Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation
NCT ID: NCT02149160
Last Updated: 2016-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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FRM-0334; Arm 1
low dose, Capsule, Once Daily, Day 1 through Day 28
FRM-0334
FRM-0334; Arm 2
high dose, Capsule, Once Daily, Day 1 through Day 28
FRM-0334
Placebo Comparator; Arm 3
Placebo, Capsule, Once Daily, Day 1 through Day 28
Placebo
Interventions
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FRM-0334
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* Females who are pregnant, breastfeeding, or planning to become pregnant during the study
21 Years
75 Years
ALL
No
Sponsors
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FORUM Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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UCSF Memory and Aging Center
San Francisco, California, United States
Compass Research, LLC
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Perelman School of Medicine, University of Pennsylvania
Philadelphia, Pennsylvania, United States
University Hospitals Leuven
Leuven, , Belgium
CHU Bordeaux Hospital Pellegrin
Bordeaux, , 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, South Holland, Netherlands
The National Hospital for Neurology and Neuroscience
London, , United Kingdom
Countries
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References
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Ljubenkov PA, Edwards L, Iaccarino L, La Joie R, Rojas JC, Koestler M, Harris B, Boeve BF, Borroni B, van Swieten JC, Grossman M, Pasquier F, Frisoni GB, Mummery CJ, Vandenberghe R, Le Ber I, Hannequin D, McGinnis SM, Auriacombe S, Onofrj M, Goodman IJ, Riordan HJ, Wisniewski G, Hesterman J, Marek K, Haynes BA, Patzke H, Koenig G, Hilt D, Moebius H, Boxer AL. Effect of the Histone Deacetylase Inhibitor FRM-0334 on Progranulin Levels in Patients With Progranulin Gene Haploinsufficiency: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2125584. doi: 10.1001/jamanetworkopen.2021.25584.
Other Identifiers
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2014-001489-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FRM-0334-002
Identifier Type: -
Identifier Source: org_study_id
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