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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00223691 |
Purpose
The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Pure Autonomic Failure Orthostatic Hypotension |
Drug: Atomoxetine Drug: Acarbose Drug: Pyridostigmine Bromide Drug: Yohimbine Drug: Midodrine HCl Drug: placebo Drug: Modafinil Drug: Octreotide Other: water intake Drug: Diphenhydramine Hydrochloride Drug: Ranitidine HCL Drug: Tranylcypromine Drug: Ergotamine/ Caffeine Drug: Celecoxib Drug: Pseudoephedrine Drug: Methylphenidate Drug: Indomethacin Drug: Ibuprofen Drug: Oxymetazoline 0.05% nasal solution Dietary Supplement: Bovril Drug: Acetazolamide Drug: Rivastigmine tartrate Drug: Carbidopa/levodopa Device: abdominal binder Device: abdominal binder (sham) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation and Treatment of Autonomic Failure. |
| Estimated Enrollment: | 500 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1: active intervention
pressor agents, acarbose, acetazolamide, carbidopa/levodopa, abdominal binder or bovril
|
Drug: Atomoxetine
10-50 mg, PO. Single dose. Alone or in combination with Yohimbine or Mestinon.
Other Name: Strattera
Drug: Acarbose
25-100 mg, PO. Single dose.
Other Name: Precose
Drug: Pyridostigmine Bromide
30 mg-180 mg PO. Single dose. Alone or in combination with Yohimbine or atomoxetine.
Other Name: Mestinon
Drug: Yohimbine
2.7, 5.4 or 10.8 mg PO. Single dose. Alone or in combination with Atomoxetine or Pyridostigmine.
Other Name: Yocon
Drug: Midodrine HCl
2.5, 5.0, 7.5, 10 mg PO. Single dose
Other Name: ProAmatine
Drug: Modafinil
50-400 mg PO. Single dose
Other Name: Provigil
Drug: Octreotide
5-50 µg, S.C. Single dose.
Other Name: Sandostatin
Other: water intake
Tap water 2 onz., 8 oz., 16 oz. PO, alone or in combination with any of the above medications. Single dose.
Drug: Diphenhydramine Hydrochloride
12.5 mg-100 mg PO. Single dose. Alone or in combination with Ranitidine
Other Name: Benadryl
Drug: Ranitidine HCL
150-300 mg PO. Single dose. Alone or in combination with Diphenhydramine.
Other Name: zantac
Drug: Tranylcypromine
5 - 40 mg PO. Single dose
Other Name: Parnate
Drug: Ergotamine/ Caffeine
Ergotamine: 1.0 mg PO. Single dose. Caffeine 100 mg PO.Single dose
Other Name: Cafergot
Drug: Celecoxib
50-200 mg PO. Single dose
Other Name: Celebrex
Drug: Pseudoephedrine
15, 30 or 60 mg, PO. Single dose.
Other Name: Sudafed
Drug: Methylphenidate
5 or 10 mg PO. Single dose.
Other Name: Ritalin
Drug: Indomethacin
25, 50 or 75 mg, PO. Singe dose.
Other Name: Indocin
Drug: Ibuprofen
300, 600 or 900 mg, PO. Single dose.
Other Name: Advil, Motrin
Drug: Oxymetazoline 0.05% nasal solution
1-2 sprays/ nostril. Single dose.
Other Name: Afrin
Dietary Supplement: Bovril
6-10 g, PO. Single dose.
Drug: Acetazolamide
125-1000 mg PO. Single dose. Alone or in combination with yohimbine or midodrine
Other Name: Diamox
Drug: Rivastigmine tartrate
1.5-6 mg PO. Single dose.
Other Name: Exelon
Drug: Carbidopa/levodopa
10mg/100mg or 25mg/100mg. 1-2 tab PO. Single dose. Alone or in combination with carbidopa (Lodosyn) 25-175 mg
Other Name: Sinemet, Lodosyn
Device: abdominal binder
External abdominal compression (20-40 mm Hg) with an abdominal binder applied for 70 min before and after a pressor agent (e.g. midodrine, yohimbine).
Other Name: external abdominal compression
|
|
Placebo Comparator: 2: Placebo or sham device
placebo pill or abdominal binder (sham)
|
Drug: placebo
PO.Single dose.
Device: abdominal binder (sham)
External abdominal compression (5 mm Hg) with an abdominal binder applied for 70 min before and after a pressor agent (e.g. midodrine, yohimbine).
Other Name: external abdominal compression (sham)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bonnie Black, RN | adcresearch@vanderbilt.edu |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Bonnie Black, RN adcresearch@vanderbilt.edu | |
| Principal Investigator: Biaggioni Italo, MD | |
| Sub-Investigator: Cyndya Shibao, MD | |
| Sub-Investigator: David Robertson, MD | |
| Sub-Investigator: Andre Diedrich, MD | |
| Sub-Investigator: Alfredo Gamboa, MD | |
| Sub-Investigator: Satish Raj, MD | |
| Sub-Investigator: Kyoko Sato, MD | |
| Sub-Investigator: Luis E Okamoto, MD | |
| Sub-Investigator: Hossam Mustafa, MD | |
| Sub-Investigator: Amy C Arnold, PhD | |
| Sub-Investigator: Cindy A Dorminy, MEd, LPN | |
| Sub-Investigator: Emily M Garland, PhD | |
| Sub-Investigator: Melissa R Kaufman, MD, PhD | |
| Principal Investigator: | Italo Biaggioni, MD | Vanderbilt University |
More Information
| Responsible Party: | Italo Biaggioni, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00223691 History of Changes |
| Other Study ID Numbers: | 000814, HL46681 |
| Study First Received: | September 14, 2005 |
| Last Updated: | March 15, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
orthostatic hypotension autonomic failure |
|
Hypotension Hypotension, Orthostatic Pure Autonomic Failure Vascular Diseases Cardiovascular Diseases Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Acetazolamide Bromides Diphenhydramine Caffeine Carbidopa Ephedrine |
Ergotamine Ibuprofen Levodopa Methylphenidate Tranylcypromine Modafinil Carbidopa, levodopa drug combination Rivastigmine Indomethacin Pyridostigmine Bromide Acarbose Celecoxib Promethazine Yohimbine Pseudoephedrine |
