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Eligibility
for people ages 21 years to 75 years
Location
at San Francisco, California and other locations
Dates
study started

Description

Summary

The purposes of this study are to investigate the safety, tolerability, and pharmacodynamics of FRM-0334 in subjects with prodromal to moderate frontotemporal dementia with granulin mutation.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Phase 2a Safety, Tolerability, and Pharmacodynamic Study of Two Doses of an Histone Deacetylase Inhibitor (FRM-0334) in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

Keywords

Granulin Mutation Histone deacetylase inhibitor Frontotemporal dementia Granulin Histone Deacetylase Inhibitors

Eligibility

You can join if…

Open to people ages 21 years to 75 years

  • Male or female ages aged ≥21 and ≤75 years
  • Genotyped positive for a FTD-GRN mutation, and aware of it
  • Prodromal to moderate FTD-GRN
  • Resides in a stable living situation, living at home, senior residential setting, or an institutional setting without the need for continuous (ie, 24-hour) nursing care
  • Proficiency (oral and written) in the language in which study-related documents,including the ICF and standardized tests, will be administered
  • Able to swallow capsules
  • Be in good general health, willing and able to comply with the protocol requirements,and expected to complete the study as designed (in the judgment of the investigator)

You CAN'T join if...

  • Clinically significant abnormalities on physical examination, medical history, ECG,vital signs, laboratory values, or unstable medical or psychiatric illness
  • Females who are pregnant, breastfeeding, or planning to become pregnant during the study

Locations

  • Compass Research, LLC
    Orlando, Florida, USA
  • Massachusetts General Hospital
    Boston, Massachusetts, USA
  • Mayo Clinic
    Rochester, Minnesota, USA
  • Perelman School of Medicine, University of Pennsylvania
    Philadelphia, Pennsylvania, USA
  • University Hospitals Leuven
    Leuven, Belgium
  • CHU Bordeaux Hospital Pellegrin
    Bordeaux Cedex, France
  • CHU Rouen, Charles Nicolle Hospital
    Rouen, France
  • IRCCS - Centro S. Giovanni di Dio FateBeneFratelli
    Brescia, Italy
  • Neurological Clinic, University of Brescia, AO Civil Hospital of Brescia
    Brescia, Italy
  • Fondazione Universita Gabriele D'Annunzio di Chieti
    Chieti Scalo, Italy
  • Erasmus Medical Center
    Rotterdam, Zuid-Holland, Netherlands
  • The National Hospital for Neurology and Neuroscience
    London, United Kingdom

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
FORUM Pharmaceuticals Inc
ID
NCT02149160
Phase
Phase 2
Study Type
Interventional
Last Updated
May 2015