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| Name | Class |
|---|---|
| Lundbeck LLC | INDUSTRY |
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This is a double blind placebo controlled trial in Parkinson's disease (PD) patients with neurogenic orthostatic hypotension (NOH). Investigators hypothesize that the study drug (droxidopa) may improve cerebral perfusion more robustly than systemic BP, possibly by direct action within the CNS vasculature. This study is designed to determine if droxidopa improves cerebral perfusion measures in PD patients with NOH, in addition to peripheral BP measures and subjective responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention phase | Experimental | Droxidopa unforced titration dose (starting at 100mg by mouth TID) or matching placebo and titrated over 2 weeks up to maximum of 600 TID. Efficacy evaluation of given dose at week 4 |
|
| Open label extension phase | Other | All subjects allowed into a 4 week open label extension. Similar titration will start at 100mg Droxidopa three times a day (TID), but can be titrated up daily using the same dose escalation scale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Droxidopa | Drug | Droxidopa initial dose 100mg TID, titrated in increments of 100mg every 24-48 hours to symptomatic response. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral perfusion | Cerebral perfusion measured by trans-cranial ultrasound of middle cerebral artery "supine and standing" delta. | 8 weeks |
| Brain oxygenation | Brain oxygenation as measured by cerebral pulse oximetry device, delta between supine and standing | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arteriole Blood Pressure | Change in arteriole BP (supine/standing) via tilt table | 8 weeks |
| R-R variability | changes in autonomic influence on heart rate placebo vs drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of depressive symptoms | Beck Depression Inventory | 8 weeks |
| Assessment of sleepiness | Epworth sleepiness scale (ESS) | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Ondo, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D015103 | Droxidopa |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo (sugar pill) |
|
|
| 8 weeks |
| Orthostatic hypotension | Orthostatic hypotension scale | 8 weeks |
| Assessment of Parkinson's disease symptoms | Movement disorder society- Unified parkinson disease rating scale (MDS-UPDRS) | 8 weeks |
| Assessment of gait and falls | Timed Up and Go test | 8 weeks |
| Assessment of cognitive changes | Montreal cognitive assessment (MOCA) | 8 weeks |
| Assessment of fatigue | Fatigue severity scale (FSS) | 8 weeks |
| Participant impression of light-headedness | Subjective assessment of "light-headedness" | 8 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |