Search > Neurogenic Orthostatic Hypotension
12 Participants Needed

A study for Neurogenic Orthostatic Hypotension

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: CuraSen Therapeutics, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called CST-3056, a potential drug for people with neurogenic orthostatic hypotension (nOH). This condition causes dizziness or fainting when standing due to low blood pressure. This trial suits those with nOH linked to Parkinson’s disease or pure autonomic failure who frequently experience dizziness when standing. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before and during the trial. The clinical team will work with you throughout the trial to help manage your medications.

Is there any evidence suggesting that CST-3056 is likely to be safe for humans?

Research has shown that CST-3056 was safe in earlier studies. In a previous study, participants tolerated CST-3056 well, with no major safety issues reported. This treatment is now in a Phase 2 trial, indicating some early evidence of safety, with researchers aiming to confirm these results with a larger group.

Why do researchers think this study treatment might be promising for neurogenic orthostatic hypotension?

CST-3056 is unique because it takes a fresh approach to treating neurogenic orthostatic hypotension (nOH). CST-3056 works by activating specific receptors in blood vessels to stabilize blood pressure and maintain cerebral blood flow. Researchers are excited about CST-3056 because it could provide faster symptom relief and a more optimized dosage period compared to existing options.

Are You a Good Fit for This Trial?

Adults aged 18-85 with neurogenic orthostatic hypotension (nOH) due to Parkinson's disease or pure autonomic failure. Participants should have stable medication doses and medical conditions, not use certain blood pressure medications, and have a BMI between 18 and 35 kg/m2.

Inclusion Criteria

Have you been diagnosed with Parkinson's disease or pure autonomic failure (PAF)?
Do you get dizzy or lightheaded when you stand up?

Exclusion Criteria

Have you been diagnosed with or treated for cancer in the last 5 years?
When you stand up, does your heart race or pound?
Are you a frequent user of drugs of abuse (such as methamphetamine, opiates and cocaine)?
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Patients will be staying in-patient in a clinic for 5 nights. Participants receive single oral doses of CST-3056 or a placebo once daily for five days, with dose optimization based on observations. Over the 5 days of the study they will receive one dose of placebo and 4 doses of CST-3056.

5 days
1 visit (in clinic)

Follow-up

Participants are contacted by phone to review health status and report any adverse events

1 week
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • CST-3056

Trial Overview

The trial is testing CST-3056 against a placebo to see if it improves symptoms of nOH. Participants will be administered either drug or placebo each day of the study. Over the 5 days of the study they will receive one dose of placebo and 4 doses of the medication given once daily.

Who Is Running the Clinical Trial?

CuraSen Therapeutics, Inc.

Lead Sponsor

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