Orthostatic hypotension (OH) can cause dizziness, lightheadedness, and even angina on standing. It occurs when the autonomic reflexes that control blood pressure are impaired. OH is common and often an early sign of multiple system atrophy.
Norepinephrine is released by the autonomic nervous system and is the main neurotransmitter that prevents blood pressure from falling to low levels when upright. Around 50% of patients with MSA fail to release norepinephrine on standing, causing their blood pressure to fall to very low levels.
The NYU Dysautonomia Center has 2 new clinical trials to test new drugs that are being developed for the treatment of OH in patients with MSA. Both compounds work by enhancing the body’s levels of norepinephrine.
Both studies are also being carried out at the Autonomic Dysfunction Center at Vanderbilt University, which are our long time collaborative partners in rare autonomic disorders.
Together we are testing whether blocking the re-uptake of norepinephrine can help raise blood pressure and improve symptoms of low blood pressure when standing.
These strategies are being thoroughly tested by the Center and its partners to see whether this approach can be helpful for patients with MSA that have orthostatic hypotension. If you have orthostatic hypotension, you can enroll in either or both of these clinical trials in New York City or Nashville, TN . Learn more about the studies below and how to contact the Centers to find out if you are eligible to enroll.
STUDY 1: A Phase 2 Study to Assess the Effect and Safety of TD-9855 in Subjects with Neurogenic Orthostatic Hypotension
NIH Clinical Trials Webpage: https://clinicaltrials.gov/ct2/show/NCT02705755
This study is in collaboration with Theravance Biopharma R&D. We are testing the acute efficacy and safety of a new compound (TD-9855) in improving blood pressure and reducing orthostatic symptoms in patients that have neurogenic orthostatic hypotension (nOH), which includes those with MSA. This study is also open to patients with Pure Autonomic Failure (PAF) and Parkinson’s Disease (PD) with NOH.
STUDY 2: Phase2 Norepinephrine Transporter Blockade, Autonomic Failure”
NIH Clinical Trials Webpage: https://clinicaltrials.gov/ct2/show/NCT02784535
This study is supported by The Food and Drug Administration’s Office of Orphan Product development. , We are testing whether we can re-purpose an available drug (atomoxetine) as a treatment for neurogenic orthostatic hypotension (nOH). This study is also open to patients with MSA, pure autonomic failure (PAF), and Parkinson disease (PD) with OH.
Both studies are being performed at NYU’s Dysautonomia Center and Vanderbilt University’s Autonomic Group.
If you are interested in either study or want more information, please do not hesitate to contact us:
Contact person (s): Clinical Trials Manager (NY) Jose Martinez, email: Jose.Martinez@nyumc.org. Location: NYU Dysautonomia Center; New York University School of Medicine, 530 First Ave. Suite 9Q, New York, NY 10016. Telephone: +1 212 263 7225. Website: http://www.med.nyu.edu/neurology/dysautonomia-center
Clinical Trials Manager (TN), Bonnie Black, email: firstname.lastname@example.org. Location: Autonomic Dysfunction Center, Vanderbilt University Medical Center. Telephone: +1 615-343-6862. Website: https://ww2.mc.vanderbilt.edu/adc/
The NYU Dysautonomia Center is a leading center of research, treatment, and management of autonomic disorders located right in the heart of New York City.