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Study · Randomized controlled trial · n = 313 · 2014

7 results

Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial.

Boxer AL, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Golbe LI, Williams DR, Corvol JC, Ludolph A and 18 more

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Burn D, Lorenzl S, Litvan I, Roberson ED, Höglinger GU, Koestler M, Jack CR Jr, Van Deerlin V, Randolph C, Lobach IV, Heuer HW, Gozes I, Parker L, Whitaker S, Hirman J, Stewart AJ, Gold M, Morimoto BH

The Lancet. Neurology27 May 2014Cited by 237 (Europe PMC)

PMID24873720 (opens in a new tab)PMCIDPMC4129545 (opens in a new tab)DOI10.1016/s1474-4422(14)70088-2 (opens in a new tab)PepBankPUB-24873720
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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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with PSP, davunetide and placebo did not differ in PSPRS change from baseline.

    In plain wordsIn patients with PSP, davunetide did not change PSPRS scores more than placebo.

    Peptide
    Davunetide
    Outcome
    No significant changePSPRS change
    Study

    n = 313

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    30 mg twice daily · intranasal · 52 weeksAs given in this study (human).

    Measurements

    PSPRS median change from baseline
    11.8 NA
    davunetide
    95% CI of PSPRS median change
    10.5 to 13 NA
    davunetide
    PSPRS median change from baseline
    11.8 NA
    placebo
    95% CI of PSPRS median change
    10.5 to 13 NA
    placebo
    P value
    0.41 NA
    between groups

    Source sentences

    Summary
    The davunetide and placebo groups did not differ in the change from baseline in PSPRS (median 11·8 [95% CI 10·5 to 13·0] vs 11·8 [10·5 to 13·0], respectively, p=0·41) or SEADL (-0·20 [-0·20 to -0·17] vs -0·20 [-0·22 to -0·17], respectively, p=0·92).
    5 context sentences
    Summary · context
    In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA.
    Summary · context
    Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP.
    Summary · context
    Primary endpoints were the change from baseline in PSP Rating Scale (PSPRS) and Schwab and England Activities of Daily Living (SEADL) scale at up to 52 weeks.
    Summary · context
    Analysis was by intention to treat.
    Summary · context
    313 participants were randomly assigned to davunetide (n=157) or to placebo (n=156), and 241 (77%) completed the study (118 and 156 in the davunetide and placebo groups, respectively).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In patients with PSP, davunetide and placebo did not differ in SEADL change from baseline.

    In plain wordsIn patients with PSP, davunetide did not change daily living scores more than placebo.

    Peptide
    Davunetide
    Outcome
    No significant changeSEADL change
    Study

    n = 313

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Exercise and physical function · Nervous system and cognition
    Studied dose
    30 mg twice daily · intranasal · 52 weeksAs given in this study (human).

    Measurements

    SEADL median change from baseline
    −0.2 NA
    davunetide
    95% CI of SEADL median change
    −0.2 to −0.17 NA
    davunetide
    SEADL median change from baseline
    −0.2 NA
    placebo
    95% CI of SEADL median change
    −0.22 to −0.17 NA
    placebo
    P value
    0.92 NA
    between groups

    Source sentences

    Summary
    The davunetide and placebo groups did not differ in the change from baseline in PSPRS (median 11·8 [95% CI 10·5 to 13·0] vs 11·8 [10·5 to 13·0], respectively, p=0·41) or SEADL (-0·20 [-0·20 to -0·17] vs -0·20 [-0·22 to -0·17], respectively, p=0·92).
    5 context sentences
    Summary · context
    In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA.
    Summary · context
    Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP.
    Summary · context
    Primary endpoints were the change from baseline in PSP Rating Scale (PSPRS) and Schwab and England Activities of Daily Living (SEADL) scale at up to 52 weeks.
    Summary · context
    Analysis was by intention to treat.
    Summary · context
    313 participants were randomly assigned to davunetide (n=157) or to placebo (n=156), and 241 (77%) completed the study (118 and 156 in the davunetide and placebo groups, respectively).
  3. 03HumanRandomized controlled trialSafety outcome

    In patients with PSP, davunetide and placebo each had 54 serious adverse events.

    In plain wordsIn patients with PSP, davunetide and placebo each had 54 serious adverse events.

    Peptide
    Davunetide
    Outcome
    Not applicableSerious adverse events
    Study

    n = 313

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    30 mg twice daily · intranasal · 52 weeksAs given in this study (human).

    Measurements

    Serious adverse events
    54 events
    davunetide
    Serious adverse events
    54 events
    placebo

    Source sentences

    Summary
    54 serious adverse events were reported in each of the treatment groups, including 11 deaths in the davunetide group and ten in the placebo group.
    3 context sentences
    Summary · context
    In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA.
    Summary · context
    Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP.
    Summary · context
    Analysis was by intention to treat.
  4. 04HumanRandomized controlled trialSafety outcome

    In patients with PSP, 11 deaths occurred with davunetide versus ten with placebo.

