmacology Research Institute
Riverside, California, 92506
Pivotal Research Centers
Royal Oak, Michigan, 48073
University of Utah
Salt Lake City, Utah, 84132
University of Texas, Health Science Center
San Antonio, Texas, 78229
University of South Florida College of Medicine
Tampa, Florida, 33613-4788
Pacific Clinical Research Medical Group
Upland, California, 91786
About this study
Official title: An 8-week, Double-blind, Randomized, Multicenter, Flexible-dose, Placebo Controlled Pilot Study of Pagoclone in Patients With PDS Followed by a 52-week Open-label Extension
The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.
- Conditions
- Persistent Developmental Stuttering
- Being tested
- Pagoclone, Placebo
- Keywords
- Persistent Developmental Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PagocloneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pagoclone | Experimental | .15mg, .30mg, .60mg Receives: Drug: Pagoclone |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Pagaclone
Primary objective using a flexible dosing titration regimen from 0.15mg Pagocolne BID, titrated at 2 weeks to 0.30mg Pagaclone BID for an additional 6 weeks versus placebo, on persistent developmental stuttering in patients 18 to 65 years of age over an 8 week, double blind treatment period, followed by five 53 week open label treatment extension periods. The primary efficacy variables will be based on data collected on the stuttering Severity Instrument-3 (SSI-3) Frequency and Duration Subscore, the Subjective Screening of Stuttering (SSS) Severity Subscore, and the treatment and week 8 visits. All efficacy assessments will evaluate change from pre-treatment to each on-treatment week.
Measured: 8 weeks double blind followed by a 52 weeks open label
Secondary outcomes (1)
Secondary Objectives
SSI-3 Total overall Score and individual subscores (including frequency, duration, and physical concomitant subscores) Subjective Screening of Stuttering (SSS) test Speech Naturalness Scales (SNS) Liebowitz Social Anxiety Scale (LSAS) Stuttering Clinician's Global Impression-Improvement (CGI) Optional Neuropsychological Test Optional Functional Brain Imaging
Measured: Pre-treatment through week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJul 2011
- Study completionJul 2011
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216255
- Sponsor's protocol ID
- IP456-039
- Status last verified
- Aug 2012
- First submitted
- 16 Sep 2005
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 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 PDS Followed by a 52-week Open-label Extension
- ClinicalTrials.gov ID
- NCT00216255
- Acronym / sponsor ID
- IP456-039
- Conditions
- Persistent Developmental Stuttering
- Keywords
- Persistent Developmental Stuttering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 Sep 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.
The objective of the study is to determine the effects of pagoclone on the symptoms of Persistent Developmental Stuttering, using a flexible dosing titration regimen on persistent developmental stuttering in patients 18 to 65 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pagoclone | Experimental | Drug: Pagoclone.15mg, .30mg, .60mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PDS defined as DSM-IV-TR criteria, symptoms starting before age 8, and a total overall score of 18-36 on the SSI-3
- English-speaking, with 8th grade education, able to understand and cooperate with study requirements without assistance
- Not pregnant or breastfeeding
- Able to consent
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 | Pagoclone |
| Placebo | Drug | Placebo |
Primary outcome
Effects of Pagaclone
Time frame: 8 weeks double blind followed by a 52 weeks open label
Primary objective using a flexible dosing titration regimen from 0.15mg Pagocolne BID, titrated at 2 weeks to 0.30mg Pagaclone BID for an additional 6 weeks versus placebo, on persistent developmental stuttering in patients 18 to 65 years of age over an 8 week, double blind treatment period, followed by five 53 week open label treatment extension periods. The primary efficacy variables will be based on data collected on the stuttering Severity Instrument-3 (SSI-3) Frequency and Duration Subscore, the Subjective Screening of Stuttering (SSS) Severity Subscore, and the treatment and week 8 visits. All efficacy assessments will evaluate change from pre-treatment to each on-treatment week.
1 secondary outcome
Secondary Objectives
Time frame: Pre-treatment through week 8
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 3 Sep 2012.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites 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 Endo USA Inc., a Keenova Therapeutics Company at 16 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 4 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 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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 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.
What does the primary outcome measure?
Effects of Pagaclone (time frame: 8 weeks double blind followed by a 52 weeks open label). 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 3 Sep 2012.