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COMPLETED
NCT02610868
PHASE3

Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults

Sponsor: Solstice Neurosciences, LLC, a subsidiary of US WorldMeds, LLC

View on ClinicalTrials.gov

Summary

Multicenter, open-label, outpatient study of the safety and effectiveness of repeated doses of MYOBLOC over a 1-year duration in adult subjects with troublesome sialorrhea.

Official title: A Phase 3, Long-Term, Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

187

Start Date

2015-10

Completion Date

2017-06

Last Updated

2026-04-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

MYOBLOC

After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13, 17, 26, 30, 39, 43, and 52, and telephone follow up will occur at Weeks 21, 34, and 47

Locations (35)

Phoenix, Arizona, United States

Scottsdale, Arizona, United States

Scottsdale, Arizona, United States

Loma Linda, California, United States

Los Angeles, California, United States

Aurora, Colorado, United States

Atlantis, Florida, United States

Boca Raton, Florida, United States

Orlando, Florida, United States

Port Charlotte, Florida, United States

Atlanta, Georgia, United States

Kansas City, Kansas, United States

Overland Park, Kansas, United States

Elkridge, Maryland, United States

Farmington Hills, Michigan, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

Edison, New Jersey, United States

Centerville, Ohio, United States

Tulsa, Oklahoma, United States

Greenville, South Carolina, United States

Cordova, Tennessee, United States

San Antonio, Texas, United States

Kirkland, Washington, United States

Spokane, Washington, United States

Tacoma, Washington, United States

Grodno, Belarus

Dnipropetrovsk, Ukraine

Ivano-Frankivsk, Ukraine

Kharkiv, Ukraine

Lviv, Ukraine

Odesa, Ukraine

Rivne, Ukraine

Uzhhorod, Ukraine

Zaporizhzhya, Ukraine