Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

Phase 4 Completed 453 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the time to treatment intervention in patients with Parkinson's Disease (PD), Multiple System Atrophy (MSA), Pure Autonomic Failure (PAF), Non-Diabetic Autonomic Neuropathy (NDAN) or Dopamine Beta Hydroxylase (DBH) Deficiency who have been previously stabilized with droxidopa therapy for symptoms of neurogenic orthostatic hypotension (NOH) (dizziness, light-headedness, or feelings that they are about to black out)

Timeline

Start: 2016-02-11
Primary completion: 2022-07-21
Completion: 2022-09-09

Publications

Hauser RA, Favit A, Hewitt LA, Lindsten A, Gorny S, Kymes S, Isaacson SH. Durability of the Clinical Benefit of Droxidopa for Neurogenic Orthostatic Hypotension During 12 Weeks of Open-Label Treatment. Neurol Ther. 2022 Mar;11(1):459-469. doi: 10.1007/s40120-021-00317-5. Epub 2022 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Droxidopa	Small molecule	100 mg	Oral
Subject	Droxidopa	Small molecule	200 mg	Oral
Subject	Droxidopa	Small molecule	300 mg	Oral
Subject	Droxidopa	Small molecule	400 mg	Oral
Subject	Droxidopa	Small molecule	500 mg	Oral
Subject	Droxidopa	Small molecule	600 mg	Oral

Sustained Effect of Droxidopa in Symptomatic Neurogenic Orthostatic Hypotension

Summary

Timeline

Publications

Drugs

Indications