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Carbidopa/levodopa/entacapone · 1 trial · 1 indication
Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered "yes" to the following question: "In your opinion, does this patient have dyskinesia?" Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.
| Arm | Type | Description |
|---|---|---|
| Carbidopa/levodopa/entacapone | EXPERIMENTAL | 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. |
| Immediate release carbidopa/levodopa | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Carbidopa/levodopa/entacapone | DRUG | Carbidopa/Levodopa/Entacapone 12.5/50/200 mg and 25/100/200 mg capsules. |
| Immediate release carbidopa/levodopa | DRUG | Immediate release carbidopa/levodopa 12.5/50 mg and 25/100 mg capsules. |
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...
Carbidopa/levodopa/entacapone is used for Parkinson's Disease. It is a combination small molecule therapy being developed by Novartis AG. The drug is currently in Phase 3 clinical development and is intended for patients with Parkinson's Disease who require initiation of levodopa therapy.
Carbidopa/levodopa/entacapone combines three components: carbidopa, levodopa, and entacapone. Levodopa is a precursor to dopamine, which is deficient in Parkinson's Disease. Carbidopa prevents the breakdown of levodopa in the periphery, and entacapone inhibits the enzyme COMT, extending the effect of levodopa in the brain.
Carbidopa/levodopa/entacapone is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is publicly traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's efficacy and safety in Parkinson's Disease.
Carbidopa/levodopa/entacapone is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug is being evaluated for use in patients with Parkinson's Disease requiring initiation of levodopa therapy.
Carbidopa/levodopa/entacapone has one completed Phase 3 clinical trial with the identifier NCT00099268. This trial evaluated the efficacy and safety of the drug in 747 patients with Parkinson's Disease. The study was randomized, double-blind, and active-controlled, and it took place across multiple countries including the United States and several European nations.
Carbidopa/levodopa/entacapone is a combination of carbidopa, levodopa, and entacapone. This triple combination is marketed under the brand name Stalevo. The drug is being developed by Novartis AG for the treatment of Parkinson's Disease.