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View Clinical Trial (Medical Research Study)
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A Clinical Study for Patients With Neurogenic Orthostatic Hypotension (NOH) Using Droxidopa - NCT00782340-92697 (Clinical Trial 250036)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy250036.aspx
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| City: |
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Irvine |
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State:
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CA |
| Zip Code: |
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92697 |
| Conditions: |
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Symptomatic Neurogenic Orthostatic Hypotension (NOH) - Non-diabetic Neuropathy - Primary Autonomic Failure - Dopamine Beta Hydroxylase Deficiency |
| Purpose: |
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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.
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| Study summary: |
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Systolic blood pressure is transiently and minimally decreased in healthy individuals upon
standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to
maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The
compensatory mechanisms that regulate blood pressure upon standing are dysfunctional in
subjects with orthostatic hypotension (OH), a condition that may lead to inadequate cerebral
perfusion with accompanying symptoms of syncope, dizziness or lightheadedness, unsteadiness
and blurred or impaired vision, among other symptoms.
The autonomic nervous system has a central role in the regulation of blood pressure.
Primary Autonomic Failure is manifested in a variety of syndromes. Orthostatic hypotension
is a usual presenting symptom. Primary Autonomic Failure may be the primary diagnosis, and
classifications include pure autonomic failure (PAF), also called idiopathic orthostatic
hypotension (Bradbury-Eggleston syndrome) autonomic failure with multiple system atrophy
(Shy-Drager syndrome) and also Parkinson's disease. 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 of afflicted subjects. Currently available therapeutic options
provide some symptomatic relief in a subset of subjects, but are relatively ineffective and
are often accompanied by severe side effects that limit their usefulness. Support garments
(tight-fitting leotard) may prove useful in some subjects, but is difficult to don without
family or nursing assistance, especially for older subjects. Midodrine, fludrocortisone,
methylphenidate, ephedrine, indomethacin and dihydroergotamine are among some of the
pharmacological interventions that have been used to treat orthostatic hypotension, although
only midodrine is specifically approved for this indication. The limitations of these
currently available therapeutic options, and the incapacitating nature and often progressive
downhill course of disease, point to the need for an improved therapeutic alternative.
The current withdrawal design study will measure the efficacy of droxidopa on symptoms of
neurogenic orthostatic hypotension in patients randomized to continued droxidopa treatment
versus placebo, following 14 days of double-blind treatment.
droxidopa
droxidopa [also, known as L-threo-3,4-dihydroxyphenylserine, L-threo-DOPS, or L-DOPS] is the
International non-proprietary name (INN) for a synthetic amino acid precursor of
norepinephrine (NE), which was originally developed by Sumitomo Pharmaceuticals Co.,
Limited, Japan. It has been approved for use in Japan since 1989. Droxidopa has been shown
to improve symptoms of orthostatic hypotension that result from a variety of conditions
including Shy Drager syndrome (Multiple System Atrophy), Pure Autonomic Failure, and
Parkinson's disease. There are four stereoisomers of DOPS; however, only the
L-threo-enantiomer (droxidopa) is biologically active.
The exact mechanism of action of droxidopa in the treatment of symptomatic NOH has not been
precisely defined; however, its NE replenishing properties with concomitant recovery of
decreased noradrenergic activity are considered to be of major importance.
Droxidopa has been marketed in Japan since 1989. Data from clinical studies and
post-marketing surveillance programs conducted in Japan show that the most commonly reported
adverse drug reactions with droxidopa are increased blood pressure, nausea, and headache.
In clinical studies, the prevalence and severity of droxidopa adverse effects appear to be
similar to those reported by the placebo control arm. |
| Criteria: |
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Inclusion Criteria:
To be eligible for inclusion, each patient must fulfill the following criteria:
- Male or female and aged 18 years or over
- Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic
Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency or Non-Diabetic
Autonomic Neuropathies
- A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic
blood pressure of at least 10 mmHg, within 3 minutes after standing;
- Provide written informed consent 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:
- Currently taking ephedrine or midodrine
- Patients taking ephedrine or midodrine must stop taking these drugs at least 2 days
prior to their baseline visit (Visit 2).
- The use of short-acting anti-hypertensive medications at bedtime is permitted.
- Currently taking tri-cyclic antidepressant medication or other norepinephrine
re-uptake inhibitors;
- Have changed dose, frequency and or type of prescribed medication, within two weeks
of study start (excluding ephedrine and midodrine)
- History of more than moderate alcohol consumption
- History of known or suspected drug or substance abuse
- Women of childbearing potential who are not using a medically accepted contraception
- For WOCP a serum beta HCG pregnancy test must be conducted at screening, and a urine
pregnancy test must be conducted at baseline and study termination; the results must
be negative at screening and at baseline for the patient to receive study medication.
- Sexually active males whose partner is a WOCP and who do not agree to use condoms for
the duration of the study and for 30 days after the last dose;
- Women who are pregnant or breast feeding
- Known or suspected hypersensitivity to the study medication or any of its ingredients
- Pre-existing sustained severe hypertension (BP 180/110 mmHg in the sitting position)
- Have atrial fibrillation or, in the investigator's opinion, have any other
significant cardiac arrhythmia
- Any other significant systemic, hepatic, cardiac or renal illness
- Diabetes mellitus or insipidus
- Have a history of closed angle glaucoma
- Have a known or suspected malignancy
- Have a serum creatinine level > 130 mmol/L
- Patients with known gastrointestinal illness or other gastrointestinal disorder that
may, in the investigator's opinion, affect the absorption of study drug
- In the investigator's opinion, have clinically significant abnormalities on clinical
examination or laboratory testing
- In the investigator's opinion, are unable to adequately co-operate because of
individual or family situation
- In the investigator's opinion, are suffering from a mental disorder that interferes
with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major
depression, dementia
- Are not able or willing to comply with the study requirements for the duration of the
study
- Have participated in another clinical trial with an investigational agent (including
named patient or compassionate use protocol) within 4 weeks before the start of the
study
- Previous enrolment in the study. |
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| Study is available at: |
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University of California, Irvine
Irvine, CA 92697
United States
Primary Contact:
Shari Niswonger
Email: shari.niswonger@uci.edu
Phone: 949-824-8116
Secondary Contact:
Michelle Anthony
Email: michelle.anthony@chiltern.com
Phone: 5122250240 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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