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Antihypertensive

Mecamylamine Oral Tablet for Spinal Cord Injury

Phase 4
Waitlist Available
Led By EDWARD C NIESHOFF, MD
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes (following initiation of sensory stimulation)
Awards & highlights

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.

Eligible Conditions
  • Spinal Cord Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes (following initiation of sensory stimulation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes (following initiation of sensory stimulation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in heart rate
change in systolic blood pressure
Secondary outcome measures
signs and symptoms of autonomic dysreflexia

Side effects data

From 2014 Phase 3 trial • 21 Patients • NCT00563797
9%
Worsening of Depression
9%
Vomiting/Diarrhea
9%
Relapse to Drinking
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mecamylamine
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mecamylamine Oral TabletExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

Wayne State UniversityLead Sponsor
312 Previous Clinical Trials
109,046 Total Patients Enrolled
EDWARD C NIESHOFF, MDPrincipal InvestigatorWayne State University
~1 spots leftby Sep 2025
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