Randomized trial of the triple monoamine reuptake inhibitor NS 2330 (tesofensine) in early Parkinson's disease.

Hauser RA, Salin L, Juhel N, Konyago VL

Movement disorders : official journal of the Movement Disorder Society1 Feb 2007Cited by 37 (Europe PMC)

PMID17149725DOI10.1002/mds.21258PepBankPUB-17149725

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

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

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In early Parkinson disease, tesofensine 0.25 mg did not significantly improve total UPDRS scores versus placebo at week 14.
In plain wordsIn early Parkinson disease, tesofensine 0.25 mg did not significantly improve scores versus placebo at week 14.
Peptide
Tesofensine
Outcome
No significant changeUPDRS score at week 14, 0.25 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
0.25 mg daily · 14 weeksAs given in this study (human).
Measurements
Adjusted mean difference
−0.7 points
Week 14
P value
0.64
0.25 mg
Source sentences
Summary
Adjusted mean difference in total Unified Parkinson's Disease Rating Scale (UPDRS) scores from baseline to week 14 was -0.7 (P = 0.64) in the 0.25-mg group, -1.3 (P = 0.41) in the 0.5-mg group, and -1.7 (P = 0.27) in the 1.0-mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972501
02HumanRandomized controlled trialEfficacy outcome
In early Parkinson disease, tesofensine 0.5 mg did not significantly improve total UPDRS scores versus placebo at week 14.
In plain wordsIn early Parkinson disease, tesofensine 0.5 mg did not significantly improve scores versus placebo at week 14.
Peptide
Tesofensine
Outcome
No significant changeUPDRS score at week 14, 0.5 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
0.5 mg daily · 14 weeksAs given in this study (human).
Measurements
Adjusted mean difference
−1.3 points
Week 14
P value
0.41
0.5 mg
Source sentences
Summary
Adjusted mean difference in total Unified Parkinson's Disease Rating Scale (UPDRS) scores from baseline to week 14 was -0.7 (P = 0.64) in the 0.25-mg group, -1.3 (P = 0.41) in the 0.5-mg group, and -1.7 (P = 0.27) in the 1.0-mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972502
03HumanRandomized controlled trialEfficacy outcome
In early Parkinson disease, tesofensine 1.0 mg did not significantly improve total UPDRS scores versus placebo at week 14.
In plain wordsIn early Parkinson disease, tesofensine 1.0 mg did not significantly improve scores versus placebo at week 14.
Peptide
Tesofensine
Outcome
No significant changeUPDRS score at week 14, 1.0 mg
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
1.0 mg daily · 14 weeksAs given in this study (human).
Measurements
Adjusted mean difference
−1.7 points
Week 14
P value
0.27
1.0 mg
Source sentences
Summary
Adjusted mean difference in total Unified Parkinson's Disease Rating Scale (UPDRS) scores from baseline to week 14 was -0.7 (P = 0.64) in the 0.25-mg group, -1.3 (P = 0.41) in the 0.5-mg group, and -1.7 (P = 0.27) in the 1.0-mg group.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972503
04HumanRandomized controlled trialEfficacy outcome
In early Parkinson disease, tesofensine 1.0 mg/day improved total UPDRS scores versus placebo at week 6, but the effect was not sustained.
In plain wordsIn early Parkinson disease, tesofensine improved scores versus placebo at week 6, but the benefit did not persist.
Peptide
Tesofensine
Outcome
DecreaseUPDRS score at week 6
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
1.0 mg/day · 6 weeksAs given in this study (human).
Measurements
Adjusted mean difference
−3.1 points
Week 6 versus placebo
P value
0.02
Week 6
Source sentences
Summary
The adjusted mean difference in total UPDRS score for the highest dose group (1.0 mg/day) was superior to placebo at week 6 (-3.1; P = 0.02), but this effect was not sustained.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972504
05HumanRandomized controlled trialSafety outcome
In early Parkinson disease, tesofensine was generally well tolerated.
In plain wordsIn early Parkinson disease, participants generally tolerated tesofensine well.
Peptide
Tesofensine
Outcome
Not applicableGeneral tolerability
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
NS 2330 was generally well tolerated and the most commonly reported adverse events were constipation, insomnia, and dry mouth.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972505
06HumanRandomized controlled trialSafety outcome
In early Parkinson disease, constipation was among the most commonly reported tesofensine adverse events.
In plain wordsIn early Parkinson disease, constipation was a commonly reported adverse event with tesofensine.
Peptide
Tesofensine
Outcome
Direction not reportedConstipation
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
NS 2330 was generally well tolerated and the most commonly reported adverse events were constipation, insomnia, and dry mouth.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972506
07HumanRandomized controlled trialSafety outcome
In early Parkinson disease, insomnia was among the most commonly reported tesofensine adverse events.
In plain wordsIn early Parkinson disease, insomnia was a commonly reported adverse event with tesofensine.
Peptide
Tesofensine
Outcome
Direction not reportedInsomnia
Study
n: not reported in source
Outcome group
Sleep · Sleep
Studied dose
Dose not stated
Source sentences
Summary
NS 2330 was generally well tolerated and the most commonly reported adverse events were constipation, insomnia, and dry mouth.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972507
08HumanRandomized controlled trialSafety outcome
In early Parkinson disease, dry mouth was among the most commonly reported tesofensine adverse events.
In plain wordsIn early Parkinson disease, dry mouth was a commonly reported adverse event with tesofensine.
Peptide
Tesofensine
Outcome
Direction not reportedDry mouth
Study
n: not reported in source
Outcome group
Adverse events · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
NS 2330 was generally well tolerated and the most commonly reported adverse events were constipation, insomnia, and dry mouth.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972508
09HumanRandomized controlled trialSafety outcome
In early Parkinson disease, decreased body weight was common with tesofensine 1.0 mg.
In plain wordsIn early Parkinson disease, decreased body weight was common with tesofensine 1.0 mg.
Peptide
Tesofensine
Outcome
DecreaseDecreased body weight
Study
n: not reported in source
Outcome group
Body weight · Metabolic and weight
Studied dose
1.0 mg dailyAs given in this study (human).
Source sentences
Summary
Decreased body weight and elevated heart rate were common in the 1.0-mg dosage group.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972509
10HumanRandomized controlled trialSafety outcome
In early Parkinson disease, elevated heart rate was common with tesofensine 1.0 mg.
In plain wordsIn early Parkinson disease, elevated heart rate was common with tesofensine 1.0 mg.
Peptide
Tesofensine
Outcome
IncreaseElevated heart rate
Study
n: not reported in source
Outcome group
Adverse events · Cardiovascular
Studied dose
1.0 mg dailyAs given in this study (human).
Source sentences
Summary
Decreased body weight and elevated heart rate were common in the 1.0-mg dosage group.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a proof-of-concept, randomized, double-blind trial of NS 2330.
Summary · context
Two hundred sixty-one subjects with PD < 5 years and not receiving dopaminergic treatment were randomly assigned to daily treatment with NS 2330 at 0.25 mg, 0.5 mg, 1.0 mg, or placebo.
Report a problemFND-1714972510

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

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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