Efficacy and Safety of Midodrine and Atomoxetine for Neurogenic OH

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Neurogenic Orthostatic Hypotension

Treatments: Drug: Midodrine; Drug: Atomoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT03350659

1710-060-893

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >=19 patients who complained of dizziness
• Orthostatic hypotension after 3-minute standing (systolic blood pressure drop >=20 or diastolic blood pressure drop >=10

Exclusion criteria

• Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
• Heart failure or Chronic renal failure
• Severe supine hypertension (Systolic Blood Pressure >180 or Diastolic Blood Pressure>110mmHg)
• Pregnant women, breast-feeding
• Unable to perform questionnaire

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Atomoxetine

Experimental group

Description:

Atomoxetine 18mg once a day.

Treatment:

Drug: Atomoxetine

Midodrine

Active Comparator group

Description:

midodrine 2.5mg twice a day (increase to 5mg three times a day if necessary)

Treatment:

Drug: Midodrine