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A Phase 2a Trial In...
A Phase 2a Trial Investigating the Safety and Tolerability of the Novel Cortical Enhancer IRL752 in Parkinson's Disease Dementia
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- Svenningsson, P. (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Clin Neurosci, Sect Neurol, Stockholm, Sweden
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- Odin, Per (author)
- Lund University,Lunds universitet,Restorative Parkinson Unit,Forskargrupper vid Lunds universitet,Lund University Research Groups,Lund Univ, Dept Clin Sci Lund, Div Neurol, Lund, Sweden
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- Dizdar Segrell, Nil (author)
- Linköpings universitet,Linköping University,Linköping Univ, Dept Clin & Expt Med, Linköping, Sweden,Avdelningen för neuro- och inflammationsvetenskap,Medicinska fakulteten,Region Östergötland, Neurologiska kliniken i Linköping
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- Johansson, A. (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Clin Neurosci, Sect Neurol, Stockholm, Sweden
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- Grigoriou, Sotirios (author)
- Lund University,Lunds universitet,Neurologi, Lund,Sektion IV,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Neurology, Lund,Section IV,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund Univ, Dept Clin Sci Lund, Div Neurol, Lund, Sweden
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- Tsitsi, P. (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Clin Neurosci, Sect Neurol, Stockholm, Sweden
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- Wictorin, Klas (author)
- Helsingborg Hospital,Helsingborg Hosp, Dept Neurol, Helsingborg, Sweden
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- Bergquist, Filip, 1970 (author)
- University of Gothenburg,Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för farmakologi,Institute of Neuroscience and Physiology, Department of Pharmacology,Univ Gothenburg, Sahlgrenska Acad, Dept Pharmacol, Gothenburg, Sweden
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- Nyholm, Dag (author)
- Uppsala University,Uppsala Univ, Sweden
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- Rinne, J. (author)
- Turku University Hospital,Clin Res Serv Turku Oy, Turku, Finland; Turku Univ Hosp, Div Clin Neurosci, Turku, Finland
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- Hansson, Fredrik, 1987- (author)
- Uppsala universitet,Nationalekonomiska institutionen,Clin Trial Consultants, Sweden
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- Sonesson, C. (author)
- Integrative Research Laboratories Sweden AB,Integrat Res Labs AB, Gothenburg, Sweden
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- Tedroff, J. (author)
- Karolinska Institutet,Karolinska Institute,Integrative Research Laboratories Sweden AB,Karolinska Inst, Dept Clin Neurosci, Sect Neurol, Stockholm, Sweden; Integrat Res Labs AB, Gothenburg, Sweden
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(creator_code:org_t)
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- 2020-03-21
- 2020
- English.
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In: Movement Disorders. - : Wiley. - 0885-3185 .- 1531-8257. ; 35:6, s. 1046-1054
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Abstract
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- Background IRL752 is a novel small-molecule compound that acts to regioselectively enhance norepinephrine, dopamine, and acetylcholine neurotransmission in the cerebral cortex. Objective The primary objective of the trial was to investigate the safety and tolerability of IRL752 in patients with Parkinson's disease and dementia. Methods Patients with Parkinson's disease and dementia were randomized to IRL752 or placebo treatment (3:1 ratio) for 28 days. The study drug was given as an adjunct treatment to the patients' regular stable antiparkinsonian medication. Dosing was individually titrated for 14 days after which the dose was kept stable for an additional 14 days. Results A total of 32 patients were randomized to treatment, and 29 patients completed the 4-week treatment. Adverse events were generally mild and transient and were mostly reported during the dose titration phase. There were 2 serious adverse events, and none of them were related to the experimental treatment. The average dose achieved in the stable dose phase was 600 mg daily, yielding a 2-hour postdose plasma concentration of about 4 mu M on day 28. Exploratory assessment of secondary outcomes indicated efficacy for symptoms and signs known to be poorly responsive to levodopa. Conclusions IRL752 appears to be safe and well tolerated for a 4-week treatment in patients with Parkinson's disease and dementia. (c) 2020 International Parkinson and Movement Disorder Society
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmakologi och toxikologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmacology and Toxicology (hsv//eng)
Keyword
- apathy
- axial symptom
- cognition
- fall
- movement disorder
- cognitive impairment
- postural instability
- multicenter
- deficits
- Neurosciences & Neurology
- apathy
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Svenningsson, P.
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Odin, Per
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Dizdar Segrell, ...
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Johansson, A.
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Grigoriou, Sotir ...
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Tsitsi, P.
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Wictorin, Klas
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Bergquist, Filip ...
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Nyholm, Dag
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Rinne, J.
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Hansson, Fredrik ...
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Sonesson, C.
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Tedroff, J.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Neurosciences
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Neurology
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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- Articles in the publication
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Movement Disorde ...
- By the university
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University of Gothenburg
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Lund University
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Uppsala University
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Karolinska Institutet
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Linköping University