Parkinson's Disease (PD)Phase 2SHEPHERDNCT07322887
A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreated Parkinson's Disease
A Phase 2 study testing SUL-238 (1500 mg t.i.d.) film-coated tablets and SUL-238 (500 mg t.i.d.) film-coated tablets in people with Parkinson's Disease (PD), run by GEN İlaç ve Sağlık Ürünleri A.Ş. at 1 site in Netherlands.
Trial summary
The main goal of the study is to investigate how well the new drug SUL-238 works in Parkinson's Disease (PD). This is done by means of an MRS scan. An MRS scan is similar to a regular MRI scan. It will also learn about the safety of new drug SUL-238. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- SUL-238 (1500 mg t.i.d.) film-coated tablets and SUL-238 (500 mg t.i.d.) film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 May 2026to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated Parkinson's Disease (PD) patients diagnosed in accordance with the UK PDS Brain Bank Criteria for the diagnosis of PD. Patients must have bradykinesia and at least one of the following:
- muscular rigidity
- rest tremor (4-6 Hz)
- postural instability unrelated to primary visual, cerebellar, vestibular or proprioceptive dysfunction.
- The duration of PD since diagnosis is ≤ 1 year.
- Patients with Modified Hoehn and Yahr stage ≤ 2.0.
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- Patients with Montreal Cognitive Assessment (MOCA) score of ≥22.
- Men and women aged ≥40 years at screening.
- Able to understand the nature of the study and provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures.
- Able to complete all study related testing and evaluations.
- Patients must be, in the opinion of the Investigator, able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant.
- Men and women of child-bearing potential with partners of child-bearing potential must agree to use highly effective contraception. For male patients, contraception should continue for 3 months after the last dose of investigational medicinal product (IMP, one spermatic cycle). For female patients, contraception should continue for 6 months after the last dose of IMP (one oocyte cycle).
- Women of non-childbearing potential must be post-menopausal (the last menstrual period was at least 12 months ago, and follicle-stimulating hormone [FSH] at screening confirms post-menopausal status), or have no uterus, ovaries, or fallopian tubes (or have their fallopian tubes tied). All women must have a negative pregnancy test result before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
Who cannot join
- Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
- Any history of intellectual disability or psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, except a history of mild depression/anxiety that has been resolved for at least the past 3 months.
- A positive answer to questions 3 through 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
- A positive Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus (HIV) antibody test at screening.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN) at screening or between screening and first dose administration.
- Received or used an investigational product (including placebo) or device within the following time period prior to day -1 in the current study: 90 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
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- Use of non-prescription drugs, vitamins, herbal, and dietary supplements which has potential to influence the mitochondrial function (such as coenzyme Q10, carnitine, creatine, lipoic acid and vitamin E) within 30 days prior to day -1.
- Use of drugs which are strong inhibitors of CYP3A4 or CYP3A4 substrates with narrow therapeutic index within 30 days prior to day -1.
- History of clinically significant sensitivity to any of the study medications, or components thereof or a history of drug or other allergies that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
- Women with a positive pregnancy test, are lactating, or are planning to become pregnant during the study or within 6 months of the end of this study.
- A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion. Patients with a history of cholecystectomy should be excluded.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic (other than PD) abnormality.
- At screening, any clinically significant abnormalities in rhythm, conduction, or morphology of the resting 12-lead ECG.
- A clinically significant vital signs abnormality at screening or day -1, as determined by the investigator in accordance with the Dutch General Practitioner Guidelines (NHG Standards), corresponding to higher than 160 mm Hg systolic and 110 mm Hg diastolic blood pressure. Participants with a systolic blood pressure <90 mmHg or a diastolic blood pressure <50 mmHg will also be excluded.
- In the opinion of the Investigator or Medical Monitor, the patient is unlikely to comply with the protocol or is unsuitable for any reason, e.g., known issues with ability to swallow tablets.
- Women of child-bearing potential (WOCBP), or men, who are unwilling or unable to use accepted methods of birth control for up to 6 months following study participation.
- Contraindications for undergoing an MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
CTC Netherlands BV
Groningen, 9713 GZ
Mariska Beukers, (+31) 503055482, mariska.beukers@ctc-netherlands.com
Teus van Laar, Prof Dr
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled, Single-Center Study to Assess the Effects of SUL-238 on High Energy Phosphates With Magnetic Resonance Spectroscopy (³¹P-MRS) in Patients With Early, Untreated Parkinson's Disease ("SHEPHERD" STUDY)
The main goal of the study is to investigate how well the new drug SUL-238 works in Parkinson's Disease (PD). This is done by means of an MRS scan. An MRS scan is similar to a regular MRI scan. It will also learn about the safety of new drug SUL-238. The main questions it aims to answer are:
- Does new drug SUL-238 improve the mitochondrial function in patients with Parkinson's Disease (PD)?
