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Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy

NCT01110720•Allon Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety and efficacy of davunetide for the treatment of Progressive Supranuclear Palsy.

Detailed Description

A Phase 2/3,Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy

Eligibility

Age

41 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•* at screening, a decreased downward saccade velocity defined as observable eye movement (deviation from the "main sequence" linear relationship between saccade amplitude and saccade velocity) or, supranuclear ophthalmoplegia defined as 50% reduction in upward gaze or 30% reduction in downward gaze; 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.
•Judged by investigator to be able to comply with neuropsychological evaluation at baseline and throughout the study.
•Must have reliable caregiver accompany subject to all study visits. Caregiver must read, understand, and speak local language fluently to ensure comprehension of informed consent form and informant-based assessments of subject. Caregiver must also have frequent contact with subject (at least 3 hours per week at one time or at different times) and be willing to monitor study medication compliance and the subject's health and concomitant medications throughout the study.
•Modified Hachinski score ≤ 3 (Appendix 7). This modified Hachinski will not include the focal neurological signs, symptoms or pseudobulbar affect questions, given the prominence of all 3 in PSP.
•Score ≥ 15 on the mini-mental state examination (MMSE) at screening (Visit 1).
+35 more criteria

Exclusion Criteria

•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:

Locations (48)

University of Alabama - Birmingham

Birmingham, Alabama, United States

Muhammed Ali Parkinson Center and Movement Disorders Clinic

Phoenix, Arizona, United States

Mayo Clinic, AZ

Scottsdale, Arizona, United States

USC Keck School of Medicine

Los Angeles, California, United States

David Geffen School of Medicine - UCLA

Los Angeles, California, United States

UCSD/VA Neurology Service

San Diego, California, United States

UCSF Memory and Aging Center

San Francisco, California, United States

Colorado Neurological Institute - Rocky Mountain Movement Disorders Ctr, PC

Englewood, Colorado, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Mayo Clinic, Florida

Jacksonville, Florida, United States

Key Dates

Start Date

October 1, 2010

Primary Completion Date

November 1, 2012

Completion Date

December 1, 2012

Last Updated

January 17, 2013

Enrollment

313

ACTUAL participants

Conditions

Progressive Supranuclear Palsy

Interventions

Davunetide

DRUG

Placebo

DRUG

UPenn Observational Research Repository on Neurodegenerative Disease

NCT04715399

Frontotemporal Degeneration(FTD)Primary Progressive Aphasia(PPA)+7 more

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RECRUITINGNA

The Swedish BioFINDER 2 Study

NCT03174938

DementiaAlzheimer Disease+10 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

UPenn Observational Research Repository on Neurodegenerative Disease

The Swedish BioFINDER 2 Study

The Use of the CUE1/CUE1+ in People With Parkinson's Disease and Related Disorders

Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy

Modifiable Variables in Parkinsonism (MVP)

Parkinson Atypical Rating of Oculometric Patterns Evaluated Routinely