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pagoclone

Phase 2

Stuttering | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 28, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment321

FDA Designations

No designations recorded

Clinical trial landscape

pagoclone · 1 trial · 1 indication

Phase 2 1
NCT00830154A Study to Assess the Efficacy and Safety of Pagoclone for Adults With StutteringStuttering
COMPLETED321 Analytics
PHASE2COMPLETED
A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering
StutteringUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
Weeks 8, 16 and 24

Secondary Endpoints

Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores.
24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL0.30 mg pagoclone BID
2EXPERIMENTAL0.60 mg pagoclone BID
3PLACEBO_COMPARATORplacebo

Interventions

NameTypeDescription
pagocloneDRUG0.30 mg BID, 0.60 mg BID
placeboOTHERplacebo
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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 ...

Countries:United States
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Frequently asked questions about pagoclone

What is pagoclone used for?

Pagoclone is an investigational small molecule being studied for the treatment of stuttering in adults. It is a Phase 2 investigational drug and is not approved by the FDA. Its development is being conducted by Teva Pharmaceutical Industries Limited.

Who makes pagoclone?

Pagoclone is being developed by Teva Pharmaceutical Industries Limited, which is listed on the stock exchange under the ticker TEVA. The company is conducting clinical research to evaluate the drug's safety and efficacy for stuttering.

What phase is pagoclone in?

Pagoclone is in Phase 2 clinical development. A Phase 2 study has been completed to assess its efficacy and safety in adults with stuttering. The drug remains investigational and has not received regulatory approval.

What clinical trials is pagoclone in?

Pagoclone has been studied in a completed Phase 2 clinical trial with the identifier NCT00830154. This trial was a randomized, double-blind, placebo-controlled study that enrolled 321 adults with stuttering in the United States.

Is pagoclone the same as any other drug?

Pagoclone is a distinct investigational drug and is not known to be the same as any other marketed medication. It is being evaluated specifically for stuttering and has no alternative names listed in its clinical development program.