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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 28 or early termination

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 28 or early termination

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the pharmacodynamic (PD) effects of FRM-0334 on the change from baseline in plasma concentrations of progranulin (PGRN) after 28 days

Evaluate the safety and tolerability of FRM-0334

Secondary outcome measures

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

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does your research team plan to enroll any test subjects that are middle-aged or beyond?

"The age restrictions for this study are that participants must be over 21 and under 75 years old."

Answered by AI

Are we still enrolling participants for this research project?

"According to the listing on clinicaltrials.gov, this study has closed to recruitment. The trial was first posted on October 1st, 2014 and last updated on March 22nd, 2016. There are 433 other trials that patients can participate in at this time."

Answered by AI

What are the potential side effects of FRM-0334?

"FRM-0334's safety is supported by Phase 2 trial data, meaning that while there isn't evidence of its efficacy yet, it has been shown to be safe. Our team at Power gives it a score of 2."

Answered by AI

Is this research being done in more than one state?

"Multiple sites across the country are enrolling patients for this trial, including Compass Research in Orlando, Mayo Clinic in Rochester, and Massachusetts General Hospital in Boston. In total, there are 5 locations recruiting participants."

Answered by AI

Could I potentially take part in this research?

"This trial is recruiting 30 people, within the ages of 21 and 75 who currently have aphasia, primary progressive. It is important that participants also meet the following criteria: Prodromal to moderate FTD-GRN, Proficiency (oral and written) in the language in which study-related documents, including the ICF and standardized tests, will be administered, Male or female ages aged ≥21 and ≤75 years, Genotyped positive for a FTD-GRN mutation, and aware of it, Resides in a stable living situation, living at home, senior residential setting, or an institutional setting"

Answered by AI

Recent research and studies

JAMA Network OpenJournal

Effect of the Histone Deacetylase Inhibitor FRM-0334 on Progranulin Levels in Patients with Progranulin Gene Haploinsufficiency

Ljubenkov, Peter A., Lauren Edwards, Leonardo Iaccarino, Renaud La Joie, Julio C. Rojas, Mary Koestler, Baruch Harris, et al.. 2021. “Effect of the Histone Deacetylase Inhibitor FRM-0334 on Progranulin Levels in Patients with Progranulin Gene Haploinsufficiency”. JAMA Network Open. American Medical Association (AMA). doi:10.1001/jamanetworkopen.2021.25584.

clinicaltrials.govStudy

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

2014. "Study to Assess the Safety, Tolerability, and Pharmacodynamic (PD) Effects of FRM-0334 in Subjects With Prodromal to Moderate Frontotemporal Dementia With Granulin Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02149160.

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