Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy

What Was Tested

This registered phase 2, phase 3 trial tested Davunetide.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 313 actual participants took part.

It was open to people of any sex aged from 41 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Probable or possible PSP defined as:. At least a 12-month history of postural instability or falls during the first 3 years that symptoms are present; and. Age at symptom onset of 40 to 85 years by history; and. An akinetic-rigid syndrome with prominent axial rigidity. Aged 41 to 85 years at the time of screening.

The full record lists 17 inclusion and 34 exclusion criteria; among the exclusions: insufficient fluency in local language to complete neuropsychological and functional assessments; A diagnosis of Amyotrophic Lateral Sclerosis or other motor neuron disease; any of the following:.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Davunetide group and the comparison group should start out alike.

The Davunetide group and the comparison group ran side by side rather than switching.

As a double-blind Davunetide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-10 with completion listed for 2012-11.

It ran at 48 sites in United States (28), Germany (8), Canada (5), France (3), United Kingdom (3) and Australia (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Safety, as measured by reported AEs, electrocardiograms (ECG), nasal examinations and clinical laboratory measures (time frame: 52 weeks).

It also tracked 2 secondary outcomes, for example Brain atrophy, as measured by change from baseline of ventricular volumes measured by volumetric brain MRI at 52 weeks.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Davunetide in 313 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Davunetide compound page, all human trials.