Scientific Title:

NORAPS - A Randomised, Double-Blind, Placebo-Controlled, Crossover Design Clinical Trial to Evaluate the Efficacy and Safety of Oral Atomoxetine for the Treatment of Behavioural and Cognitive Change in Progressive Supranuclear Palsy Syndromes.

Chief Investigator:

Professor James B. Rowe (Professor of Cognitive Neurology and Consultant Neurologist), Department of Clinical Neurosciences.

Funder:

Cambridge Centre for Parkinson-Plus

Sponsor:

Cambridge University Hospitals Trust and University of Cambridge

Health Condition or Problem Studied:

Participants with a confirmed diagnosis of possible or probable progressive supranuclear palsy, including the phenotypic variants of PSP-Richardson Syndrome (PSP-RS), PSP Frontal Variant (PSP-F), PSP with Corticobasal Syndrome (PSP-CBS), PSP with Speech and Language Deficits (PSP-SL), and PSP-RS following initial presentation of Progressive Gait Freezing (PSP-PGF); under the Movement Disorders Society (MDS) criteria (Höglinger et al., 2017).

Investigational medicinal product and dosage:

Atomoxetine 40mg (10 ml of 4mg/ml Oral solution), once daily

Active comparator product:

Resembling Placebo

Study Design:

This study is a Phase IIb, randomised, controlled, crossover design clinical trial

Target Sample Size:

84 participants and 84 suitable informants

Status:

Recruiting