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Sodium Thiosulfate Pentahydrate

Clinical trials are studying Sodium Thiosulfate Pentahydrate in people with ectopic calcifications, ectopic ossifications, and primary Raynaud’s phenomenon. These studies aim to evaluate whether treatment can improve the targeted condition and how the body responds over time. The trials include adults with these specific diseases and are in Phase 2.

Table of Contents

Trial overview

Two authorised Phase 2 clinical trials are investigating Sodium Thiosulfate Pentahydrate.[1][2] One trial studies people with ectopic calcifications or ectopic ossifications, and the other studies people with primary Raynaud’s phenomenon.[1][2]

Study in calcifications and ossifications

NCT03582800 is a pilot study of subcutaneous injections of Sodium Thiosulfate Pentahydrate for ectopic calcifications or ossifications.[1] The trial includes patients with ectopic ossification secondary to iPPSD2, ectopic calcification secondary to dermatomyositis, or ectopic calcification secondary to systemic sclerosis.[1]

This study uses a 6-month run-in period, followed by 6 months of treatment with a 10% STS solution injected locally.[1] In simple terms, the researchers first observe the condition, then give the study treatment to see whether the abnormal calcium or bone changes improve.[1]

Study in primary Raynaud’s phenomenon

The second study, 2023-509432-25-00, is an explorative clinical study in subjects with primary Raynaud’s phenomenon.[2] It looks at the potential of intravenously administered Sodium Thiosulfate Pentahydrate, meaning the treatment is given into a vein.[2]

The brief summary says the study is designed to determine the effect of increasing doses on the magnitude of vasodilatation, which means how much the blood vessels widen.[2] This is important because Raynaud’s phenomenon affects blood flow in the hands.[2]

What the trials measure

The calcification and ossification trial measures the percentage change in volume of treated lesions between month 6 and month 12, using CT-scan measurements.[1] A lesion is the area being treated or studied.[1]

The Raynaud’s trial measures the area under the cooling and rewarming curve and the mean ischemic time of one hand using photo-electric plethysmography, or PPG.[2] It also measures peripheral blood perfusion in the same hand using a FLIR thermography system.[2]

These endpoints help researchers see whether the treatment changes tissue size in one study and blood flow in the other.[1][2]

Who can participate

The first trial is for patients with ectopic ossification secondary to iPPSD2, or ectopic calcification secondary to dermatomyositis or systemic sclerosis.[1] The second trial is for subjects with primary Raynaud’s phenomenon.[2]

These trials are focused on specific patient groups, so not everyone with a similar symptom would qualify.[1][2]

Study design and phases

Both studies are interventional, which means the researchers give a treatment and then measure the results.[1][2] Both are in Phase 2 and are authorised.[1][2]

The first study plans to enroll 40 people, and the second plans to enroll 12 people.[1][2] The first uses subcutaneous injections, while the second uses intravenous administration.[1][2]

Trial ID Phase Condition studied Status Enrollment
NCT03582800 Phase 2 Ectopic calcifications or ossifications linked to dermatomyositis, systemic sclerosis, or iPPSD2 Authorised 40
2023-509432-25-00 Phase 2 Primary Raynaud’s phenomenon Authorised 12

FAQ

  • What is being studied in trials of Sodium Thiosulfate Pentahydrate? The trials are studying whether Sodium Thiosulfate Pentahydrate can help with ectopic calcifications, ectopic ossifications, and Raynaud’s phenomenon. They measure changes in the affected tissue or blood flow to see if treatment has an effect.
  • Who can take part in these clinical trials? People with ectopic ossification from iPPSD2, ectopic calcification from dermatomyositis, ectopic calcification from systemic sclerosis, or primary Raynaud’s phenomenon may be eligible. Each trial has its own entry rules.
  • What phase are these trials in? Both trials are in Phase 2. This phase looks at whether the treatment may work and continues to collect safety and response information.
  • How is Sodium Thiosulfate Pentahydrate given in these studies? One study uses local subcutaneous injections, which means injections under the skin. The other study uses intravenous administration, which means the treatment is given into a vein.
  • What do the trials measure as results? One trial measures the change in volume of calcifications or ossifications on CT scans. The other measures blood flow and time to recovery during cooling and rewarming tests.

Ongoing Clinical Trials on Sodium Thiosulfate Pentahydrate

  • Study of Intravenous Sodium Thiosulfate for Treatment of Primary Raynaud’s Phenomenon

    Recruiting

    2 1 1 1
    Investigated drugs:
    The Netherlands

  • Study of Sodium Thiosulfate Injections for Patients with Ectopic Calcifications or Ossifications from Dermatomyositis, Systemic Sclerosis, or iPPSD2

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Phase 2: A mid-stage clinical trial that checks whether a treatment may work in a specific condition and gathers more information about how people respond.
  • Interventional study: A study where researchers give a treatment or procedure to see what happens.
  • Ectopic calcification: Calcium buildup in places where it is not supposed to be, such as in soft tissues.
  • Ectopic ossification: Bone formation in soft tissues or other places outside the normal skeleton.
  • Dermatomyositis: A disease that can affect the muscles and skin and, in this trial, is linked to calcification.
  • Systemic sclerosis: A disease that can cause hardening of the skin and other body changes and, in this trial, is linked to calcification.
  • iPPSD2: A rare condition mentioned in the trial as a cause of ectopic ossification.
  • Raynaud’s phenomenon: A condition where blood flow to the fingers or hands becomes reduced, often during cold exposure.
  • CT-scan: An imaging test that uses X-rays to make detailed pictures inside the body.
  • AUC: Area under the curve; a way to measure the total response over time during a test.
  • Photoplethysmography (PPG): A test that uses light to measure changes in blood flow.
  • Thermography: A method that uses heat patterns to look at blood flow in the skin.

References