Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients.

Sponsor
Forest Hills Lab
Study ID
NCT05931484
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gemfibrozil — DRUG
    Oral Solution
  • Placebo — DRUG
    Daily dose of Placebo

Study Details

This is a phase 2, double-blind, multi-center, placebo-controlled clinical study to evaluate the safety, tolerability, efficacy, and PK of FHL-301 in adult patients with early-stage PD. Following screening, qualifying patients who meet all inclusion and exclusion criteria will enter the study and be randomized 1:1 to receive FHL-301 or Placebo at a starting dose of 200 mg BID (30 minutes before the morning and evening meals) during the 3-week titration period. To determine the tolerance of each participant for FHL-301, titration will increase by 200 mg BID every week until the maximum dose of 600 mg BID or the highest tolerated dose of 1200 mg daily is reached and maintained for 1 week. Thereafter, patients who complete the dose Titration Phase of the study will enter the Maintenance Phase and remain on the final titrated dose for up to 48 weeks post titration. If at any stage during the titration phase the participant cannot tolerate the increased dose, the dose will be decreased by 100 mg BID weekly until the highest tolerated dose is reached.

Key Dates

First listed
Jul 5, 2023
Start date
Nov 1, 2027
Status verified
Oct 2024
Primary completion
Nov 1, 2028
Completion
Nov 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
    Active
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

The Unified Parkinson's Disease Rating Scale [ Time Frame: 52 weeks ]

Central Contacts

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