    In plain wordsIn patients with PSP, 11 died with davunetide versus ten with placebo.

    Peptide
    Davunetide
    Outcome
    Not applicableDeaths
    Study

    n = 313

    Comparator
    placebo
    Outcome group
    Mortality · Whole body
    Studied dose
    30 mg twice daily · intranasal · 52 weeksAs given in this study (human).

    Measurements

    Deaths
    11 deaths
    davunetide
    Deaths
    10 deaths
    placebo

    Source sentences

    Summary
    54 serious adverse events were reported in each of the treatment groups, including 11 deaths in the davunetide group and ten in the placebo group.
    3 context sentences
    Summary · context
    In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA.
    Summary · context
    Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP.
    Summary · context
    Analysis was by intention to treat.
  5. 05HumanRandomized controlled trialSafety outcome

    In patients with PSP, epistaxis occurred in 18 (12%) with davunetide versus 13 (8%) with placebo.

    In plain wordsIn patients with PSP, nosebleeds occurred more often with davunetide than placebo.

    Peptide
    Davunetide
    Outcome
    IncreaseEpistaxis
    Study

    n = 312

    Comparator
    placebo
    Outcome group
    Adverse events · Respiratory
    Studied dose
    30 mg twice daily · intranasal · 52 weeksAs given in this study (human).

    Measurements

    Epistaxis
    18 participants
    davunetide
    Epistaxis
    12%
    davunetide
    Epistaxis
    13 participants
    placebo
    Epistaxis
    8%
    placebo

    Source sentences

    Summary
    The frequency of nasal adverse events was greater in the davunetide group than in the placebo group (epistaxis 18 [12%] of 156 vs 13 [8%] of 156, rhinorrhoea 15 [10%] vs eight [5%], and nasal discomfort 15 [10%] vs one [<1%]).
    3 context sentences
    Summary · context
    In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA.
    Summary · context
    Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP.
    Summary · context
    Analysis was by intention to treat.
  6. 06HumanRandomized controlled trialSafety outcome

    In patients with PSP, rhinorrhoea occurred in 15 (10%) with davunetide versus eight (5%) with placebo.

    In plain wordsIn patients with PSP, a runny nose occurred more often with davunetide than placebo.

    Peptide
    Davunetide
    Outcome
    IncreaseRhinorrhoea
    Study

    n = 312

    Comparator
    placebo
    Outcome group
    Adverse events · Respiratory
    Studied dose
    30 mg twice daily · intranasal · 52 weeksAs given in this study (human).

    Measurements

    Rhinorrhoea
    15 participants
    davunetide
    Rhinorrhoea
    10%
    davunetide
    Rhinorrhoea
    8 participants
    placebo
    Rhinorrhoea
    5%
    placebo

    Source sentences

    Summary
    The frequency of nasal adverse events was greater in the davunetide group than in the placebo group (epistaxis 18 [12%] of 156 vs 13 [8%] of 156, rhinorrhoea 15 [10%] vs eight [5%], and nasal discomfort 15 [10%] vs one [<1%]).
    3 context sentences
    Summary · context
    In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA.
    Summary · context
    Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP.
    Summary · context
    Analysis was by intention to treat.
  7. 07HumanRandomized controlled trialSafety outcome

    In patients with PSP, nasal discomfort occurred in 15 (10%) with davunetide versus one (<1%) with placebo.

    In plain wordsIn patients with PSP, nasal discomfort occurred more often with davunetide than placebo.

    Peptide
    Davunetide
    Outcome
    IncreaseNasal discomfort
    Study

    n = 312

    Comparator
    placebo
    Outcome group
    Adverse events · Respiratory
    Studied dose
    30 mg twice daily · intranasal · 52 weeksAs given in this study (human).

    Measurements

    Nasal discomfort
    15 participants
    davunetide
    Nasal discomfort
    10%
    davunetide
    Nasal discomfort
    1 participants
    placebo
    Nasal discomfort
    < 1%
    placebo

    Source sentences

    Summary
    The frequency of nasal adverse events was greater in the davunetide group than in the placebo group (epistaxis 18 [12%] of 156 vs 13 [8%] of 156, rhinorrhoea 15 [10%] vs eight [5%], and nasal discomfort 15 [10%] vs one [<1%]).
    3 context sentences
    Summary · context
    In a double-blind, parallel group, phase 2/3 trial, participants were randomly assigned with permuted blocks in a 1:1 ratio to davunetide (30 mg twice daily, intranasally) or placebo for 52 weeks at 48 centres in Australia, Canada, France, Germany, the UK, and the USA.
    Summary · context
    Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP.
    Summary · context
    Analysis was by intention to treat.

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 2/3NCT01110720

Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy

Allon Therapeuticsn = 313Oct 2010 to Dec 2012

Progressive Supranuclear Palsy

Trial pageClinicalTrials.govUpdated 17 Jan 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.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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