COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Mecamylamine for Autonomic Dysreflexia Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03914677
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : October 7, 2019
Information provided by (Responsible Party):
Edward Nieshoff, MD, Wayne State University

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: Mecamylamine Oral Tablet Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Sequential Assignment
Intervention Model Description: dose-escalation
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Study of Mecamylamine for Autonomic Dysreflexia Prophylaxis
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : March 17, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Mecamylamine Oral Tablet
nicotinic antagonist (ganglionic blocker)
Other Name: Vecamyl

Primary Outcome Measures :
  1. change in systolic blood pressure [ Time Frame: 10 minutes (following initiation of sensory stimulation) ]
    difference in systolic blood pressure during leg cuff inflation vs during unstimulated baseline

  2. change in heart rate [ Time Frame: 10 minutes (following initiation of sensory stimulation) ]
    difference in heart rate during leg cuff inflation vs during unstimulated baseline

Secondary Outcome Measures :
  1. signs and symptoms of autonomic dysreflexia [ Time Frame: 10 minutes (following initiation of sensory stimulation) ]
    piloerection, diaphoresis, headache

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03914677

Layout table for location contacts
Contact: Daniela Ristova-Trendov, MD 313/745-0590
Contact: EDWARD C NIESHOFF, MD 2485147659

Layout table for location information
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Daniela Ristova-Trendov, MD    313-745-0590   
Contact: EDWARD C NIESHOFF, MD    2485147659   
Sponsors and Collaborators
Wayne State University
Layout table for investigator information
Principal Investigator: EDWARD C NIESHOFF, MD Wayne State University
Layout table for additonal information
Responsible Party: Edward Nieshoff, MD, Principal Investigator, Wayne State University Identifier: NCT03914677    
Other Study ID Numbers: 080518MP2F
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data will be made available for all primary and secondary outcomes.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edward Nieshoff, MD, Wayne State University:
Spinal Cord Injuries
autonomic dysreflexia
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Autonomic Dysreflexia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Autonomic Nervous System Diseases
Antihypertensive Agents
Ganglionic Blockers
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action