Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy (STRIDE-PD)

Novartis

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Drug: Immediate release carbidopa/levodopa; Drug: Carbidopa/levodopa/entacapone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00099268

CELC200A2401

Details and patient eligibility

About

The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

Enrollment: 747 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of idiopathic Parkinson's disease
• Diagnosis of Parkinson's disease for no more than 5 years

Exclusion criteria

• History, signs, or symptoms of atypical or secondary parkinsonism
• Presence at baseline of drug-related wearing-off symptoms, dyskinesia or other motor complications
• Levodopa exposure of more than 30 days or anytime within 8 weeks prior to visit 1

Other inclusion/exclusion criteria applied to this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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747 participants in 2 patient groups

Carbidopa/levodopa/entacapone

Experimental group

Description:

Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Treatment:

Drug: Carbidopa/levodopa/entacapone

Immediate release carbidopa/levodopa

Active Comparator group

Description:

Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.

Treatment:

Drug: Immediate release carbidopa/levodopa