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Sökning: WFRF:(Rinne J) > Umeå universitet > Sjögren Magnus > Intraputamenal Cere...

Intraputamenal Cerebral Dopamine Neurotrophic Factor in Parkinson's Disease: A Randomized, Double-Blind, Multicenter Phase 1 Trial

Huttunen, Henri J. (författare)
Herantis Pharma Plc, Espoo, Finland
Booms, Sigrid (författare)
Herantis Pharma Plc, Espoo, Finland
Sjögren, Magnus (författare)
Umeå universitet,Psykiatri,Herantis Pharma Plc, Espoo, Finland
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Kerstens, Vera (författare)
Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet and Stockholm Health Care Services, Stockholm, Sweden
Johansson, Jarkko (författare)
Umeå universitet,Umeå centrum för funktionell hjärnavbildning (UFBI),Institutionen för strålningsvetenskaper
Holmnäs, Rebecka (författare)
Herantis Pharma Plc, Espoo, Finland
Koskinen, Jani (författare)
Herantis Pharma Plc, Espoo, Finland
Kulesskaya, Natalia (författare)
Herantis Pharma Plc, Espoo, Finland
Fazio, Patrik (författare)
Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet and Stockholm Health Care Services, Stockholm, Sweden; Department of Neurology, Karolinska University Hospital, Stockholm, Sweden
Woolley, Max (författare)
Renishaw Neuro Solutions Ltd, Gloucestershire, United Kingdom
Brady, Alan (författare)
Renishaw Neuro Solutions Ltd, Gloucestershire, United Kingdom
Williams, Julia (författare)
Renishaw Neuro Solutions Ltd, Gloucestershire, United Kingdom
Johnson, David (författare)
Renishaw Neuro Solutions Ltd, Gloucestershire, United Kingdom
Dailami, Narges (författare)
Renishaw Neuro Solutions Ltd, Gloucestershire, United Kingdom; Department of Computer Science and Creative Technology, University of the West of England, Bristol, United Kingdom
Gray, William (författare)
Renishaw Neuro Solutions Ltd, Gloucestershire, United Kingdom; Functional Neurosurgery, Neuroscience and Mental Health Innovation Institute, Cardiff University, Cardiff, United Kingdom
Levo, Reeta (författare)
Department of Neurology, Helsinki University Hospital, Helsinki, Finland; Clinicum, University of Helsinki, Helsinki, Finland
Saarma, Mart (författare)
Institute of Biotechnology, HiLIFE, University of Helsinki, Helsinki, Finland
Halldin, Christer (författare)
Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet and Stockholm Health Care Services, Stockholm, Sweden
Marjamaa, Johan (författare)
Clinicum, University of Helsinki, Helsinki, Finland; Department of Neurosurgery, Helsinki University Hospital, Helsinki, Finland
Resendiz-Nieves, Julio (författare)
Clinicum, University of Helsinki, Helsinki, Finland; Department of Neurosurgery, Helsinki University Hospital, Helsinki, Finland
Grubor, Irena (författare)
Department of Neurosurgery, Skåne University Hospital, Lund, Sweden
Lind, Göran (författare)
Department of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Eerola-Rautio, Johanna (författare)
Department of Neurology, Helsinki University Hospital, Helsinki, Finland; Clinicum, University of Helsinki, Helsinki, Finland
Mertsalmi, Tuomas (författare)
Department of Neurology, Helsinki University Hospital, Helsinki, Finland; Clinicum, University of Helsinki, Helsinki, Finland
Andréasson, Mattias (författare)
Department of Neurology, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Paul, Gesine (författare)
Department of Neurology, Skåne University Hospital, Lund, Sweden
Rinne, Juha (författare)
Turku PET Centre, University of Turku and Turku University Hospital, Turku, Finland
Kivisaari, Riku (författare)
Clinicum, University of Helsinki, Helsinki, Finland; Department of Neurosurgery, Helsinki University Hospital, Helsinki, Finland
Bjartmarz, Hjalmar (författare)
Department of Neurosurgery, Skåne University Hospital, Lund, Sweden
Almqvist, Per (författare)
Department of Neurosurgery, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
Varrone, Andrea (författare)
Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet and Stockholm Health Care Services, Stockholm, Sweden
Scheperjans, Filip (författare)
Department of Neurology, Helsinki University Hospital, Helsinki, Finland; Clinicum, University of Helsinki, Helsinki, Finland
Widner, Håkan (författare)
Department of Neurology, Skåne University Hospital, Lund, Sweden
Svenningsson, Per (författare)
Department of Neurology, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
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 (creator_code:org_t)
John Wiley & Sons, 2023
2023
Engelska.
Ingår i: Movement Disorders. - : John Wiley & Sons. - 0885-3185 .- 1531-8257. ; 38:7, s. 1209-1222
Relaterad länk:
https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
http://kipublication...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
Stäng  
  • Background: Cerebral dopamine neurotrophic factor (CDNF) is an unconventional neurotrophic factor that protects dopamine neurons and improves motor function in animal models of Parkinson's disease (PD). Objective: The primary objectives of this study were to assess the safety and tolerability of both CDNF and the drug delivery system (DDS) in patients with PD of moderate severity. Methods: We assessed the safety and tolerability of monthly intraputamenal CDNF infusions in patients with PD using an investigational DDS, a bone-anchored transcutaneous port connected to four catheters. This phase 1 trial was divided into a placebo-controlled, double-blind, 6-month main study followed by an active-treatment 6-month extension. Eligible patients, aged 35 to 75 years, had moderate idiopathic PD for 5 to 15 years and Hoehn and Yahr score ≤ 3 (off state). Seventeen patients were randomized to placebo (n = 6), 0.4 mg CDNF (n = 6), or 1.2 mg CDNF (n = 5). The primary endpoints were safety and tolerability of CDNF and DDS and catheter implantation accuracy. Secondary endpoints were measures of PD symptoms, including Unified Parkinson's Disease Rating Scale, and DDS patency and port stability. Exploratory endpoints included motor symptom assessment (PKG, Global Kinetics Pty Ltd, Melbourne, Australia) and positron emission tomography using dopamine transporter radioligand [18F]FE-PE2I. Results: Drug-related adverse events were mild to moderate with no difference between placebo and treatment groups. No severe adverse events were associated with the drug, and device delivery accuracy met specification. The severe adverse events recorded were associated with the infusion procedure and did not reoccur after procedural modification. There were no significant changes between placebo and CDNF treatment groups in secondary endpoints between baseline and the end of the main and extension studies. Conclusions: Intraputamenally administered CDNF was safe and well tolerated, and possible signs of biological response to the drug were observed in individual patients. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Neurology (hsv//eng)

Nyckelord

clinical trial
convection-enhanced delivery
movement disorder
neurotrophic factor
synucleinopathy
transcutaneous port

Publikations- och innehållstyp

ref (ämneskategori)
art (ämneskategori)

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