Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH) (Droxi-304) (NOH304)
|ClinicalTrials.gov Identifier: NCT01132326|
Recruitment Status : Completed
First Posted : May 28, 2010
Results First Posted : April 21, 2014
Last Update Posted : March 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Autonomic Failure Dopamine Beta Hydroxylase Deficiency Non-Diabetic Neuropathy Neurogenic Orthostatic Hypotension||Drug: Droxidopa||Phase 3|
This is a Phase III, multi-center, open-label study designed to evaluate the long-term safety of droxidopa in subjects with neurogenic orthostatic hypotension (NOH) associated with Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Autonomic Neuropathy.
Patients will be initially treated with droxidopa at their individualized dose identified during the titration phase in Protocol 301. Patients will not require adjustment of their dose, unless their physician feels a dose change will benefit their symptoms, or side effects. At any point in the study a patient's physician may elect to titrate the subject to a higher or lower dose if they feel additional benefit can be safely derived or to deal with any unwanted side-effect.
Patients will return to the clinic for study visits at 1, 3, 6, 9 and 12 months (± 1 week allowed for 1 month visit, ± 2 weeks allowed for subsequent study visits). Patients who prematurely withdraw from the study will be asked to attend the study center for a final assessment At the conclusion of the 12 month treatment period, all patients who benefit from treatment with droxidopa will be offered the option to continue to receive open-label droxidopa through a separate access program.
At any time during the study, patients can schedule a visit with their study physician if they experience a worsening of symptoms and wish to have their dose adjusted or to remove themselves from the trial.
Patients who decide to terminate their participation in the study will receive a phone call 1 month after leaving the trial to follow-up on any new or ongoing adverse events (AEs).
It is a recognized best practice that patients with neurogenic orthostatic hypotension are advised not to lay fully supine because of the associated increased risk of supine hypertension inherent with their condition. Patients participating in this study should be advised to sleep in a semi-recumbent position. .
Patients will attend the study center as out-patients. Patients will be identified using the unique identification number assigned during Protocol 301.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open-label Study to Assess the Long-term Safety of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy and Symptomatic Neurogenic Orthostatic Hypotension|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
- Patients With Treatment-emergent Adverse Events [ Time Frame: up to 2 years ]Number of patients reporting any treatment emergent adverse events (SAE and or AEs) during the study
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132326
|Principal Investigator:||Horacio Kaufmann, MD||New York University School of Medicine|