NCT02919917

Treatment of Post-SCI Hypotension

Completed Phase 2, PHASE3 Results posted Last updated 21 February 2025

What this trial tests

Phase 2, PHASE3 trial testing Midodrine Hydrochloride in Spinal Cord Injury in 66 participants. Completed in 1 September 2021.

Timeline

1 June 2017

Primary endpoint
1 September 2021

1 September 2021

Quick facts

Lead sponsor	James J. Peters Veterans Affairs Medical Center
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	66
Start date	1 June 2017
Primary completion	1 September 2021
Estimated completion	1 September 2021
Sites	2 locations across United States

Drugs / interventions tested

• Midodrine Hydrochloride — full drug profile →
• Midodrine Hydrochloride — full drug profile →

Conditions studied

• Spinal Cord Injury — all drugs for Spinal Cord Injury →
• Autonomic Dysreflexia — all drugs for Autonomic Dysreflexia →
• Orthostatic Hypotension — all drugs for Orthostatic Hypotension →
• Baroreceptor Integrity — all drugs for Baroreceptor Integrity →

Sponsor

James J. Peters Veterans Affairs Medical Center

Who can join

Adults 18 to 89, any sex, with Spinal Cord Injury or Autonomic Dysreflexia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Affected Therapy Sessions Primary · Inpatient hospitalization (up to 4 months)

Responses to the questions "was the therapy session affected by low BP or concern for low BP development?" between the usual care and BP threshold treatment groups. The percent of sessions with a "yes" response are reported.

Group	Value	95% CI
Usual Care Group	16.4
BP Threshold Treatment Group	10.9

Systolic Blood Pressure Primary · Inpatient hospitalization (up to 4 months)

Systolic hypertension (\>/= 140 mmHg)

Group	Value	95% CI
Usual Care Group	4.8
BP Threshold Treatment Group	5.3

Systolic Blood Pressure Secondary · Inpatient Hospitalizations (up to 4 months)

Systolic hypotension (males: \< 110 mmHg; females: \< 100 mmHg)

Group	Value	95% CI
Usual Care Group	39.7
BP Threshold Treatment Group	43.0

Missed Therapy Sessions Secondary · Inpatient Hospitalizations (up to 4 months)

Percentages of missed therapy sessions, due to low BP or concern for low BP development, in the usual care and BP treatment groups

Group	Value	95% CI
Usual Care Group	58.60
BP Threshold Treatment Group	65.8

Sponsor's own description

While treatment strategies for OH have been identified for use in persons with acute SCI, the field of SCI medicine lacks a gold standard for treatment thresholds and well-defined outcome parameters. Comprehensively documenting the impact of orthostatic hypotension (OH), regardless of symptoms, during acute rehabilitation and identifying the effects of two different treatment approaches on therapy participation and adherence to an intended rehabilitation plan could have a significant impact on clinical practice in the acute rehabilitation setting following SCI.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of Cardiovascular Autonomic Function during Inpatient Rehabilitation following Traumatic Spinal Cord Injury.
   Wecht JM, Weir JP, Noonavath M, Vaccaro DH, et al · · 2022 · cited 2× · PMID 35579968 · DOI 10.1089/neu.2021.0379
2. Treatment of Orthostatic Hypotension During Acute Inpatient Rehabilitation After Spinal Cord Injury: Usual Care vs. Anti-hypotensive Therapy.
   Wecht JM, Weir JP, Huang V, Escalon MX, et al · · 2024 · PMID 38712567 · DOI 10.1093/ajh/hpae057