A Study of LY03003 in Patients With Early-stage Parkinson's Disease

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 22, 2013

Primary Completion Date

February 26, 2014

Study Completion Date

June 11, 2015

Conditions
Parkinson Disease
Interventions
DRUG

Rotigotine, extended-release microspheres

"Four stable dose levels of LY03003 at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:~* Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.~* Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.~* Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.~* Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks."

DRUG

Placebo, extended-release microspheres

"Four stable dose levels of placebo at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:~* Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.~* Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.~* Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.~* Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks."

All Listed Sponsors
collaborator

Beijing Bozhiyin T&S Co., Ltd.

INDUSTRY

lead

Luye Pharma Group Ltd.

INDUSTRY

NCT04044547 - A Study of LY03003 in Patients With Early-stage Parkinson's Disease | Biotech Hunter | Biotech Hunter