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

What Was Tested

In this phase 2 trial, researchers set out to test Tesofensine (non-peptide) for parkinson's disease.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 254 actual participants took part.

It was open to people of any sex aged from 42 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female patient with idiopathic Parkinson Disease (PD) diagnosed for at least 2 years. Patient aged 40 years or over at time of diagnosis of PD and not older than 80 years at screening visit. Modified Hoehn and Yahr stage of II to III at "on" time. Motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: other medical exclusions, like ecg abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Tesofensine (non-peptide) and who got the comparison, which limits bias.

The Tesofensine (non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the parkinson's disease participants and researchers unaware of who received Tesofensine (non-peptide).

It started in 2003-03 with completion listed for 2005-02.

It ran at 50 sites in Germany (16), France (10), United Kingdom (7), Austria (6), Spain (6) and Netherlands (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): UPDRS parts II (averaged "on" and "off") (time frame: 14 weeks). "Off" time during waking hours (time frame: 14 weeks).

It also tracked 8 secondary outcomes, for example Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia, Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores, Auditory Verbal Learning test (AVLT), Modified Schwab and England Disability scale and Snaith-Hamilton Pleasure Scale (SHAPS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesofensine (non-peptide) in 254 people with parkinson's disease.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tesofensine (non-peptide) compound page, Parkinson's disease research.