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

F

FORUM Pharmaceuticals

Status and phase

Unknown
Phase 2

Conditions

Granulin Mutation

Treatments

Drug: Placebo
Drug: FRM-0334

Study type

Interventional

Funder types

Industry

Identifiers

NCT02149160
2014-001489-85 (EudraCT Number)
FRM-0334-002

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 3 patient groups, including a placebo group

FRM-0334; Arm 1
Experimental group
Description:
low dose, Capsule, Once Daily, Day 1 through Day 28
Treatment:
Drug: FRM-0334
FRM-0334; Arm 2
Experimental group
Description:
high dose, Capsule, Once Daily, Day 1 through Day 28
Treatment:
Drug: FRM-0334
Placebo Comparator; Arm 3
Placebo Comparator group
Description:
Placebo, Capsule, Once Daily, Day 1 through Day 28
Treatment:
Drug: Placebo

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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