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An explorative clinical study to assess the potential of intravenously administered sodium thiosulfate in subjects with primary Raynaud’s phenomenon
EU CTIS ID: 2023-509432-25-00
What this study is testing
To determine the effect of increasing doses of intravenously administered STS on the magnitude of vasodilatation in subjects with Raynaud’s phenomenon
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-45
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to each admission to the clinical research center
- Diagnosed with primary Raynaud’s phenomenon
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Female or male
- No clinically significant abnormality on 12-lead ECG performed at screening
You likely can't join if
- In case of females, subject is pregnant or breast feeding
- Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 3 months prior to the screening visit
- Unsuitable veins for blood sampling;
- Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator
- Presence of abnormal capillary microscopy or other structural vascular abnormalities of forearm, hands, and fingers;
- Patients with concomitant cardiovascular disease like hypertension and previous cerebrovascular events
See the full eligibility criteria
- Age 18-45
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) and grapefruit (juice) from 48 hours (2 days) prior to each admission to the clinical research center
- Diagnosed with primary Raynaud’s phenomenon
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Female or male
- No clinically significant abnormality on 12-lead ECG performed at screening
- Willing to comply with all study related procedures and restrictions;
- Subject is a non-smoker or previous smoker who stopped smoking more than 3 months ago;
- Subjects must have an estimated glomerular filtration rate (eGFR) corrected for their body surface area of ≥90 mL/min based on the CKD-EPI equation, with a single repeat permitted to assess eligibility, if needed;
- All prescribed medication (except for oral contraceptives) must have been stopped at least 14 days prior to each admission to the clinical research center
- Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to screening and each admission to the clinical research center
- In case of females, subject is pregnant or breast feeding
- Subject has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 3 months prior to the screening visit
- Unsuitable veins for blood sampling;
- Significant and/or acute illness within 5 days prior to drug administration that may impact safety assessments, in the opinion of the Investigator
- Presence of abnormal capillary microscopy or other structural vascular abnormalities of forearm, hands, and fingers;
- Patients with concomitant cardiovascular disease like hypertension and previous cerebrovascular events
- Asthma patients
- Presence of auto-antibodies associated with secondary causes of Raynaud’s phenomenon;
- Any secondary disease associated with Raynaud’s phenomenon i.e. systemic autoimmune disease, other structural vascular or systemic diseases associated with Raynaud’s;
- Any invasive radiological, anesthesiologic or surgical procedure performed for Raynaud’s phenomenon
- History of digital ulcers
- History of severe trauma to forearm, hands and fingers
- Subject is mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last year;
- Subject is unable to refrain from or anticipates the use of any medication throughout the study
- Subject consumes excessive amounts of alcohol, defined as greater than 21 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer (284 mL), wine (125 mL), or distilled spirits (25 mL) per week;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.