NCT02149160

Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: FORUM Pharmaceuticals Inc · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Granulin Mutation

Interventions

Type	Name	Description
DRUG	FRM-0334
DRUG	Placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-08-01
• First posted: 2014-05-29
• Last updated: 2016-03-23

Locations

13 sites across 6 countries: United States, Belgium, France, Italy, Netherlands, United Kingdom