Noradrenaline for Progressive Supranuclear Palsy Syndromes (NORAPS)
Research type
Research Study
Full title
Noradrenaline for Progressive Supranuclear Palsy Syndromes (NORAPS). \nA Randomised, Double-Blind, Placebo-Controlled, Crossover Design, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Oral Atomoxetine for the Treatment of Cognitive and Behavioural Change in Participants with Progressive Supranuclear Palsy Syndromes\n
IRAS ID
272063
Contact name
James B. Rowe
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust, R&D Department
Eudract number
2019-004472-19
ISRCTN Number
ISRCTN99462035
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
People with Progressive Supranuclear Palsy (PSP) experience movement and mobility problems and coexisting profound apathy and impulsivity, which impact greatly on the patient and its carer’s quality of life. Research so far has mostly focused on finding treatments to ease mobility problems. This clinical trial has therefore been designed to help determine how safe and efficient the medicine atomoxetine is for the treatment of apathy and impulsivity in people with PSP.\nIn order to do find this out, 84 people with PSP (and their carer) will be recruited from 3 NHS hospitals in the UK and atomoxetine will be compared with a placebo (a medicine designed to look like a drug but without any active ingredients). \nParticipation in the trial will be as follows:\nStage1: consent, screening and baseline – Patients will start by giving formal consent that they are willing to participate, alongside one of their family member/carer. This will be followed up by some assessments to confirm that there are no reasons why the patient cannot continue on the trial. \nStage 2:The patients that can take part will then be assigned randomly (like the toss of a coin) to either receive atomoxetine or placebo during 8 weeks. Participants will be asked to attend a research visits at the beginning and another at the end of this period and to take the study medication in between these visits. A series of tests and questionnaires will be completed at each visits to help answer the research question.\nStage 3: 2 weeks where the patient won’t take any study medication\nStage 4: This will be the same as Stage 2 but participants will switch to either placebo or atomoxetine depending on what they received during Stage 2.\nStage 5: Participants will be called and sent questionnaires 4 weeks after finishing Stage 4.\n
REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0416
Date of REC Opinion
11 Jan 2021
REC opinion
Further Information Favourable Opinion