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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
James
Rowe
+44 (0) 1223 273 630
james.rowe@mrc-cbu.cam.ac.uk
Dr
Estelle
Payerne
+44 (0) 1603 591263
e.payerne@uea.ac.uk
Progressive supranuclear palsy
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The illness Progressive Supranuclear Palsy (PSP) is best known for its effect on movement and balance, but it also causes apathy and impulsivity. These behavioural changes can have a big impact on the quality of life for patients and their carers. There is evidence that these behavioural changes are caused, in part, by a loss of the brain's natural adrenaline (called noradrenaline). This new clinical trial is designed to restore the levels of noradrenaline, using a drug called atomoxetine. This clinical trial aims to look at the safety and tolerability of atomoxetine in people with PSP.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
People with Progressive Supranuclear Palsy (PSP): 1. Use of monoamine oxidase inhibitor, SNRI, or other drugs that alter monoamine concentrations (including tricyclic antidepressants with the exception of low dose amitriptyline ≤ 30mg), systemic pressor agents, and any other medication that in the view of the PI would contraindicate participation within 2 weeks of visit 12. Use of high dose (>10 mg) systemic steroids (such as prednisolone). Topical steroid and low dose systemic steroid use are acceptable even if taken long term.3. Presence of significant cardiovascular disease such as ischaemic heart disease, cardiac rhythm abnormalities, or other clinically significant non-ischemic cardio-vascular disease. If at risk, including those with a family history of ischemic heart disease (parent with heart failure at 30 to 50 years) will undergo an electrocardiogram (ECG) at baseline to confirm eligibility.4. Narrow (acute) angle glaucoma5. History of, or current, pheocromocytoma6. Known hepatic or renal failure (ALT or AST over three times reference range and total birulin >2 times the reference range; eGFR <60 ml/min; and/or serum creatinine >168 mol/l). 7. Presence or history of a medical condition that the PI feels may interfere with the participant’s ability to comply with study instructions, would place the participant at increased risk, or might confound the interpretation of the study results8. History of cancer within 3 years of visit 1 with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer9. Presence of significant neurological (other than PSP) or psychiatric disorders including any psychotic disorder, clinically significant depression, suicidal thoughts or behaviour that are believed by the PI to represent a current safety risk (including a seizure within 3 years of visit 1 or history of recurrent seizures)10. Known presence of a disease-associated mutation in genes known as C9ORF72, GRN, CHMP2B, TBK1, TARBP, or VCP or other frontotemporal lobar degeneration (FTLD) causative genes which are not associated with underlying tau pathology (individuals with MAPT mutations may participate if they meet all other eligibility criteria)11. Any major surgery within 28 days of visit 112. Evidence of organ dysfunction or any clinically significant deviation from normal function in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population13. Recent (in the last month) or current systemic infections (recent vaccination is not an exclusion criteria)14. Current participation in any other clinical trial of an investigational medicinal product15. Likely inability to give blood (such as fear of needles, etc.) 16. Insufficient proficiency in English to provide informed consent and to understand task instructions, as assessed by the clinical or study team17. Body weight outside of the range 40 kg to 120 kg18. Contraindications for MRI (only applicable for those consenting to MRI)19. Breastfeeding20. Any other contraindication to atomoxetine treatment as detailed in atomoxetine SmPC including, but not limited to, hypersensitivity to the active substance or to any of the excipients
Research partner:1. Does not meet inclusion criteria
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Estelle
Payerne
+44 (0) 1603 591263
e.payerne@uea.ac.uk
Prof
James
Rowe
+44 (0) 1223 273 630
james.rowe@mrc-cbu.cam.ac.uk
The study is sponsored by Cambridge University Hospitals NHS Foundation Trust and funded by Medical Research Council; National Institute for Health Research (NIHR) (UK); Cambridge Centre for Parkinson-plus (CCPP).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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You can print or share the study information with your GP/healthcare provider or contact the research team directly.
