Recruiting

Mecamylamine

Sponsor:

Wayne State University

Code:

NCT03914677

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mecamylamine Oral Tablet

Study Details

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.

Conditions

Spinal Cord Injuries

Study ID

NCT03914677

Start date

Jun 13, 2019

Status verified date

Oct, 2019

Completion date

Dec 31, 2020

Anticipated

Primary completion date

Mar 17, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mecamylamine Oral Tablet

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.

Interventions

Mecamylamine Oral Tablet

nicotinic antagonist (ganglionic blocker)

Primary outcome measure

  • change in systolic blood pressure [ Time Frame: 10 minutes (following initiation of sensory stimulation) ]
  • change in heart rate [ Time Frame: 10 minutes (following initiation of sensory stimulation) ]

Central Contacts and Locations

Central contacts

Daniela Ristova-Trendov, MD

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

EDWARD C NIESHOFF, MD

2485147659ecnieshoff@gmail.com

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Daniela Ristova-Trendov, MD

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

EDWARD C NIESHOFF, MD

2485147659ecnieshoff@gmail.com

More Information

Sponsor

Wayne State University

Last update posted

Oct 7, 2019

Last verified

Oct, 2019

Keywords

  • Spinal Cord Injuries
  • autonomic dysreflexia
  • mecamylamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wayne State University on 2019-10-07.