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Sponsored by: |
Pharmacology Research Institute |
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Information provided by: | Pharmacology Research Institute |
ClinicalTrials.gov Identifier: | NCT00239915 |
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.
Condition | Intervention | Phase |
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Persistent Developmental Stuttering |
Drug: Pagoclone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy 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. |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Pharmacology Research Institute | |
Riverside, California, United States, 92506 |
Principal Investigator: | Jon F. Heiser, M.D. | Pharmacology Research Institute |
Study ID Numbers: | PRI#600 |
Study First Received: | October 13, 2005 |
Last Updated: | April 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00239915 |
Health Authority: | United States: Food and Drug Administration |
Signs and Symptoms Speech Disorders Neurologic Manifestations Language Disorders |
Stuttering Neurobehavioral Manifestations Communication Disorders |
Nervous System Diseases |