drugset / Trial / NCT00633880
Clinical Study of Droxidopa in Patients With Neurogenic Orthostatic Hypotension (NOH)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
Timeline
- Start
- 2008-01
- Primary completion
- 2009-08
- Completion
- 2009-09
Publications
- Biaggioni I, Arthur Hewitt L, Rowse GJ, Kaufmann H. Integrated analysis of droxidopa trials for neurogenic orthostatic hypotension. BMC Neurol. 2017 May 12;17(1):90. doi: 10.1186/s12883-017-0867-5.
- Francois C, Rowse GJ, Hewitt LA, Vo P, Hauser RA. Analysis of number needed to treat for droxidopa in patients with symptomatic neurogenic orthostatic hypotension. BMC Neurol. 2016 Aug 18;16(1):143. doi: 10.1186/s12883-016-0665-5.
- Biaggioni I, Freeman R, Mathias CJ, Low P, Hewitt LA, Kaufmann H; Droxidopa 302 Investigators. Randomized withdrawal study of patients with symptomatic neurogenic orthostatic hypotension responsive to droxidopa. Hypertension. 2015 Jan;65(1):101-7. doi: 10.1161/HYPERTENSIONAHA.114.04035. Epub 2014 Oct 27.
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 |