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Pilot Study of Mecamylamine for Autonomic Dysreflexia Prophylaxis

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ClinicalTrials.gov Identifier: NCT03914677
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
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. 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 Detailed Description

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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
Estimated Study Start Date : April 18, 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. symptoms [ Time Frame: 10 minutes (following initiation of sensory stimulation) ]
    piloerection, diaphoresis, headache



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

Inclusion Criteria: Chronic (>1 year) severe cervical SCI (no voluntary movement in the trunk or legs), negative serum pregnancy test for females, age 18-75.

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Exclusion Criteria: Risk factors for heart problems, stroke, or other harm from participation - e.g., known irregular heartbeat, history of heart disease; risk factors for occult cardiovascular disease - as suggested by history of smoking, obesity, diabetes, or high cholesterol; or contraindications to use of mecamylamine or midodrine (conditions such as pregnancy, nursing, glaucoma, kidney disease, pyloric stenosis, arteriosclerosis, or concurrent use of a sulfonamide or antibiotic), or dependence on reflex voiding for bladder management (mecamylamine may cause urinary retention).

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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 ClinicalTrials.gov identifier (NCT number): NCT03914677


Contacts
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Contact: Daniela Ristova-Trendov, MD 313/745-0590 dristova@med.wayne.edu
Contact: EDWARD C NIESHOFF, MD 2485147659 ecnieshoff@gmail.com

Locations
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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Daniela Ristova-Trendov, MD    313-745-0590    dristova@med.wayne.edu   
Contact: EDWARD C NIESHOFF, MD    2485147659    ecnieshoff@gmail.com   
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: EDWARD C NIESHOFF, MD Wayne State University

Publications:
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Responsible Party: Edward Nieshoff, MD, Principal Investigator, Wayne State University
ClinicalTrials.gov Identifier: NCT03914677     History of Changes
Other Study ID Numbers: 080518MP2F
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 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.

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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, mecamylamine
Additional relevant MeSH terms:
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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
Mecamylamine
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