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RESTORE: A clinical study of patients with symptomatic neuRogenic orthostatic hypotEnsion to assess Sustained effecTs Of dRoxidopa thErapy
RESTORE: A Study of Patients with symptomatic neurogenic orthostatic hypotension (NOH)
| Sponsor: | Lundbeck Northera Ltd. |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAR4256 |
| U.S. Govt. ID: | NCT02586623 |
| Contact: | Thomas Brannagan, III, MD: 212-305-0405 / tb2325@cumc.columbia.edu |
Additional Study Information:
You are being asked to participate in this study because you have a condition known as symptomatic neurogenic orthostatic hypotension (NOH) associated with Primary Autonomic Failure Parkinsons Disease (PD), Multiple System Atrophy (MSA) or Pure Autonomic Failure (PAF), or Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) deficiency. However, your ability to participate in the study will depend on the results of the screening procedures described below and other criteria. The purpose of this research study is to evaluate two things: (1) the long-term safety of a study drug called droxidopa (also known by the trade name NORTHERA) in people with symptomatic NOH; and (2) How well droxidopa (NORTHERA) treats the symptoms of NOH for a period longer than 2 weeks. Droxidopa is a drug that is changed in the body to a chemical called norepinephrine. Norepinephrine is a chemical in your body that is used by your nervous system to signal nerves that control blood pressure.
This study is closed
Do You Qualify?
| Do you have a clinical diagnosis of symptomatic orthostatic hypotension associated with Primary Autonomic Failure? | Yes | No |
| Do you have untreated closed angle glaucoma? | Yes | No |
| Do you have any significant uncontrolled cardiac arrhythmia (irregular heartbeat)? | Yes | No |
| Do you have a history of congestive heart failure or stroke in the past two years? | Yes | No |
| Do you have any gastrointestinal condition that may affect the absorption of the study drug? | Yes | No |