Efficacy and safety of leuprorelin in patients with spinal and bulbar muscular atrophy (JASMITT study): a multicentre, randomised, double-blind, placebo-controlled trial.

Katsuno M, Banno H, Suzuki K, Takeuchi Y, Kawashima M, Yabe I, Sasaki H, Aoki M, Morita M, Nakano I, Kanai K, Ito S and 17 more

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Ishikawa K, Mizusawa H, Yamamoto T, Tsuji S, Hasegawa K, Shimohata T, Nishizawa M, Miyajima H, Kanda F, Watanabe Y, Nakashima K, Tsujino A, Yamashita T, Uchino M, Fujimoto Y, Tanaka F, Sobue G

The Lancet. Neurology4 Aug 2010Cited by 137 (Europe PMC)

PMID20691641DOI10.1016/s1474-4422(10)70182-4PepBankPUB-20691641

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Summary

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

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In spinal and bulbar muscular atrophy, leuprorelin did not significantly reduce initial-swallow barium residue versus placebo.
In plain wordsIn spinal and bulbar muscular atrophy, leuprorelin did not significantly reduce initial-swallow residue versus placebo.
Peptide
Leuprolide
Outcome
No significant changeBarium residue after initial swallowing
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
11.25 mg every 12 weeks · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Change
−5.1%
leuprorelin
Difference
−5.3%
versus placebo
95% CI
−10.8 to 0.3%
difference
P
0.063
difference
Change
0.2%
placebo
Source sentences
Summary
At week 48, the pharyngeal barium residue after initial swallowing had changed by -5.1% (SD 21.0) in the leuprorelin group and by 0.2% (18.2) in the placebo group (difference between groups -5.3%; 95% CI -10.8 to 0.3; p=0.063).
2 context sentences(design, population, supporting numbers)
Summary · context
The Japan SBMA Interventional Trial for TAP-144-SR (JASMITT) was a 48-week, randomised, double-blind, placebo-controlled trial done at 14 hospitals between August, 2006, and March, 2008.
Summary · context
Patients with spinal and bulbar muscular atrophy were randomly assigned (1:1) by minimisation to subcutaneous 11.25 mg leuprorelin or identical placebo every 12 weeks.
Report a problemFND-2069164101
02HumanRandomized controlled trialSafety outcome
In spinal and bulbar muscular atrophy, drug-related adverse events did not differ significantly between leuprorelin and placebo.
In plain wordsIn spinal and bulbar muscular atrophy, drug-related adverse events did not differ significantly between leuprorelin and placebo.
Peptide
Leuprolide
Outcome
No significant changeDrug-related adverse events
Study
n = 199
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
11.25 mg every 12 weeks · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Patients with events
57 patients
100 leuprorelin recipients
P
0.727
between groups
Patients with events
54 patients
99 placebo recipients
Source sentences
Summary
There were no significant differences in the number of drug-related adverse events between groups (57 of 100 in the leuprorelin group and 54 of 99 in the placebo group; p=0.727).
2 context sentences(design, population, supporting numbers)
Summary · context
The Japan SBMA Interventional Trial for TAP-144-SR (JASMITT) was a 48-week, randomised, double-blind, placebo-controlled trial done at 14 hospitals between August, 2006, and March, 2008.
Summary · context
Patients with spinal and bulbar muscular atrophy were randomly assigned (1:1) by minimisation to subcutaneous 11.25 mg leuprorelin or identical placebo every 12 weeks.
Report a problemFND-2069164105
03HumanRandomized controlled trialEfficacy outcome
In spinal and bulbar muscular atrophy, unadjusted piecemeal-swallow barium residue was lower with leuprorelin than placebo.
In plain wordsIn spinal and bulbar muscular atrophy, unadjusted piecemeal-swallow residue was lower with leuprorelin than placebo.
Peptide
Leuprolide
Outcome
DecreaseBarium residue after piecemeal deglutition, unadjusted
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
11.25 mg every 12 weeks · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Difference
−3.2%
unadjusted
Interval
−6.4 to 0%
difference
P
0.049
unadjusted
Source sentences
Summary
The mean difference in pharyngeal barium residue after piecemeal deglutition at week 48 was -3.2% (-6.4 to 0.0; p=0.049), but there was no significant difference between the groups after covariate adjustment for the baseline data (-4.1 to 1.6; p=0.392).
2 context sentences(design, population, supporting numbers)
Summary · context
The Japan SBMA Interventional Trial for TAP-144-SR (JASMITT) was a 48-week, randomised, double-blind, placebo-controlled trial done at 14 hospitals between August, 2006, and March, 2008.
Summary · context
Patients with spinal and bulbar muscular atrophy were randomly assigned (1:1) by minimisation to subcutaneous 11.25 mg leuprorelin or identical placebo every 12 weeks.
Report a problemFND-2069164102
04HumanRandomized controlled trialEfficacy outcome
In spinal and bulbar muscular atrophy, adjusted piecemeal-swallow residue did not differ significantly between leuprorelin and placebo.
In plain wordsIn spinal and bulbar muscular atrophy, adjusted piecemeal-swallow residue did not differ significantly between leuprorelin and placebo.
Peptide
Leuprolide
Outcome
No significant changeBarium residue after piecemeal deglutition, adjusted
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
11.25 mg every 12 weeks · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Interval
−4.1 to 1.6%
adjusted difference
P
0.392
adjusted
Source sentences
Summary
The mean difference in pharyngeal barium residue after piecemeal deglutition at week 48 was -3.2% (-6.4 to 0.0; p=0.049), but there was no significant difference between the groups after covariate adjustment for the baseline data (-4.1 to 1.6; p=0.392).
2 context sentences(design, population, supporting numbers)
Summary · context
The Japan SBMA Interventional Trial for TAP-144-SR (JASMITT) was a 48-week, randomised, double-blind, placebo-controlled trial done at 14 hospitals between August, 2006, and March, 2008.
Summary · context
Patients with spinal and bulbar muscular atrophy were randomly assigned (1:1) by minimisation to subcutaneous 11.25 mg leuprorelin or identical placebo every 12 weeks.
Report a problemFND-2069164103
05HumanRandomized controlled trialEfficacy outcome
In a predefined subgroup of patients with disease duration under 10 years, leuprorelin treatment was associated with a greater reduction in initial-swallow barium residue than placebo.
In plain wordsIn a predefined subgroup with disease duration under 10 years, leuprorelin was associated with a greater reduction in initial-swallow residue than placebo.
Peptide
Leuprolide
Outcome
DecreaseInitial-swallow residue with disease duration less than 10 years
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
11.25 mg every 12 weeks · subcutaneous · 48 weeksAs given in this study (human).
Measurements
Difference
−9.8
subgroup
Interval
−17.1 to −2.5
subgroup
P
0.009
subgroup
Source sentences
Summary
In a predefined subgroup analysis, leuprorelin treatment was associated with a greater reduction in barium residue after initial swallowing than was placebo in patients with a disease duration less than 10 years (difference between groups -9.8, -17.1 to -2.5; p=0.009).
2 context sentences(design, population, supporting numbers)
Summary · context
The Japan SBMA Interventional Trial for TAP-144-SR (JASMITT) was a 48-week, randomised, double-blind, placebo-controlled trial done at 14 hospitals between August, 2006, and March, 2008.
Summary · context
Patients with spinal and bulbar muscular atrophy were randomly assigned (1:1) by minimisation to subcutaneous 11.25 mg leuprorelin or identical placebo every 12 weeks.
Report a problemFND-2069164104

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
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

Subjects

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