- What medical problems do participants have when taking new drug SUL-238?
Read more
Researchers will compare new drug SUL-238 to a placebo (a look-alike substance that contains no drug) to see if SUL-238 works to improve mitochondrial function in patients with PD.
Participants will:
- Take new drug SUL-238 or a placebo every day for 28 days
- Visit the clinic once every 2 weeks for checkups and tests during the treatment period and finally 28 days after the last dose of SUL-238
- Keep a diary of their symptoms and the number of times they use oral new drug SUL-238
Read the detailed description
Two different oral doses of SUL-238 (1500 mg t.i.d. or 500 mg t.i.d) or placebo will be administered to patients with early, untreated Parkinson's Disease (PD), aged ≥40 years. Patients will be randomly assigned to one of the 3 groups using 1:1:1 randomization, each group will consist of 15 patients. Patients will be stratified based on their sex in to ensure similar distribution of both sexes in each group. Drop-outs will be replaced with new patients to reach 15 patients in each group. Study drugs will be administered after fasting for a minimum of 1 hour prior to dosing and 1 hour after the administration of the study medication. However, for the third dose on Day 1 and the first dose on Day 14, subjects are required to fast for 4 hours due to Safety Lab assessments. Additionally, the first dose on Day 1 and Day 28, for which a fasting period of 8 hours is required, as the same conditions for 31P-MRS are requested to exclude any interference with food intake. Therefore, On Day 28 subjects should arrive at the unit in a fasted state (following the meal 1 hour after the third dose on Day 27) and remain fasted until completion of the 31P-MRS. Only morning dose will be given on day 28, there will be no dosing between days 29 and 56.
There will be three study periods per treatment group:
- A maximum of four-week screening period (Screening Period)
- A four-week treatment period (Treatment Period)
- A four-week follow-up period (End-of-Study Assessment)
Patients will be visiting the study center in the morning, in total five times for study assessments and collections of blood samples until day 56. Blood samples will be collected on days 1, 14, 28, and 56 (On day 1 [pre-dose baseline, post-dose at 1 hr], and days 14 [pre-dose], 28 [post-morning dose at 1 hr and 4 hr]).
Patients who agreed to provide CSF in each group will give one CSF sample on day 28 at 4 hours post-morning dose.
Voxel Metabolite Measurements:
MRI/MRS scans will be conducted on a Siemens 3 MAGNETOM Cima.X scanner located at the at the UMCG. Patients will undergo 31P-MRS scans to measure concentrations of the following mitochondria-related brain metabolites: ATP, phosphocreatine and inorganic phosphate, as well as membrane related phospholipids PME and PDE.
Preparation: A 31P/1H T/R head coil will be used. The head of the patient will be positioned at the center of the coil. Prior to 31P-MRS, T1 and T2 weighted structural images are acquired for reference purposes during voxel placement.
31P-MRS scans: First, a dynamic series of the whole brain will be acquired for the duration of 15 minutes. During this period, three epochs of three minutes rest are interleaved by two epochs of three minutes of paced, alternating fist clenching using both hands. Second, the MRS scan during rest is based on a 3D-CSI acquisition with a duration of 15 minutes. This allows localisation of the 31P-spectra bilaterally for precentral gryrus, substantia nigra, as well as the putamen with sufficient signal to noise ratio for further analysis.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- SUL-238 (1500 mg t.i.d.) film-coated tablets, SUL-238 (500 mg t.i.d.) film-coated tablets, Placebo
- Keywords
- Phase 2, SUL-238, Mitochondrial function, Magnetic Resonance Spectroscopy, MRS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUL-238 (1500 mg t.i.d.) film-coated tabletsDrug
Oral treatment with high dose SUL-238 for 28 days
SUL-238 (500 mg t.i.d.) film-coated tabletsDrug
Oral treatment with low dose SUL-238 for 28 days
PlaceboDrug
Oral treatment with placebo for 28 days
| Study group | Role | What they receive |
|---|---|---|
| SUL-238 high dose | Experimental | SUL-238 (1500 mg t.i.d.) Receives: Drug: SUL-238 (1500 mg t.i.d.) film-coated tablets |
| SUL-238 low dose | Experimental | SUL-238 (500 mg t.i.d.) Receives: Drug: SUL-238 (500 mg t.i.d.) film-coated tablets |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effect of SUL-238 on mitochondria-related brain metabolites in Parkinson's Disease (PD) Patients
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the concentration of mitochondria-related brain metabolites (ATP, phosphocreatine and inorganic phosphate), as measured by ³¹P-Magnetic Resonance Spectroscopic (MRS) imaging, in the following regions of interest: 1. Putamen, 2. Substantia Nigra, 3. Motor Cortex
Measured: At baseline and end of treatment at 4 weeks
Secondary outcomes (3)
