Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

March 31, 2011

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions
Parkinson's Disease
Interventions
DRUG

Tozadenant (SYN115) 60 mg BID

"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.~Total daily doses include 60 mg BID."

DRUG

Placebo

White-coated, modified-oval placebo tablets.

DRUG

Levodopa (L-dopa)

One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.

DRUG

Tozadenant (SYN115) 120 mg BID

"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.~Total daily doses include 120 mg BID."

DRUG

Tozadenant (SYN115) 180 mg BID

"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.~Total daily doses include 180 mg BID."

DRUG

Tozadenant (SYN115) 240 mg BID

"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.~Total daily doses include 240 mg BID."

Trial Locations (61)

10001

New York

11725

Commack

18001

Allentown

19019

Philadelphia

21201

Baltimore

24001

Roanoke

27517

Durham

29401

Charleston

30301

Atlanta

30901

Augusta

32601

Gainesville

33101

Miami

33326

Weston

33427

Boca Raton

33601

Tampa

35005

Birmingham

40502

Lexington

41073

Cincinnati

43004

Columbus

43460

Toledo

44101

Cleveland

46077

Indianapolis

48302

West Bloomfield

50047

Des Moines

53201

Milwaukee

55111

Minneapolis

62629

Springfield

66012

Kansas City

74008

Tulsa

75001

Dallas

77001

Houston

80014

Denver

83701

Boise

90001

Los Angeles

92037

La Jolla

92318

Loma Linda

93030

Oxnard

94016

San Francisco

06040

Manchester

06501

New Haven

Unknown

Buenos Aires

Santa Fe

Edmonton

Halifax

Ottawa

Montreal

Québec

Santiago

Valdivia

Brasov

Bucharest

Constanța

Târgu Mureş

Timișoara

Dnipropetrovsk

Donetsk

Kiev

Lviv

Poltava

Vinnytsia

Zaporizhzhya

Sponsors
All Listed Sponsors
lead

Biotie Therapies Inc.

INDUSTRY