NCT03350659

Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH

Efficacy and Safety of Midodrine and Atomoxetine Treatment in Patients With Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, open-label clinical trial. We will enroll patients with symptomatic neurogenic OH and randomize them to 1 of 2 treatments: (1) midodrine only, (2) atomoxetine only. We will follow up patients at 1 and 3 months after treatment. If the patients meet BP criteria for OH at 1 month, they will receive combination treatment with both midodrine and atomoxetin. The primary outcome measure is amelioration of questionnaire score evaluating OH-associated symptoms at 3 months. Secondary end-points were improvement in orthostatic blood pressure (BP) drop at 1 and 3 months.

Detailed description

Visit 1. 1. Enroll, baseline evaluation of the patients 2. Questionnaire * Evaluate orthostatic hypotension symptom: Orthostatic Hypotension Questionnaire (OHQ) * Quality of life: Korean version of Short-form 36 * Depressive symptom: Korean version of Beck Depression Inventory(BDI)-2 3. Blood test (6cc): ELISA for alpha 1,2 and beta 1,2 adrenergic receptor antibody and nicotinic acetylcholine receptor antibody. Preserve sample for genetic testing. 4. Randomization: randomize patients to three group in 1:1 ratio (Midodrine 5mg/day single, Atomoxetine 18mg/day single) 5. Treatment education Visit 2. 1 month after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire If the patients meet BP criteria for OH, initiate combination treatment (Midodrine 5mg/day+Atomoxetine 18mg/day) Visit 3. 3 months after treatment Orthostatic BP check/ check drug compliance and side effect/ Questionnaire

Conditions

• Neurogenic Orthostatic Hypotension

Interventions

Type	Name	Description
DRUG	Midodrine	Midodrine single 5mg/day
DRUG	Atomoxetine	Atomoxetine single 18mg/day

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-01-29
• Completion: 2019-03-15
• First posted: 2017-11-22
• Last updated: 2019-04-05

Locations

1 site across 1 country: South Korea