NCT01354158

Brief Summary

The investigators seek to determine the efficacy, duration of action and safety of escalating dose of droxidopa on systemic blood pressure, cerebral blood flow and vasoactive hormones and catecholamines during upright seated posture. Primary Question: 1\. What is the lowest dose of droxidopa that increases seated SBP to 115±5 mmHg in men and 105±5 mmHg in women?

  • When does the defined increase in SBP occur after oral ingestion of droxidopa?
  • How long does this dose of droxidopa sustain SBP at these levels?
  • What are the vital signs and the subjective symptomology following droxidopa administration? Secondary Question: 1\. What is the MFV response to droxidopa administration in hypotensive individuals with SCI?
  • Does an increase in SBP correspond to an increase in MCA MFV? Tertiary Question: 1\. What is the vasoactive hormone and catecholamine response to droxidopa administration in hypotensive individuals with SCI?
  • Does droxidopa administration result in a change in APR, Aldo or NE in hypotensive individuals with SCI?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

July 30, 2013

Status Verified

May 1, 2011

Enrollment Period

2 years

First QC Date

May 12, 2011

Last Update Submit

July 29, 2013

Conditions

Spinal Cord InjuryHypotension

Outcome Measures

Primary Outcomes (1)

  • The lowest dose of droxidopa that increases seated SBP to 115±5 mmHg in men and 105±5 mmHg in women

    4 day titration of Droxidopa (placebo day 1, 100mg day 2, 200mg day 3, 400mg day). Blood pressure will be collected at the arm and finger (photoplethysmography) in 15 minute intervals during the duration of the protocol (approximately six hours). The subject will also wear a 24 hour portable arm blood pressure cuff, to assess the effect of Droxidopa on blood pressure 24 hrs post intervention.

    4 days

Secondary Outcomes (2)

  • The MFV response to droxidopa administration in hypotensive individuals with SCI

    4 days

  • To assess the vasoactive hormone and catecholamine response to droxidopa administration in hypotensive individuals with SCI

    4 days

Study Arms (1)

Droxidopa

EXPERIMENTAL

The dose-titration response to ascending doses of Droxidopa (placebo, 100mg, 200mg, 400mg) will be measured four separate days.

Drug: Droxidopa

Interventions

DroxidopaDRUG

Dose titration of placebo, 100mg, 200mg, 400mg of Droxidopa will be given to assess the effects of Droxidopa on blood pressure and cerebral blood flow.

Also known as: L-DOPs
Droxidopa

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between the ages of 18 and 65,
  • diagnosed with hypotension as defined above,
  • able to provide informed consent

You may not qualify if:

  • Known or suspected sensitivity to study medication or any of its ingredients,
  • current smoker,
  • known coronary heart and/or artery disease,
  • hypertension,
  • diabetes mellitus or insipidus,
  • thyroid disease,
  • closed angle glaucoma,
  • acute illness,
  • major surgery in the last 30 days,
  • renal diseases,
  • pregnancy,
  • recent history (within the past year) of cocaine use,
  • tricyclic antidepressants, monoamine oxidase inhibitors, and catechol-O-methyltransferase inhibitors,
  • currently taking vasoconstricting medicines, such as Midodrine, ephedrine, dihydroergotamine, and the triptan class of migraine drugs,
  • Use of a halogen based anesthetic such as Halothane in the past 12 hours
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord InjuriesHypotension

Interventions

Droxidopa

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

NorepinephrineCatecholaminesAminesOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jill M Wecht, EdD

    James J. Peters VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 16, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

July 30, 2013

Record last verified: 2011-05

Locations

US(1)