midodrine and Autonomic Failure, Progressive

midodrine has been researched along with Autonomic Failure, Progressive in 7 studies

Midodrine: An ethanolamine derivative that is an adrenergic alpha-1 agonist. It is used as a vasoconstrictor agent in the treatment of HYPOTENSION.
midodrine : An aromatic ether that is 1,4-dimethoxybenzene which is substituted at position 2 by a 2-(glycylamino)-1-hydroxyethyl group. A direct-acting sympathomimetic with selective alpha-adrenergic agonist activity, it is used (generally as its hydrochloride salt) as a peripheral vasoconstrictor in the treatment of certain hypotensive states. The main active moiety is its major metabolite, deglymidodrine.

Research

Studies (7)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Gait Analysis - Gait Velocity

"Using a gait mat, participants were instructed to walk self-paced on the mat, turn around, and walk back. Their velocity was measured in cm/sec.~This output was compared pre- and post- 6 week dosing with study medication." (NCT04510922)
Timeframe: 6 weeks

Gait Analysis - Single Leg Stance Time

Using a gait mat, participants were instructed to walk self-paced along the mat. The sensors in the mat automatically extracted the percentage of time a participant stood on a single leg. The output was compared pre- and post- 6 week dosing with study medication. (NCT04510922)
Timeframe: 6 weeks

Gait Analysis - Stride Length

Measured in cm (NCT04510922)
Timeframe: 1 month

Orthostatic Hypotension Questionnaire (OHQ) Score

Orthostatic Hypotension Symptom Assessment (OHSA; Range: 0-10) and Orthostatic Hypotension Daily Activities Scale (OHDAS; Range: 0-10) 10 items measured on a Likert-scale with 10 being the worst possible score. (NCT04510922)
Timeframe: 1 month

PDQ-39 Score

"The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living including mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.~The scale consists of 39 items ranked on a 5-point ordinal scale (Never=0, Occasionally=1, Sometimes=2, Often=3, Always=4).~Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better Quality of Life.~Dimension score = sum of scores of each item in the dimension divided by the maximum possible score of all the items in the dimension, multiplied by 100.~Overall score = sum of dimension total scores divided by 8.~Scores were compared pre- and post- 6 weeks dosing with medication." (NCT04510922)
Timeframe: 6 weeks

Postural Analysis - Postural Sway

Using a gait mat, postural sway was measured in cm on the X-axis while participants were asked to stand eyes open and eyes closed for 30 seconds. This output was compared pre- and post- 6 weeks dosing with study medication. (NCT04510922)
Timeframe: 6 weeks

Tinetti Score

"he Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's gait and balance abilities. Scoring: Items are scored either 0-1 or 0-2. 0 indicates the highest level of impairment, whereas a higher score (1 or 2) indicates the individuals independence.~There were 17 tasks (one task split into two sub-items and scored twice) that the scores were summed for a highest possible score of 28 (10 items scored on a 0-1 scale, and 8 items scored on a 0-2 scale).~The Tinetti assessment was compared pre- and post- 6 week medication dosing." (NCT04510922)
Timeframe: 6 weeks

24-h Urinary Norepinephrine Excretion

Norepinephrine concentration determined from a 24-hour urine sample in a bottle shielded from light containing preservative. Patients will be instructed to refrigerate their sample and bring it on the morning of their visit in a cool bag. (NCT02553265)
Timeframe: up to Week 14

Average Systolic Blood Pressure Variability (Daytime)

Patients with FD undergo ambulatory BP monitoring while keeping a detailed log of their activities (sleep/meal-times/medications/posture/symptoms). Variability in blood pressure overtime will be measured by the standard deviation during awake hours (NCT02553265)
Timeframe: up to Week 14

Coefficient of Systolic BP Variability (Daytime)

The measurement of blood pressure variability based on the standard deviation that also takes into account the underlying level of BP. (NCT02553265)
Timeframe: up to Week 14

Frequency of Worsening Symptoms Noted in the Patient's Diary

A tailored questionnaire to examine symptoms over the treatment period and the used of as needed medications. Each day will have a designated page. Since nausea/vomiting and hypertension occur together in FD we will use a diary consisting of a simplified version of the Rhodes Index 44 symptoms of nausea/retching, with items addressing vomiting/throwing up omitted, as most participants will have had anti-reflux surgery to prevent vomiting (fundoplication), graded on a 5-point scale (appendix 2). The diary will also include space to write down any adverse events on a daily basis. (NCT02553265)
Timeframe: Up to 90 Days

