Progressive Supranuclear Palsy Trial with Davunetide

Summary

Study director: Adam Boxer, MD, PhD
Sponsor: Allon Therapeutics, Inc.
Recruiting?: No
Official study title: 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
ClinicalTrials.gov identifier: NCT01110720
Conditions studied: Progressive supranuclear palsy
Intervention Drugs: Davunetide and placebo control
Phase: Phase II/III
Purpose: The purpose of the study is to evaluate the safety and efficacy of davunetide for the treatment of progressive supranuclear palsy (PSP).

Exclusionary medications: memantine, acetylcholinesterase inhibitors, antipsychotic agents (other than quetiapine), mood stabilizers (e.g., valproate, lithium) or benzodiazepines (other than temazepam or zolpidem) within four weeks of screening or during the trial
Parkinson’s medications, such as levodopa-carbidopa, must be stable for at least 90 days prior to screening
All other chronic medications must be stable for at least 30 days prior to screening
The patient must be able to ambulate independently or with assistance (assistance is taking at least five steps with a walker or with assistance of another person who can only have contact with one upper extremity)
Within five years of the screening visit, no history of cancer, other than non-metastatic basal cell carcinoma of the skin
Within the past 20 years, no history of stroke or head injury with loss of consciousness for at least 15 minutes
Able to tolerate an MRI without sedation
Mini Mental State Exam ≥ 15
Must have reliable caregiver accompany subject to all study visits to ensure comprehension of informed consent form and informant-based assessments of the subject. Caregiver must have frequent contact with the subject (at least three 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

The above is an amended list of inclusion and exclusion criteria. For an expanded list, please see clinicaltrials.gov

Testing: Neurological and physical examinations, cognitive testing and neuropsychiatric assessments, MRIs, EKGs, blood and urine specimen collection, nasal exams and vital signs. Optional lumbar puncture and eye movement assessment.
Frequency of visits: Eight visits over a period of one year, with more frequent visits at the beginning of the study.
Materials needed prior to evaluation: Diagnosis of progressive supranuclear palsy
Costs: No costs will be charged for any of the study procedures. Parking will be validated for Millberry Parking Garage at UCSF for all study visits, and subjects will be reimbursed $50 per visit for meal and travel expenses.