A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's Disease
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
This is a study to evaluate the effects of an investigational drug, Droxidopa, in
participants with neurogenic orthostatic hypotension (NOH), associated with Parkinson's
disease. Droxidopa is being studied to determine the effects on blood pressure changes upon
standing up (orthostatic challenge). Symptoms and activity measurements, including patient
reported falls, will be evaluated to determine the effectiveness of the study drug.
Symptoms of NOH may include any of the following:
- Dizziness, light-headedness, feeling faint or feeling like you may blackout
- Problems with vision (blurring, seeing spots, tunnel vision, etc.)
- Weakness
- Fatigue
- Trouble concentrating
- Head & neck discomfort (the coat hanger syndrome)
- Difficulty standing for a short time or a long time
- Trouble walking for a short time or a long time
The study duration is a maximum of approximately 14 weeks including up to 2 weeks for
screening, up to 2 weeks for proper dose finding, followed by an 8 week treatment period and
a follow-up visit after 2 weeks. A sufficient number of patients will be screened to allow
approximately 211 randomized patients. An extension study is also available to continue
treatment if determined appropriate by the study doctor. This Study is NCT01132326 sponsored
by Chelsea Therapeutics and is enrolling by invitation only.