Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study.

Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T

Archives of neurology1 May 2008Cited by 27 (Europe PMC)

PMID18474731DOI10.1001/archneur.65.5.577PepBankPUB-18474731

Publisher page PubMedAsk about this study

Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In advanced Parkinson disease, tesofensine 0.5 mg reduced UPDRS II plus III scores by 4.7 points relative to placebo.
In plain wordsIn advanced Parkinson disease, tesofensine 0.5 mg improved daily activity and motor scores more than placebo.
Peptide
Tesofensine
Outcome
DecreaseUPDRS II plus III score
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
0.5 mg daily · oral · 14 weeksAs given in this study (human).
Measurements
Adjusted mean difference
−4.7 points
UPDRS II plus III versus placebo
P value
0.005
0.5 mg versus placebo
Source sentences
Summary
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, and -7.1% in off time (-68 minutes, P =.02) with tesofensine, 0.25 mg.
4 context sentences(design, population, supporting numbers)
Summary · context
A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial.
Summary · context
Patients with advanced PD and levodopa-related motor fluctuations were enrolled.
Summary · context
Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks.
Summary · context
Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries.
Report a problemFND-1847473101
02HumanRandomized controlled trialEfficacy outcome
In advanced Parkinson disease, tesofensine 0.25 mg reduced waking off time by 7.1 percentage points versus placebo.
In plain wordsIn advanced Parkinson disease, tesofensine 0.25 mg reduced off time more than placebo.
Peptide
Tesofensine
Outcome
DecreaseOff time
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
0.25 mg daily · oral · 14 weeksAs given in this study (human).
Measurements
Adjusted mean difference
−7.1 percentage points
Percentage of waking hours in off time versus placebo
Adjusted mean difference
−68 minutes
Off time versus placebo
P value
0.02
0.25 mg versus placebo
Source sentences
Summary
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, and -7.1% in off time (-68 minutes, P =.02) with tesofensine, 0.25 mg.
4 context sentences(design, population, supporting numbers)
Summary · context
A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial.
Summary · context
Patients with advanced PD and levodopa-related motor fluctuations were enrolled.
Summary · context
Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks.
Summary · context
Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries.
Report a problemFND-1847473102
03HumanRandomized controlled trialPharmacokinetics
In advanced Parkinson disease, tesofensine plasma concentration increased with dosage.
In plain wordsIn advanced Parkinson disease, higher tesofensine dosages produced higher blood concentrations.
Peptide
Tesofensine
Outcome
IncreasePlasma concentration versus dose
Study
n: not reported in source
Analysis
Secondary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oral · 14 weeksAs given in this study (human).
Source sentences
Summary
The plasma concentration increased with the dosage, but no clear dose-response relationship was observed.
4 context sentences(design, population, supporting numbers)
Summary · context
A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial.
Summary · context
Patients with advanced PD and levodopa-related motor fluctuations were enrolled.
Summary · context
Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks.
Summary · context
Secondary end points were safety, pharmacokinetics, responder analysis (> or =20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia.
Report a problemFND-1847473104
04HumanRandomized controlled trialSafety outcome
In advanced Parkinson disease, gastrointestinal adverse events occurred more often with tesofensine than placebo, especially at higher dosages.
In plain wordsIn advanced Parkinson disease, tesofensine caused more gastrointestinal adverse events than placebo, especially at higher dosages.
Peptide
Tesofensine
Outcome
IncreaseGastrointestinal adverse events
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated · oral · 14 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages.
4 context sentences(design, population, supporting numbers)
Summary · context
A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial.
Summary · context
Patients with advanced PD and levodopa-related motor fluctuations were enrolled.
Summary · context
Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks.
Summary · context
Secondary end points were safety, pharmacokinetics, responder analysis (> or =20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia.
Report a problemFND-1847473106
05HumanRandomized controlled trialSafety outcome
In advanced Parkinson disease, neuropsychiatric adverse events occurred more often with tesofensine than placebo, especially at higher dosages.
In plain wordsIn advanced Parkinson disease, tesofensine caused more neuropsychiatric adverse events than placebo, especially at higher dosages.
Peptide
Tesofensine
Outcome
IncreaseNeuropsychiatric adverse events
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Adverse events · Nervous system and cognition
Studied dose
Dose not stated · oral · 14 weeksAs given in this study (human).
Source sentences
Summary
Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages.
4 context sentences(design, population, supporting numbers)
Summary · context
A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial.
Summary · context
Patients with advanced PD and levodopa-related motor fluctuations were enrolled.
Summary · context
Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks.
Summary · context
Secondary end points were safety, pharmacokinetics, responder analysis (> or =20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia.
Report a problemFND-1847473107
06HumanRandomized controlled trialEfficacy outcome
In advanced Parkinson disease, other tesofensine dosages did not produce statistically significant effects versus placebo.
In plain wordsIn advanced Parkinson disease, other tesofensine dosages did not show significant effects versus placebo.
Peptide
Tesofensine
Outcome
No significant changeEffects at other dosages
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
Dose not stated · oral · 14 weeksAs given in this study (human).
Source sentences
Summary
Other dosages did not induce statistically significant effects.
3 context sentences(design, population, supporting numbers)
Summary · context
A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial.
Summary · context
Patients with advanced PD and levodopa-related motor fluctuations were enrolled.
Summary · context
Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks.
Report a problemFND-1847473103

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT00148512

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

Boehringer Ingelheimn = 254Mar 2003 to Feb 2005

Parkinson Disease

Trial page ClinicalTrials.govUpdated 29 Oct 2013

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
21 Oct 2026, 15:58 UTC
Study results updated
Version 1
21 Oct 2026, 12:50 UTC
First added · source update from Europe PMC

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