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Unknown

FRM-0334 for Frontotemporal Dementia

Phase 2
Waitlist Available
Research Sponsored by FORUM Pharmaceuticals Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow capsules
Genotyped positive for a FTD-GRN mutation, and aware of it
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 28 or early termination

Summary

This trial is testing a new drug for people with a specific type of dementia caused by a granulin mutation. The goal is to see if the drug is safe and effective.

Who is the study for?
This trial is for adults aged 21-75 with prodromal to moderate frontotemporal dementia who have a granulin mutation. Participants must be in stable health, able to swallow capsules, and live in a setting that doesn't require constant nursing care. Pregnant or breastfeeding women are excluded.
What is being tested?
The study is testing the safety and effects of FRM-0334 on individuals with frontotemporal dementia due to granulin mutation. It compares FRM-0334 against a placebo (a substance with no therapeutic effect) to see if there's any improvement or change in symptoms.
What are the potential side effects?
While specific side effects aren't listed, common ones may include digestive issues, headaches, dizziness, potential allergic reactions, and other drug-related adverse events which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can swallow pills.
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I know I have a genetic mutation linked to my condition.
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I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major health or mental issues that are not under control.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 28 or early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 28 or early termination for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the safety and tolerability of FRM-0334
Secondary study objectives
Assess the pharmacodynamic effects of FRM-0334 on the change from baseline in cerebrospinal fluid (CSF) concentrations of PGRN after 28 days
Characterize the CSF concentrations of FRM-0334 and metabolites following once daily dosing for 28 days
Plasma

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: FRM-0334; Arm 2Experimental Treatment1 Intervention
high dose, Capsule, Once Daily, Day 1 through Day 28
Group II: FRM-0334; Arm 1Experimental Treatment1 Intervention
low dose, Capsule, Once Daily, Day 1 through Day 28
Group III: Placebo Comparator; Arm 3Placebo Group1 Intervention
Placebo, Capsule, Once Daily, Day 1 through Day 28

Find a Location

Who is running the clinical trial?

FORUM Pharmaceuticals IncLead Sponsor
18 Previous Clinical Trials
4,948 Total Patients Enrolled

Media Library

FRM-0334 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT02149160 — Phase 2
Granulin Mutation Research Study Groups: Placebo Comparator; Arm 3, FRM-0334; Arm 2, FRM-0334; Arm 1
Granulin Mutation Clinical Trial 2023: FRM-0334 Highlights & Side Effects. Trial Name: NCT02149160 — Phase 2
FRM-0334 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02149160 — Phase 2
~3 spots leftby Dec 2025
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