Assessment of the effect of SUL-238 treatment on systemic biomarkers of mitochondrial function and associated pathways in Parkinson's Disease (PD) patients by predefined mitochondria related plasma targeted metabolomics
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the circulating levels of established indicators of mitochondrial dysfunction such as lactate, pyruvate and lysophosphatidylcholine
Measured: At baseline and end of treatment at 4 weeks
Assessment of the effect of SUL-238 treatment on systemic biomarkers of mitochondrial function and associated pathways in Parkinson's Disease (PD) patients by predefined mitochondria related plasma targeted proteomics
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the circulating levels of established indicators of mitochondrial dysfunction such as cell-free Cytochrome c, creatinine and succinate dehydrogenase (SDH)
Measured: At baseline and end of treatment at 4 weeks
Assessment of safety and tolerability of SUL-238 in Parkinson's Disease (PD) Patients
Safety and tolerability of SUL-238 will be assessed by the number of participants;
- with adverse events,
- with abnormal laboratory test results,
- abnormal vital signs,
- abnormal electrocardiogram,
- abnormal physical and neurological examination
Measured: From enrollment to the end of follow-up period at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start21 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GEN İlaç ve Sağlık Ürünleri A.Ş.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sulfateq B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322887
- Sponsor's protocol ID
- GN-002
- Other IDs
- 2025-524674-42-00, 2025
- Acronym
- SHEPHERD
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-Controlled, Single-Center Study to Assess the Effects of SUL-238 on High Energy Phosphates With Magnetic Resonance Spectroscopy (³¹P-MRS) in Patients With Early, Untreated Parkinson's Disease ("SHEPHERD" STUDY)
- ClinicalTrials.gov ID
- NCT07322887
- Acronym / sponsor ID
- SHEPHERD / GN-002
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Phase 2, SUL-238, Mitochondrial function, Magnetic Resonance Spectroscopy, MRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- GEN İlaç ve Sağlık Ürünleri A.Ş.Industry (pharma, biotech, devices)
- Collaborators
- Sulfateq B.V.
- Study start
- 21 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
The main goal of the study is to investigate how well the new drug SUL-238 works in Parkinson's Disease (PD). This is done by means of an MRS scan. An MRS scan is similar to a regular MRI scan. It will also learn about the safety of new drug SUL-238. The main questions it aims to answer are:
- Does new drug SUL-238 improve the mitochondrial function in patients with Parkinson's Disease (PD)?
- What medical problems do participants have when taking new drug SUL-238?
Researchers will compare new drug SUL-238 to a placebo (a look-alike substance that contains no drug) to see if SUL-238 works to improve mitochondrial function in patients with PD.
Participants will:
- Take new drug SUL-238 or a placebo every day for 28 days
- Visit the clinic once every 2 weeks for checkups and tests during the treatment period and finally 28 days after the last dose of SUL-238
- Keep a diary of their symptoms and the number of times they use oral new drug SUL-238
Detailed description
Two different oral doses of SUL-238 (1500 mg t.i.d. or 500 mg t.i.d) or placebo will be administered to patients with early, untreated Parkinson's Disease (PD), aged ≥40 years. Patients will be randomly assigned to one of the 3 groups using 1:1:1 randomization, each group will consist of 15 patients. Patients will be stratified based on their sex in to ensure similar distribution of both sexes in each group. Drop-outs will be replaced with new patients to reach 15 patients in each group. Study drugs will be administered after fasting for a minimum of 1 hour prior to dosing and 1 hour after the administration of the study medication. However, for the third dose on Day 1 and the first dose on Day 14, subjects are required to fast for 4 hours due to Safety Lab assessments. Additionally, the first dose on Day 1 and Day 28, for which a fasting period of 8 hours is required, as the same conditions for 31P-MRS are requested to exclude any interference with food intake. Therefore, On Day 28 subjects should arrive at the unit in a fasted state (following the meal 1 hour after the third dose on Day 27) and remain fasted until completion of the 31P-MRS. Only morning dose will be given on day 28, there will be no dosing between days 29 and 56.
There will be three study periods per treatment group:
- A maximum of four-week screening period (Screening Period)
- A four-week treatment period (Treatment Period)
- A four-week follow-up period (End-of-Study Assessment)
Patients will be visiting the study center in the morning, in total five times for study assessments and collections of blood samples until day 56. Blood samples will be collected on days 1, 14, 28, and 56 (On day 1 [pre-dose baseline, post-dose at 1 hr], and days 14 [pre-dose], 28 [post-morning dose at 1 hr and 4 hr]).
