A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations

Summary

The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.

Timeline

Start

2003-03

Primary completion

2005-02

Completion

2005-02

Outcome

Met primary endpoint

paper The adjusted mean differences (relative to placebo) were -4.7 points in UPDRS subscale II plus subscale III total score (P =.005) with tesofensine, 0.5 mg, PMID 18474731 ↗

paper and -7.1% in off time (-68 minutes, P =.02) with tesofensine, 0.25 mg. PMID 18474731 ↗

Publications

• Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T; ADVANS Study Group. Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study. Arch Neurol. 2008 May;65(5):577-83. doi: 10.1001/archneur.65.5.577.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tesofensine	Small molecule	0.125 mg	Oral
Subject	Tesofensine	Small molecule	0.25 mg	Oral
Subject	Tesofensine	Small molecule	0.5 mg	Oral
Subject	Tesofensine	Small molecule	1 mg	Oral

Indications