Parkinson DiseasePhase 2NCT05931484
Study to Evaluate the Safety, Tolerability, Efficacy, and PK of FHL-301 in Parkinson's Disease Patients.
A Phase 2 study testing Gemfibrozil in people with Parkinson Disease, run by Forest Hills Lab.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Gemfibrozil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2027to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients must fulfill the following inclusion criteria:
- A diagnosis of clinically established PD in accordance with the Movement Disorder Society (MDS) ClinicalDiagnostic Criteria for PD (Confirmed by DaTscan).
- Each patient must be able and willing to provide signed and dated informed consent prior to the study.
- Female and male patients 40 to 75 years of age inclusive.
- Female patients of childbearing potential must not be pregnant or lactating with a negative serum human chorionic gonadotropin (HCG) pregnancy test result at Screening.
- Female patients of childbearing potential and male patients must use an adequate method of contraception from Screening until completion of the study. Acceptable methods of contraception are barrier methods (male condom, female condom, diaphragm, cervical cap, spermicide, or intrauterine device [IUD]), surgical sterility (documented doctor's report of vasectomy, hysterectomy, and/or bilateral oophorectomy), and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or patient report).
- Treatment naïve patients for PD
- Hoehn and Yahr Stage of 1.0 to 2.0 at Screening
Who cannot join
- Diagnosis is unclear, or a suspicion of other Parkinsonian syndrome exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes, or Huntington's disease.
- The presence of a clear diagnosis of neurodegenerative diseases other than PD
- Have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-PD conditions.
- Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e., bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study.
- Montreal Cognitive Assessment (MoCA) score < 23
- Clinical chemistry assessments that indicate clinically significant major or unstable disease such as: abnormal white or red blood cell count; aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) above 3x the upper limit of normal; or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
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- Pre-existing diagnosis of gastrointestinal diseases which may hamper absorption of study medication, such as liver and gallbladder diseases (e.g., cholangitis and cholestasis), Crohn's disease or ulcerative colitis.
- Female participants that are pregnant or planning to become pregnant.
- Significant neurologic disease such as AD, stroke, brain tumor, multiple sclerosis or seizure disorder.
- Major depression in past 12 months (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria), major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse.
- Use of any investigational agents within 30 days prior to screening.
- Sensitivity, intolerance, or allergies to FHL-301.
- Patient with any history or current evidence of suicidal ideation in the last year.
- Unwilling to complete any planned study assessments.
- Any contraindication for undergoing a Magnetic resonance imaging (MRI) scan of the head.
- Abnormal MRI findings in the mega cisterna, septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or arteriovenous malformations
- Patient has any additional illnesses that in the Investigator's opinion would cause them to be at risk with treatment with FHL-301.
About this study
Official title: A Phase 2, Double-Blind, Multi-Center, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of FHL-301 in Adult Patients With Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Being tested
- Gemfibrozil, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemfibrozilDrug
Oral Solution
PlaceboDrug
Also called Placebo to match Gemfibrozil solution
Daily dose of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Active Receives: Drug: Gemfibrozil |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Unified Parkinson's Disease Rating Scale
Change from Baseline in the Unified Parkinson's Disease Rating Scale Part III (motor examination) at maintenance Week 48 in the modified Full Analysis Set (mFAS) population.
- Motor : range 0-132
- 32 and below is mild and 59 and above is severe.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Nov 2027 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Why it stopped: Has yet to begin and may not so halting to avoid participant outreach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 be randomized 1:1 ratio to receive FHL-301 or Placebo. The study is comprised of two phases: the Dose Titration Phase (DTP) in which participants will be started with a dose of 200 mg BID (30 minutes before the morning and evening meals) and increased during a 3-week treatment period. Patients who complete the DTP 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Hills Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931484
- Sponsor's protocol ID
- FHL-301-001
- Status last verified
- Oct 2024
- First submitted
- 15 Jun 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Multi-Center, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of FHL-301 in Adult Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05931484
- Acronym / sponsor ID
- FHL-301-001
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Has yet to begin and may not so halting to avoid participant outreach
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Forest Hills LabIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2027 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 be randomized 1:1 ratio to receive FHL-301 or Placebo. The study is comprised of two phases: the Dose Titration Phase (DTP) in which participants will be started with a dose of 200 mg BID (30 minutes before the morning and evening meals) and increased during a 3-week treatment period. Patients who complete the DTP 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.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: GemfibrozilActive |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eligible patients must fulfill the following inclusion criteria:
Key exclusion criteria (17 listed)
- Diagnosis is unclear, or a suspicion of other Parkinsonian syndrome exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes, or Huntington's disease.
- The presence of a clear diagnosis of neurodegenerative diseases other than PD
- Have undergone surgery for the treatment of PD (e.g., pallidotomy, deep brain stimulation, fetal tissue transplantation) or have undergone any other brain surgery at any time, even for non-PD conditions.
- Current/history of psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses, i.e., bipolar disorder or MDD, or other psychiatric, neurological or behavioral disorders/symptoms that may interfere with conduct of study.
- Montreal Cognitive Assessment (MoCA) score < 23
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemfibrozilOral Solution | Drug | Active |
| PlaceboAlso: Placebo to match Gemfibrozil solutionDaily dose of Placebo | Drug | Placebo |
Primary outcome
The Unified Parkinson's Disease Rating Scale
Time frame: 52 weeks
Change from Baseline in the Unified Parkinson's Disease Rating Scale Part III (motor examination) at maintenance Week 48 in the modified Full Analysis Set (mFAS) population. * Motor : range 0-132 * 32 and below is mild and 59 and above is severe.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemfibrozil in people with Parkinson Disease, run by Forest Hills Lab.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Unified Parkinson's Disease Rating Scale (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.