Dasotraline SEP360-105 Pediatric PK/PD Study

PHASE1CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

March 31, 2015

Study Completion Date

March 31, 2015

Conditions
Pediatric Attention Deficit Hyperactivity Disorder
Interventions
DRUG

Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily

"Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg. The language should precede the text that is currently there"

Trial Locations (12)

27612

Wake Research, Raleigh

30030

iResearch Atlanta, LLC, Decatur

30308

Atlanta Center for Medical Research, Atlanta

33012

Palm Springs Research Institute, Hialeah

70114

Louisiana Research Associates, Inc, New Orleans

72211

Woodland International Research Group, Little Rock

73103

IPS Research Company, Oklahoma City

73116

Cutting Edge Research Group, Oklahoma City

78229

Clinical Trials of Texas, Inc. (CTT), San Antonio

78258

Road Runner Research, San Antonio

80910

MCB Clinical Research Centers, LLC, Colorado Springs

84058

Aspen Clinical Research, Orem

All Listed Sponsors
lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT02195167 - Dasotraline SEP360-105 Pediatric PK/PD Study | Biotech Hunter | Biotech Hunter