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Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial
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Background In preclinical studies, davunetide promoted microtubule stability and reduced tau phosphorylation. Because progressive supranuclear palsy (PSP) is linked to tau pathology, davunetide could be a treatment for PSP. We assessed the safety and efficacy of davunetide in patients with PSP.Methods 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. Participants met the modified Neuroprotection and Natural History in Parkinson Plus Syndrome study criteria for PSP. 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. All participants and study personnel were masked to treatment assignment. Analysis was by intention to treat. The trial is registered with Clinicaltrials.gov, number NCT01110720.Findings 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). There were no differences in the davunetide and placebo groups in the baseline PSPRS and SEADL. 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). 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. 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%]).Interpretation Davunetide is not an effective treatment for PSP. Clinical trials of disease-modifying treatment are feasible in patients with PSP and should be pursued with other promising tau-directed treatments.Funding Allon Therapeutics.
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“In the latest phase II/III study162, patients with PSP were treated with NAP for 52 weeks, but no differences were found between placebo-treated and NAP-treated patients163.”
From Tau-targeting therapies for Alzheimer disease (2018) · cites this paper as [163]
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Metadata
- Authors
- Boxer, A. L., Lang, A. E., Grossman, M., Knopman, D. S., Miller, B. L., Schneider, L. S., Doody, R. S., Lees, A., Golbe, L. I., Williams, D. R., Corvol, J.-C., Ludolph, A., Burn, D., Lorenzl, S., Litvan, I., Roberson, E. D., Höglinger, G. U., Koestler, M., Jack, C. R., Van Deerlin, V., Randolph, C., Lobach, I. V., Heuer, H. W., Gozes, I., Parker, L., Whitaker, S., Hirman, J., Stewart, A. J., Gold, M., & Morimoto, B. H.
- Affiliations
- University of California, San Francisco (US)
- University of Toronto (CA)
- University of Pennsylvania (US)
- Mayo Clinic (US)
- University of Southern California (US)
- Baylor College of Medicine (US)
- UCL Queen Square Institute of Neurology (GB)
- Rutgers, The State University of New Jersey (US)
- Monash University (AU)
- University Hospital Ulm (DE)
- Newcastle University (GB)
- LMU Klinikum (DE)
- University of California San Diego (US)
- University of Alabama at Birmingham (US)
- Technical University of Munich (DE)
- Loyola University Chicago (US)
- Tel Aviv University (IL)
- Arbutus Biopharma (Canada) (CA)
- Omeros Corporation (United States) (US)
- Paladin Labs (Canada) (CA)
- Celerion (United States) (US)
- Corresponding author
- Boxer, Adam L
- ORCID
- Boxer, Adam L
- Lang, Anthony E
- Grossman, Murray
- Knopman, David S
- Miller, Bruce L
- Schneider, Lon S
- Lees, Andrew
- Golbe, Lawrence I
- Williams, David R
- Burn, David
- Lorenzl, Stefan
- Litvan, Irene
- Roberson, Erik D
- Höglinger, Günter U
- Jack, Clifford R
- Randolph, Christopher
- Lobach, Iryna V
- Heuer, Hilary W
- Gozes, Illana
- Stewart, Alistair J
- Venue
- The Lancet Neurology
- Publisher
- Elsevier BV
- Published
- 2014-07
- Volume
- 13
- Issue
- 7
- Pages
- 676-685
- ISSN
- 1474-4422 (ISSN-L)
- PMC
- PMC4129545
- OpenAlex
- W2129669150
- Cited by
- 294
- References
- 43
- Citations by year
- 2026: 21 · 2025: 18 · 2024: 15 · 2023: 22 · 2022: 16 · 2021: 25 · 2020: 27 · 2019: 33 · 2018: 23 · 2017: 27 · 2016: 36 · 2015: 20 · 2014: 10
- FWCI
- 20.20
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet Neurology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- Allos Therapeutics
- Topics
- Health Sciences › Medicine › Clinical Neurology › Parkinson's Disease Mechanisms and Treatments
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Clinical Neurology › Deep Brain Stimulation and Movement Disorders
- Keywords
- davunetide, progressive supranuclear palsy, tau pathology, microtubule stabilization, tau phosphorylation, intranasal drug delivery, neuroprotection, PSP Rating Scale, activities of daily living, drug safety, epistaxis, serious adverse events, atypical parkinsonism, disease-modifying therapy
- MeSH terms
- Aged, Double-Blind Method, Female, Humans, Male, Oligopeptides, Supranuclear Palsy, Progressive, Treatment Outcome
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