Droxidopa / Pyridostigmine in Orthostatic Hypotension

Orthostatic Hypotension Clinical Trial

Official title:

Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01370512
• Other study ID #: 10-008810
• Secondary ID: P01NS044233
• Status: Suspended
• Phase: Phase 2
• Start date: November 2011
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. The presence of OH (fall in systolic BP >=30 mm Hg) is required for this study.

2. Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.

Exclusion Criteria:

1. Pregnant or lactating females.

2. Chronic illnesses or the presence of other conditions that potentially involve the CNS or affect autonomic testing. These include congestive heart failure, recent (<6 months) myocardial infarct, severe anemia, diabetes mellitus, alcoholism, malignant neoplasms, amyloidosis, hypothyroidism, sympathectomy, cerebrovascular accidents, and neurotoxins or neuroactive drug exposure.

3. Orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living.

4. Any known concurrent infection or severe liver or kidney disease.

5. Medications that could affect autonomic function are suspended prior to autonomic testing. Therapy with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations. Fludrocortisone doses up to 0.2 mg per day will be permitted. Stable doses of antidepressants (tricyclics, SSRIs, SNRIs) will also be permitted. The 48h medication withdrawal is reviewed on a case by case basis - if felt unsafe by the investigators, the withdrawal period may be shortened. This will be documented in the study documents.

6. Occasional use of a neuroleptic as an anti-emetic in the past is allowed, but none can have been used within 3 weeks prior to this study.

7. Use of methylphenidate, cinnarizine, reserpine, amphetamine, atypical antipsychotics such as risperidone, olanzapine, and quetiapine or a MAO-A inhibitor within 3 weeks prior to this study.

8. Dementia (DSM-IV criteria - Amer. Psych. Assoc., 1994). The score on the Mini-Mental State Examination must be >24.

9. History of stroke (diagnosed on clinical grounds as an acute deterioration of neurological function typical of a stroke; confirmatory CT or MRI evidence of stroke will be useful but not necessary).

10. History of electroconvulsive therapy.

11. History of brain surgery for Parkinson's disease.

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Drug:
• Droxidopa
100 mg tablets by mouth three times a day
• Pyridostigmine
60 mg tablets by mouth three times a day

Other:
• Placebo
Looks exactly like the study drug but contains no active ingredients

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in orthostatic diastolic blood pressure	diastolic blood pressure measured upon standing reported in mm/Hg	1 hour after medication administration, 2 hours after medication administration
Secondary	Change in orthostatic systolic blood pressure	systolic blood pressure measured upon standing reported in mm/Hg	1 hour after medication administration, 2 hours after medication administration
Secondary	Change in absolute supine diastolic blood pressure	diastolic blood pressure measured while lying flat reported in mm/Hg	1 hour after medication administration, 2 hours after medication administration
Secondary	Change in absolute supine systolic blood pressure	systolic blood pressure measured while lying flat reported in mm/Hg	1 hour after medication administration, 2 hours after medication administration
Secondary	Change in supine norepinephrine levels	measure of serum norepinephrine levels while lying flat reported in pg/mL	1 hour after medication administration, 2 hours after medication administration
Secondary	Change in orthostatic symptoms	measured during tilt study, the patient will be asked to score orthostatic symptoms on a symptom scale ranging from "0" = no symptoms to "10" = near syncope	1 hour after medication administration, 2 hours after medication administration