NCT03914677

Brief Summary

This is a preliminary study of the antihypertensive drug mecamylamine, used in the specific circumstance of hypertension caused by autonomic dysreflexia (AD), a condition that affects people with spinal cord injury (SCI). Initially, mild sensory stimulation of subjects' legs is used to intentionally provoke AD, as reflected by blood pressure elevation during such stimulation. In subsequent testing sessions, mecamylamine is given prior to sensory stimulation, to show the effect of the drug on preventing these AD-related blood pressure elevations.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 13, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

9 months

First QC Date

April 11, 2019

Last Update Submit

October 2, 2019

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuriesautonomic dysreflexiamecamylamine

Outcome Measures

Primary Outcomes (2)

  • change in systolic blood pressure

    difference in systolic blood pressure during leg cuff inflation vs during unstimulated baseline

    10 minutes (following initiation of sensory stimulation)

  • change in heart rate

    difference in heart rate during leg cuff inflation vs during unstimulated baseline

    10 minutes (following initiation of sensory stimulation)

Secondary Outcomes (1)

  • signs and symptoms of autonomic dysreflexia

    10 minutes (following initiation of sensory stimulation)

Study Arms (1)

Mecamylamine Oral Tablet

EXPERIMENTAL

Initial dose - mecamylamine 2.5 mg tablet po 3 hours prior to provocative testing; subsequent dose escalations as needed, to 5 mg and then 7.5 mg, using the same testing methodology.

Drug: Mecamylamine Oral Tablet

Interventions

Mecamylamine Oral TabletDRUG

nicotinic antagonist (ganglionic blocker)

Also known as: Vecamyl
Mecamylamine Oral Tablet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic (\>1 year) SCI at T6 or above, American Spinal Injury Association grade A, B, or C
  • negative serum pregnancy test for females

You may not qualify if:

  • history of arrhythmia, cardiovascular disease, cerebral aneurysm
  • contraindications to use of mecamylamine or midodrine (pregnancy, nursing, glaucoma, kidney disease, pyloric stenosis, arteriosclerosis, or concurrent use of a sulfonamide antibiotic)
  • dependence on reflex voiding for bladder management (mecamylamine may cause urinary retention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

Related Publications (4)

  • Braddom RL, Johnson EW. Mecamylamine in control of hyperreflexia. Arch Phys Med Rehabil. 1969 Aug;50(8):448-53 passim. No abstract available.

    PMID: 5806088BACKGROUND

  • Braddom RL, Rocco JF. Autonomic dysreflexia. A survey of current treatment. Am J Phys Med Rehabil. 1991 Oct;70(5):234-41.

    PMID: 1910647BACKGROUND

  • Eldahan KC, Rabchevsky AG. Autonomic dysreflexia after spinal cord injury: Systemic pathophysiology and methods of management. Auton Neurosci. 2018 Jan;209:59-70. doi: 10.1016/j.autneu.2017.05.002. Epub 2017 May 8.

    PMID: 28506502BACKGROUND

  • Groothuis JT, Rongen GA, Deinum J, Pickkers P, Danser AH, Geurts AC, Smits P, Hopman MT. Sympathetic nonadrenergic transmission contributes to autonomic dysreflexia in spinal cord-injured individuals. Hypertension. 2010 Mar;55(3):636-43. doi: 10.1161/HYPERTENSIONAHA.109.147330. Epub 2010 Jan 25.

    PMID: 20100992BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesAutonomic Dysreflexia

Interventions

Mecamylamine

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesAutonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

NorbornanesBridged Bicyclo CompoundsBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • EDWARD C NIESHOFF, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Ristova-Trendov, MD

CONTACT

313/745-0590dristova@med.wayne.edu

EDWARD C NIESHOFF, MD

CONTACT

2485147659ecnieshoff@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: dose-escalation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

June 13, 2019

Primary Completion

March 17, 2020

Study Completion

December 31, 2020

Last Updated

October 7, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

De-identified participant data will be made available for all primary and secondary outcomes.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within 6 months following completion of the study through 5 years after completion.
Access Criteria
Data access requests will be reviewed by the Research Director of the sponsoring Wayne State University Department of Physical Medicine and Rehabilitation. Data will be made available to researchers who provide a methodologically sound proposal.

Locations

US(1)