StutteringPhase 2/3NCT00830154
A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering
A Phase 2/3 study testing pagoclone in people with Stuttering, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in United States.
Trial summary
A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stuttering
- What is being tested?
- pagoclone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old.
- Stuttering severity must be notable for > 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks.
Who cannot join
- Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 3 Arm, Double-blind, Placebo-controlled Parallel Group Study to Assess the Efficacy,Safety and Tolerability of Pagoclone for Adults With Stuttering
A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.
Read the detailed description
A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase.
- Conditions
- Stuttering
- Being tested
- pagoclone, placebo
- Keywords
- stutter, stuttering, Adults with a history of stuttering
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pagocloneDrug
0.30 mg BID, 0.60 mg BID
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 0.30 mg pagoclone BID Receives: Drug: pagoclone |
| 2 | Experimental | 0.60 mg pagoclone BID Receives: Drug: pagoclone |
| 3 | Placebo comparator | placebo Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo.
Measured: Weeks 8, 16 and 24
Secondary outcomes (1)
Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2011
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830154
- Sponsor's protocol ID
- IP456-041
- Status last verified
- Aug 2012
- First submitted
- 25 Jan 2009
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Arm, Double-blind, Placebo-controlled Parallel Group Study to Assess the Efficacy,Safety and Tolerability of Pagoclone for Adults With Stuttering
- ClinicalTrials.gov ID
- NCT00830154
- Acronym / sponsor ID
- IP456-041
- Conditions
- Stuttering
- Keywords
- stutter, stuttering, Adults with a history of stuttering
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 27 Jan 2009 (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.
A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy, safety and tolerability of pagoclone for adults with stuttering.
Detailed description
A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of double blind treatment followed by an 8 week double blind washout and then long-term open-label extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: pagoclone0.30 mg pagoclone BID |
| 2 | Experimental | Drug: pagoclone0.60 mg pagoclone BID |
| 3 | Placebo comparator | Other: placeboplacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old.
- Stuttering severity must be notable for > 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually from conversational and reading tasks.
Key exclusion criteria (1 listed)
- Patients with unstable hematological, autoimmune, endocrine, neurological, renal, hepatic, retinal, gastrointestinal, or cardiovascular disease.
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 |
|---|---|---|
| pagoclone0.30 mg BID, 0.60 mg BID | Drug | 1, 2 |
| placeboplacebo | Other | 3 |
Primary outcome
To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo.
Time frame: Weeks 8, 16 and 24
1 secondary outcome
Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores.
Time frame: 24 weeks
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 28 Aug 2012.
- Click here for more information about this studyLink 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.
1 site 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 pagoclone in people with Stuttering, run by Endo USA Inc., a Keenova Therapeutics Company 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 2 inclusion and 1 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 28 Aug 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. 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 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?
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?
To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo. (time frame: Weeks 8, 16 and 24). 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 28 Aug 2012.