Patients who agreed to provide CSF in each group will give one CSF sample on day 28 at 4 hours post-morning dose.
Voxel Metabolite Measurements:
MRI/MRS scans will be conducted on a Siemens 3 MAGNETOM Cima.X scanner located at the at the UMCG. Patients will undergo 31P-MRS scans to measure concentrations of the following mitochondria-related brain metabolites: ATP, phosphocreatine and inorganic phosphate, as well as membrane related phospholipids PME and PDE.
Preparation: A 31P/1H T/R head coil will be used. The head of the patient will be positioned at the center of the coil. Prior to 31P-MRS, T1 and T2 weighted structural images are acquired for reference purposes during voxel placement.
31P-MRS scans: First, a dynamic series of the whole brain will be acquired for the duration of 15 minutes. During this period, three epochs of three minutes rest are interleaved by two epochs of three minutes of paced, alternating fist clenching using both hands. Second, the MRS scan during rest is based on a 3D-CSI acquisition with a duration of 15 minutes. This allows localisation of the 31P-spectra bilaterally for precentral gryrus, substantia nigra, as well as the putamen with sufficient signal to noise ratio for further analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SUL-238 high dose | Experimental | Drug: SUL-238 (1500 mg t.i.d.) film-coated tabletsSUL-238 (1500 mg t.i.d.) |
| SUL-238 low dose | Experimental | Drug: SUL-238 (500 mg t.i.d.) film-coated tabletsSUL-238 (500 mg t.i.d.) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Untreated Parkinson's Disease (PD) patients diagnosed in accordance with the UK PDS Brain Bank Criteria for the diagnosis of PD. Patients must have bradykinesia and at least one of the following:
- The duration of PD since diagnosis is ≤ 1 year.
- Patients with Modified Hoehn and Yahr stage ≤ 2.0.
- Patients with Montreal Cognitive Assessment (MOCA) score of ≥22.
- Men and women aged ≥40 years at screening.
Key exclusion criteria (17 listed)
- Atypical parkinsonism, including that due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
- Any history of intellectual disability or psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, except a history of mild depression/anxiety that has been resolved for at least the past 3 months.
- A positive answer to questions 3 through 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening.
- A positive Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus (HIV) antibody test at screening.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal (ULN) at screening or between screening and first dose administration.
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 |
|---|---|---|
| SUL-238 (1500 mg t.i.d.) film-coated tabletsOral treatment with high dose SUL-238 for 28 days | Drug | SUL-238 high dose |
| SUL-238 (500 mg t.i.d.) film-coated tabletsOral treatment with low dose SUL-238 for 28 days | Drug | SUL-238 low dose |
| PlaceboOral treatment with placebo for 28 days | Drug | Placebo |
Primary outcome
Assessment of the effect of SUL-238 on mitochondria-related brain metabolites in Parkinson's Disease (PD) Patients
Time frame: At baseline and end of treatment at 4 weeks
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the concentration of mitochondria-related brain metabolites (ATP, phosphocreatine and inorganic phosphate), as measured by ³¹P-Magnetic Resonance Spectroscopic (MRS) imaging, in the following regions of interest: 1. Putamen, 2. Substantia Nigra, 3. Motor Cortex
3 secondary outcomes
Assessment of the effect of SUL-238 treatment on systemic biomarkers of mitochondrial function and associated pathways in Parkinson's Disease (PD) patients by predefined mitochondria related plasma targeted metabolomics
Time frame: At baseline and end of treatment at 4 weeks
Assessment of the effect of SUL-238 treatment on systemic biomarkers of mitochondrial function and associated pathways in Parkinson's Disease (PD) patients by predefined mitochondria related plasma targeted proteomics
Time frame: At baseline and end of treatment at 4 weeks
Assessment of safety and tolerability of SUL-238 in Parkinson's Disease (PD) Patients
Time frame: From enrollment to the end of follow-up period at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUL-238 (1500 mg t.i.d.) film-coated tablets and SUL-238 (500 mg t.i.d.) film-coated tablets in people with Parkinson's Disease (PD), run by GEN İlaç ve Sağlık Ürünleri A.Ş. at 1 site in Netherlands.
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 13 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadir Ulu, MD, PhD ((+90) 5334510385, n.ulu@genilac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effect of SUL-238 on mitochondria-related brain metabolites in Parkinson's Disease (PD) Patients (time frame: At baseline and end of treatment at 4 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 17 Aug 2026.