Treatment of Orthostatic Hypotension in SCI

NCT05839652 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 1747301-1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.

Conditions

Hypotension

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo

  3 years

Secondary Outcomes (2)

• Cerebral blood flow velocity

  3 years

• Symptoms of autonomic dysreflexia and orthostatic hypotension

  3 years

Study Arms (2)

Study 1

EXPERIMENTAL

Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension.

Drug: Midodrine Hydrochloride

Study 2

EXPERIMENTAL

Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort.

Drug: Midodrine Hydrochloride

Interventions

Midodrine Hydrochloride DRUG

Determine best drug and dose to increase and stabilize SBP during orthostatic tilt

Also known as: Droxidopa

Study 1; Study 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• traumatic spinal cord injury
• at least 12 months post injury
• injury level of C1-T6
• AIS A, B or C
• non-ambulatory
• non-ventilator

You may not qualify if:

• Active psychiatric disorder
• Stroke or cerebrovascular disease
• Alzheimer's Disease or dementia
• Unmanaged cardiac arrhythmias
• Concurrent systemic, hepatic, or renal disease
• Suspected or diagnosed malignancy
• Neurological disease other than SCI
• Self-reported history of three or more symptomatic episodes of AD per day

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead
• Kessler Foundation: collaborator

Study Sites (2)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

James J Peters VA Medical Center

The Bronx, New York, 10468, United States

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Midodrine; Droxidopa

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Norepinephrine; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Matt G. Maher, MS

CONTACT

9733243588; matt.maher@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)