The RAPID study is a multicenter, randomized, double-blind, double dummy, parallel group study comparing TV-1203/carbidopa (TV-1203/CD) dispersible tablets with levodopa/carbidopa (LD/CD) tablets in advanced parkinson’s disease (PD) patients with motor fluctuations.
There will be a period of 2-6 weeks following the screening visit where potential subjects will start an open-label run-in period by replacing their daily immediate release LD/CD or LD/BZD doses with the formulation of LD/CD (4:1) tablets that will be used in the following double-blind treatment phase. Eligible subjects who have maintained an optimal and stable dose of the LD/CD in the run-in period for at least 2 weeks and adequately completed a total of 6 days of diaries, i.e., 3 days each of the “24 Hour” and “Time to ON” diaries ( at the end of the run-in period), will be randomized in a 1:1 ratio to one of the following groups:
1) TV-1203/CD dispersible tablets + placebo for LD/CD tablets
2) LD/CD tablets + placebo for TV-1203/CD dispersible tablets
The duration of the treatment (double-blind) phase will be 18 weeks, when dose adjustment is allowed during the first 8 weeks. All daily immediate release LD/CD doses (4:1 ratio) will be replaced by the equivalent doses of study drugs.
Our thanks to Teva Pharmaceutical Industries Ltd., Netanya, ISRAEL, who has graciously agreed to share the de-identified placebo data from the RAPID study. Therefore, the active treatment extension data will not be included along with any data that is specific to the study drug.
Below find the following documents:
1. RAPID Protocol Synopsis
2. RAPID Schedule of Activites (SOA)
3. RAPID Annotated CRFs (excluding BECK & MMSE due to copyright restrictions)
4. RAPID Data Dictionaries
5. Instructions for downloading data
6. Links to publications