Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01766258
Brief Summary:
The primary objective of the study is to assess the efficacy, carbidopa dose response and safety of ODM-101, a new combination of levodopa, carbidopa and entacapone in the treatment of Parkinson's disease (PD) patients with end-of-dose motor fluctuations.
Detailed Description:
This is a randomised, double-blind, double-dummy, active-controlled, crossover, multicentre, phase II proof of concept study in patients with PD and end-of-dose motor fluctuations. The patient's individually optimised daily levodopa regimen must be kept stable for at least 2 weeks before randomisation. The patients will be randomised to receive ODM-101 with 65 mg of carbidopa, ODM-101 with 105 mg of carbidopa and Stalevo® according to a 3-period crossover design.
The study consists of a screening period, 3 treatment periods and a post-treatment period. For each patient,there will be 9 visits: a screening visit performed 7-28 days before randomisation, a randomisation visit (visit 1), 6 visits during the 3 treatment periods (i.e. 2, 4, 6, 8, 10 and 12 weeks after randomisation and the start of the study treatment; visits 2-7), and an end-of-study visit 7-21 days after the last visit of the last treatment period. The duration of study will be 14-23 weeks for each patient.
The patients switch to study drugs after all assessments have been done at visit 1. The strength of the levodopa in the study drug is determined by the patient's individually optimised levodopa regimen before randomisation. During the first 2 weeks of each treatment period, the patient's levodopa strength (but not frequency) in the study drug will be adjusted as necessary by the investigator. For the remaining 2 weeks of each treatment period, the levodopa strengths should be kept stable.
Unscheduled visits maybe performed during the first 2 weeks of each treatment period, if there is a need to adjust the levodopa strength. In case the patient has not contacted the study centre within a week after the start of the treatment period, the study personnel will phone the patient to ensure that the symptoms and possible adverse events (AEs) are sufficiently controlled and captured, and to assess the need to adjust the levodopa treatment.
Study:
NCT01766258
Study Brief:
Protocol Section:
NCT01766258