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

PHASE3CompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

June 30, 2017

Study Completion Date

June 30, 2017

Conditions
Sialorrhea
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

Trial Locations (35)

21075

Elkridge

29615

Greenville

30329

Atlanta

32806

Orlando

33010

Rivne

33462

Atlantis

33486

Boca Raton

33980

Port Charlotte

38018

Cordova

45459

Centerville

48334

Farmington Hills

49027

Dnipropetrovsk

61068

Kharkiv

63110

St Louis

65025

Odesa

66160

Kansas City

66211

Overland Park

69600

Zaporizhzhya

74136

Tulsa

76008

Ivano-Frankivsk

78229

San Antonio

79010

Lviv

80045

Aurora

85013

Phoenix

85258

Scottsdale

85259

Scottsdale

88018

Uzhhorod

89145

Las Vegas

90033

Los Angeles

92354

Loma Linda

98034

Kirkland

98409

Tacoma

99202

Spokane

230017

Grodno

08818

Edison

All Listed Sponsors
lead

Supernus Pharmaceuticals, Inc.

INDUSTRY

NCT02610868 - Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults | Biotech Hunter | Biotech Hunter