The TEMPO Study is a multicenter, double-blind, placebo-controlled, parallel group, Phase III clinical trial for the efficacy, tolerability and safety of two doses of rasagiline mesylate in early Parkinson’s disease (PD) subjects not treated with levodopa. Subjects were randomized to one of two (1 mg or 2 mg/day) dosages of rasagiline or placebo with a 1-week titration phase, followed by a 25-week maintenance phase and a 6-month active treatment extension.

Our thanks to Teva Pharmaceutical Industries Ltd., Netanya, ISRAEL, who has graciously agreed to share the de-identified placebo data from the TEMPO 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. TEMPO Protocol Synopsis
2. TEMPO Schedule of Activites (SOA)
3. TEMPO Annotated CRFs (excluding BECK & MMSE due to copyright restrictions)
4. TEMPO Data Dictionaries
5. Instructions for downloading data
6. Links to publications

Andrew Siderowf and the Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease: The TEMPO Study. Arch Neurol 2002;59:1937-1943.

Andrew Siderowf, Michael McDermott, Karl Kieburtz, Karen Blindauer, Sandra Plumb, Ira Shoulson and the Parkinson Study Group.Test-retest reliability of the Unified Parkinson’s Disease Rating Scale in patients with early Parkinson’s disease: Results from a multicenter clinical trial. Mov Disord 2002:17(4):758-763.

 

Andrew Siderowf  and the Parkinson Study Group. A controlled, randomized, delayed-start

study of rasagiline in early Parkinson’s disease. Arch Neurol 2004;61:561-566.

 

Andrew Siderowf, Shirley Eberly, David Oakes, Ira Shoulson on behalf of the Parkinson Study Group. Authors’ response: Re-examination of the TEMPO study. Arch Neurol 2005;62(8):1320-1321.

Only registered users who have been approved to download the TEMPO database are permitted to view/access the database files below (you must Login to access the data).