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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

NCT07322887 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-31

No results posted yet for this study

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. 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

Conditions

  • Parkinson's Disease (PD)

Interventions

DRUG

SUL-238 (1500 mg t.i.d.) film-coated tablets

Oral treatment with high dose SUL-238 for 28 days

DRUG

SUL-238 (500 mg t.i.d.) film-coated tablets

Oral treatment with low dose SUL-238 for 28 days

DRUG

Placebo

Oral treatment with placebo for 28 days

Sponsors & Collaborators

  • Sulfateq B.V.

    collaborator UNKNOWN

  • GEN İlaç ve Sağlık Ürünleri A.Ş.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-02
Primary Completion
2027-03-01
Completion
2027-05-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07322887 on ClinicalTrials.gov