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Official Study Title: A Multi-Center, Double-Blind,  Double-blindClinical study design in which neither investigators nor participants know who is receiving the investigational drug and who is receiving a placebo. Randomized, Placebo-Controlled, Parallel-Group Withdrawal-Design Study to Assess the Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Effect of Droxidopa in Subjects With Primary Autonomic Failure, Dopamine  DopamineA "chemical messenger" that regulates movement by assisting in the effective communication (transmission) of electrochemical signals in the brain from one nerve cell (neuron) to another. As dopamine producing cells degenerate with advancing PD, they no longer produce enough to regulate neurons elsewhere in the brain, resulting in a loss of control of movements, leading to symptoms such as slowed movements, tremor, and rigidity. Beta Hydroxylase Deficiency or Non-Diabetic Neuropathy...
Sponsor: Chelsea Therapeutics
Clinicaltrials.gov ID: NCT00633880
Study ID: Droxidopa 302

Summary

Blood pressure normally decreases in healthy individuals upon standing. The mechanisms that regulate blood pressure upon standing are dysfunctional in people with orthostatic hypotension (OH), a condition that may lead to inadequate cerebral perfusion (or blood flow to the brain) with accompanying symptoms of syncope (brief loss of consciousness), dizziness or lightheadedness, unsteadiness and blurred or impaired vision, among other symptoms. The autonomic nervous system  Autonomic Nervous SystemControls automatic functions, such as heartbeat, digestion, salivation, and blood pressure. has a central role in the regulation of blood pressure. Primary Autonomic Failure is manifested in a variety of syndromes, and orthostatic hypotension is a typical symptom of this. Primary Autonomic Failure may be the primary diagnosis, and classifications include pure autonomic failure (PAF), also called idiopathic  IdiopathicOf, relating to, or designating a disease having no known cause. orthostatic hypotension (Bradbury-Eggleston syndrome) autonomic failure with multiple system atrophy (Shy-Drager syndrome) and also Parkinson's disease.  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. Regardless of the primary condition, autonomic dysfunction underlies orthostatic hypotension. Orthostatic hypotension may be a severely disabling condition which can seriously interfere with the quality of life those afflicted by it. Currently available therapeutic options provide some symptomatic relief, but are relatively ineffective and are often accompanied by severe side effects  Side Effects Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include such symptoms as headache, nausea and upset stomach. In some cases, side-effects may cause more severe medical problems. that limit their usefulness. Support garments (tight-fitting leotard) may prove useful in some people, but is difficult to don without family or nursing assistance, especially for older people. There are some pharmacological medications that are used to treat orthostatic hypotension, although only midodrine is specifically approved for this purpose. The limitations of these currently available therapeutic options, and the incapacitating nature and often progressive downhill course of the disease, point to the need for an improved therapeutic alternative. This study will measure the efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. of droxidopa on symptoms of neurogenic orthostatic hypotension in participants who will be randomized (placed in groups by randomization,  RandomizationA method based on chance by which study participants are assigned to a treatment group (arm). Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. like the flip of a coin) to continued droxidopa treatment versus placebo,  PlaceboAn inactive substance or procedure (often a pill, liquid, or powder) that has no biological effect. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants will be assigned to a control group and will receive a placebo instead of an active drug or treatment. following 14 days of treatment.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Movement Symptoms

Postural difficulties

Time Commitment

• Less than six months
• The trial will last a maximum of 7 weeks. There are a minimum of 6 visits to the clinic that will be needed, although a total of 11 visits may be necessary. It is possible that a number of visits may occur on consecutive days.

Eligibility

• Minimum Age: 18
• Gender(s) Accepted: Either

Inclusion Criteria

• Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (related to PD)
• A documented fall in systolic blood pressure, or in diastolic blood pressure, within 3 minutes after standing
• Provide written informed consent  Informed ConsentThe process of providing information to potential study participants to help them decide whether or not to enroll in a specific clinical trial. to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care

Exclusion Criteria

• Taking ephedrine or midodrine (people taking ephedrine or midodrine may enroll after a minimum of 2 days of not taking the medication)
• Taking medication for high blood pressure (anti-hypertensive medication), though the use of short-acting anti-hypertensive medications at bedtime is permitted
• Having a history of more than moderate alcohol consumption
• Women who are pregnant or lactating
• Having a history of glaucoma
• Having pre-existing sustained severe high blood pressure
• Having atrial fibrillation or, in the investigator's opinion, having any other significant cardiac arrhythmia
• Having any other significant systemic, hepatic, cardiac or renal illness
• Having diabetes
• Having a known or suspected malignancy
• Having known gastrointestinal illness or other gastrointestinal disorder that may affect the absorption of study drug
• Having other clinically significant health abnormalities that would exclude one, in the investigator’s opinion

Enrollment

Expected Enrollment: 118 (US)
Date Enrollment Began: Jan 01 2008
Last Updated Date: Jun 04 2008
Trial Post Date: Jun 04 2008
Website: http://clinicaltrials.gov/ct2/show/NCT00633880?term=NCT00633880&rank=1

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