Heart Rate

Heart rate in the seated position (NCT02553265)
Timeframe: up to Week 14

Highest Systolic Blood Pressure

Maximum blood pressure captured on 24-h ambulatory monitoring (NCT02553265)
Timeframe: Day 1 of treatment period

Morning Surge in Systolic BP on Awakening From Sleep (24-h)

The morning surge will be calculated as the difference between the mean systolic blood pressure during the hour that included the lowest blood pressure during sleep and maximum value detected within 2-h of awakening from sleep (NCT02553265)
Timeframe: up to Week 14

Number of Participants Who Displayed Clinical Significant Laboratory Values on CBC or Metabolic Panel

Clinically significant laboratory values include complete blood count (CMC) and metabolic panel related to treatment with carbidopa (NCT02553265)
Timeframe: Up to 90 days

Number of Participants Who Displayed Clinically Significant Values in Urine Safety Parameters

Clinically significant values on urinalysis, urine safety parameters related to treatment with carbidopa (NCT02553265)
Timeframe: Up to 90 days

Number of Participants Who Reported Adverse Events Related to Study Drug

Adverse events defined as: a change in a patient's baseline condition including intercurrent illnesses irrespective of the relationship to carbidopa treatment. This will be monitored primarily with phone calls at weekly intervals. In addition, patients will be asked about adverse events while at the office. Patients will also fill a daily diary with a specific prompts to note any adverse events. (NCT02553265)
Timeframe: Up to 90 days

Number of Participants Who Reported Worsening of OH Symptoms or Dropped Out Because of Worsening OH While on Active Study Drug

(NCT02553265)
Timeframe: Up to 90 days

Number of Participants With Abnormal Electrocardiographic Interval Patterns

Clinically significant changes in the intervals of characteristic electrocardiographic patterns (NCT02553265)
Timeframe: Up to 90 days

Number of Participants With Significant Changes in Body Mass That Resulted in Discontinuation From the Study.

Body mass measured in kg (NCT02553265)
Timeframe: Up to 90 days

Severity of Hypotension During an Active Stand Test

Lowest blood pressure captured during 3 minutes of standing (NCT02553265)
Timeframe: up to Week 14

Systolic Blood Pressure

SBP measured in the seated position (NCT02553265)
Timeframe: up to Week 14

Change of the Depression Score (Beck Depression Inventory-II )

"Change of the depression score after 3-month medical treatment compared to initial results.~21 multiple-choice questions, each of which can be scored from 0 to 3. Higher score represent higher degree of depression.~Score Normal; 0-13, Mild depression; 14-19, Moderate depression; 20-28, Severe depression; 29-63" (NCT02308124)
Timeframe: after 3-month medical treatment.

Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).

"Change of the OH associated symptom survey result after 3-month medical treatment compared to initial results.~OHQ questionnaire has two components: the OH daily activity scale (OHDAS), which contains 4 items measuring the impact of OH on daily activities, and the OH symptom assessment (OHSA), which contains 6 items measuring the symptoms of OH (dizziness/light headedness, vision disturbance, weakness, fatigue, trouble concentrating, and head/neck discomfort).This questionnaire reflects the severity of OH-related symptoms on a 10-point scale, with 0 indicating the absence of a symptom and 10 indicating maximal severity.~** OHQ total score minimal 0 ~ maximal 100" (NCT02308124)
Timeframe: after 3-month medical treatment.

Changes in Health-related Quality of Life

"changes in Short Form (36) Health Survey version 2 (SF-36v2) mental component summary scale (MCS)~SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores." (NCT02308124)
Timeframe: changes at 3 months after treatment

Short-form 36 Version 2

"changes in Short Form (36) Health Survey version 2 (SF-36v2) physical component summary scale (PCS) compared to the baseline~SF-36v2 measures eight HRQOL domains (physical functioning, role limitation caused by physical problems, bodily pain, general health, vitality, social functioning, role limitation caused by emotional problems, and mental health) summarized into two summary scales that are normalized to the population (mean=50, standard deviation=10): the physical component summary scale (PCS) and the mental component summary scale (MCS).20 Better HRQOL is reflected by higher SF-36v2 scores." (NCT02308124)
Timeframe: changes at 3 months after treatment

Change in Orthostatic BP Drop

Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results. (NCT02308124)
Timeframe: after 3-month medical treatment

Reviews

1 review available for midodrine and Autonomic Failure, Progressive

Trials

2 trials available for midodrine and Autonomic Failure, Progressive

Other Studies

4 other studies available for midodrine and Autonomic Failure, Progressive