What were the results of the TEMPO (Rasagiline in Early Monotherapy for Parkinson's Disease Outpatients) study?

Updated: Aug 29, 2019
  • Author: Robert A Hauser, MD, MBA; Chief Editor: Selim R Benbadis, MD  more...
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In the TEMPO study, patients were randomized to treatment with rasagiline 1 mg/day for 12 months; rasagiline 2 mg/day for 12 months; or placebo for 6 months, followed by rasagiline 2 mg/day for 6 months. [74] Rasagiline administered at a dosage of 1 or 2 mg/day for the first 6 months resulted in improved Unified Parkinson Disease Rating Scale (UPDRS) scores relative to placebo; there was also a higher proportion of patients with treatment responses in the active treatment groups than in the placebo group. [74] In addition, both of the rasagiline groups showed significant differences, compared with the placebo group, in the motor and activities of daily living (ADL) subscales of the UPDRS and in the Parkinson Disease Quality of Life (PDQUALIF) scale. [74]

Over the 12 months of the TEMPO study, patients who were initially treated with placebo had a greater progression in clinical symptomatology as assessed by UPDRS scores than did patients who were treated with rasagiline for the full 12 months. This finding suggested that there was an effect over and above a simple symptomatic effect and potentially consistent with a disease-modifying effect. [76] When the TEMPO investigators looked at the long-term (6.5-year follow-up period) outcome of early rasagiline therapy relative to late therapy in early Parkinson disease, patients in the early rasagiline treatment group—who received the drug from the beginning of the TEMPO study—had significantly less worsening of their total UPDRS scores than patients in the delayed-start group, even as investigators added other antiparkinson medications as needed. [75]

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