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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524674-42-00

Enrollment

Registered

2026-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson’s Disease

Brief summary

The (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 (ROIs): • Putamen • Substantia Nigra • Motor Cortex

Detailed description

Mean change from baseline to Week 4 in each active dose group as compared to placebo in the predefined mitochondria-related plasma targeted metabolomics and quantitative proteomics., To assess safety and tolerability of SUL-238 Parkinson’s Disease Patients. a- Frequency, seriousness and intensity of adverse events (AEs). b- Changes in safety laboratory measurements, c- Clinically significant changes in vital signs d- Clinically significant changes in electrocardiogram (ECG) e- Clinically significant changes in physical and neurological examination.

Interventions

DRUGSUL-238

DRUGIdentical to test product except without active substance

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The (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 (ROIs): • Putamen • Substantia Nigra • Motor Cortex	—

Secondary

Measure	Time frame
Mean change from baseline to Week 4 in each active dose group as compared to placebo in the predefined mitochondria-related plasma targeted metabolomics and quantitative proteomics., To assess safety and tolerability of SUL-238 Parkinson’s Disease Patients. a- Frequency, seriousness and intensity of adverse events (AEs). b- Changes in safety laboratory measurements, c- Clinically significant changes in vital signs d- Clinically significant changes in electrocardiogram (ECG) e- Clinically significant changes in physical and neurological examination.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 14, 2026