Carbidopa for the Treatment of Excessive Blood Pressure Variability
NCT ID: NCT02553265
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2015-09-30
2019-05-10
Brief Summary
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Detailed Description
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Aim 1: To evaluate the safety and tolerability of carbidopa in FD patients with particular emphasis on the orthostatic fall in blood pressure.
Aim 2: As proof of concept, examine the hemodynamic effects of carbidopa and determine its effects on norepinephrine production, BP variability and paroxysmal hypertension.
Aim 3: In a dose finding study, compare the effects of low (300 mg/day) and high (600 mg/day) dose carbidopa blockade vs. placebo on BP variability and paroxysmal hypertension.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo
Placebo
A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.
Low-Dose Carbidopa
Carbidopa Low-Dose
300 mg/day
High-Dose Carbidopa
Carbidopa High-Dose
600 mg/day
Interventions
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Carbidopa Low-Dose
300 mg/day
Placebo
A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.
Carbidopa High-Dose
600 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unstable blood pressure, defined as:
* Systolic BP standard deviation \>15 mmHg
* Or coefficient of variation \>15%
* Or documented episodic hypertensive peaks (\>140mmHg)
* Confirmed diagnosis of FD (genetic testing)
* Providing written informed consent (or ascent) to participate in the trial
* Ability to comply with the requirements of the study procedures.
Exclusion Criteria
* Patients taking: metoclopramide, domperidone, risperidone or other dopamine blockers
* Patients taking tricyclic antidepressants
* Patients taking neuroleptic drugs (haloperidol and chlorpromazine)
* Patients with a known hypersensitivity to any component of this drug.
* Patients with atrial fibrillation, angina or significant ECG abnormality
* Patients with significant pulmonary, cardiac, liver, renal (creatinine \>2.0 mg/ml)
* Patients who have a significant abnormality on clinical examination that may, in the investigator's opinion might jeopardize their healthy participating in this trial.
* Women who are pregnant or lactating.
10 Years
60 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Horacio C Kaufmann, MD
Role: PRINCIPAL_INVESTIGATOR
NYU School of Medicine
Lucy J Norcliffe-Kaufmann, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU School of Medicine
Locations
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NYU Langone Medical Center, Dyautonomia Center, Suite 9Q
New York, New York, United States
NYU Medical Center
New York, New York, United States
Countries
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References
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Norcliffe-Kaufmann L, Martinez J, Axelrod F, Kaufmann H. Hyperdopaminergic crises in familial dysautonomia: a randomized trial of carbidopa. Neurology. 2013 Apr 23;80(17):1611-7. doi: 10.1212/WNL.0b013e31828f18f0. Epub 2013 Apr 3.
Norcliffe-Kaufmann LJ, Axelrod FB, Kaufmann H. Cyclic vomiting associated with excessive dopamine in Riley-day syndrome. J Clin Gastroenterol. 2013 Feb;47(2):136-8. doi: 10.1097/MCG.0b013e3182582cbf.
Norcliffe-Kaufmann L, Axelrod FB, Kaufmann H. Developmental abnormalities, blood pressure variability and renal disease in Riley Day syndrome. J Hum Hypertens. 2013 Jan;27(1):51-5. doi: 10.1038/jhh.2011.107. Epub 2011 Dec 1.
Kaufmann H, Malamut R, Norcliffe-Kaufmann L, Rosa K, Freeman R. The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale. Clin Auton Res. 2012 Apr;22(2):79-90. doi: 10.1007/s10286-011-0146-2. Epub 2011 Nov 2.
Norcliffe-Kaufmann L, Axelrod F, Kaufmann H. Afferent baroreflex failure in familial dysautonomia. Neurology. 2010 Nov 23;75(21):1904-11. doi: 10.1212/WNL.0b013e3181feb283.
Palma JA, Norcliffe-Kaufmann L, Fuente-Mora C, Percival L, Mendoza-Santiesteban C, Kaufmann H. Current treatments in familial dysautonomia. Expert Opin Pharmacother. 2014 Dec;15(18):2653-71. doi: 10.1517/14656566.2014.970530. Epub 2014 Oct 17.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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New York University (NYU) Dysautonomia Center Research Site
Familial dysautonomia medical information
Patient Advocacy Group
Other Identifiers
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FD-R-004772
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
13-00065
Identifier Type: -
Identifier Source: org_study_id
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