Table 2.
Clinical trials where the effects of DA and DA agonists or derivatives are being studied in non-CNS diseases as possible drugs or adjuvants.
| Intervention | Condition or Disease | Study Design and Location | Outcome Measures |
|---|---|---|---|
| Sepsis or septic shock | |||
| DA (5–20 μg/kg/min to predetermined max of 20) | Septic shock | Interventional, randomized, parallel, assignment N = 252 Location: United States |
Efficacy, safety, arrhythmia (28 days) [166] |
| DA (Start at 5 μg/kg/min, increase every 16–30 min by 5 μg/kg/min to a maximum dose of 15 μg/kg/min or adequate response) | Late-onset neonatal sepsis Extreme prematurity neonatal hypotension |
Observational, prospective N = 550 Location: Canada |
Mortality, severe neurological injury (assessed up to a maximum of 36 weeks after date of birth) Treatment failure rate (Time frame: 90 min) Bronchopulmonary dysplasia, retinopathy, and prematurity (Time: frame: 36 weeks postmenstrual age) Length of hospital stay [167] |
| DA (8 μg/kg/min, increasing the dose after 15 min to 12 μg/kg/min to a maximum of 15 μg/kg/min) | Shock Hypovolemic Septic Shock |
Interventional, randomized, parallel, assignment N = 135 Location: Bangladesh |
Case fatality rate (Time frame: 28 days) Treatment failure rates, need of mechanical ventilation, heart failure, length of ICU stay and heart function (Time frame: 7 days) [168] |
| Renal failure | |||
| Fenoldopam (D1 agonist) | Acute renal failure | Interventional, randomized, single group assignment Location: United States |
Incidence of death or dialysis at 21 days Peak serum creatinine and duration of ICU stay [169] |
| DA (dose of 4 μg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery) | Renal failure Transplant renal failure |
Interventional, randomized, parallel assignment N = 60 Location: Egypt |
Post-operative creatinine clearance (Time frame: 7 days) [170] |
| Ropinirole (0.50 mg capsule, once daily for 4 weeks) | End stage renal disease | Interventional, randomized, crossover Assignment N = 52 Location: Canada |
Quality of life scale patient global impressions (Time frame: 18 weeks) [171] |
| Fenoldopam. 60 μg/mL; 0.1 mL/h to provide 0.1 μg/kg/min). If, after 6 h there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion will be increased to 0.2 mL/kg/h (0.2 μg/kg/min for infants receiving fenoldopam). This rate will be continued throughout the remainder of the study | Acute kidney injury Patent ductus arteriosus |
Interventional, randomized, parallel assignment N = 1 Location: United States |
Changes in urine output (mL/kg/h) and serum levels of fenoldopam during infusion of the drug and following discontinuation of the drug will be measured by liquid chromatography and mass spectrometry (Time frame: 60 h) Change in levels of serum albumin, β-2 macroglobulin, epidermal growth factor, osteopontin, uromodulin cystatin C and in serum creatinine (mg/dL) (Time frame: 48 h) [172] |
| Fenoldopam (continuous intravenous infusion of 0.3 μg/kg/min fenoldopam for 24 h) | Acute renal failure | Interventional, randomized, parallel assignment N = 80 Location: Poland |
Cystatin C and Neutrophil Gelatinase-Associated Lipocalin (NGAL) in serum (Time frame: after 24 and 48 h) [173] |
| Fenoldopam (continuous infusion at 1 μg/kg/min during cardiopulmonary bypass) | Acute renal failure | Interventional, randomized, parallel assignment N = 80 Location: Italia |
Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls (Time frame: end of surgery and 12 h postoperatively) [174] |
| Fenoldopam. 0.1 μg/kg/min (from 0.025 to 0.3 μg/kg/min) for up to 4 days | Acute renal failure | Interventional, randomized, parallel assignment N = 667 Location: Italia |
Number of patients requiring Renal Replacement Therapy (Time frame: participants will be followed for the duration of intensive care unit stay, an expected average of one week). Number of dead patients (Time frame: Participants will be followed for 1 year) [175] |
| Gastric diseases | |||
| Domperidone (DA agonist)(10–30 mg oral dose, four times daily) | Gastroesophageal reflux Gastroparesis Chronic constipation |
Expanded Access Location: United States |
Unspecified data [176] |
| Domperidone (10 mg administered 2–4 times a day as needed) | Gastroparesis Esophagitis Dyspepsia Chronic idiopathic Constipation Nausea Vomiting |
Interventional, randomized, single group assignment N = 42 Location: United States |
Relief for patients with gastrointestinal disorders who have failed standard therapy (Time frame: if the subjects continue to take domperidone) [177] |
| Disease in ovarian and Cushing’s disease | |||
| Cabergoline (0.5 mg/day for 8 days) | Polycystic ovarian syndrome | Interventional, nonrandomized, single group assignment N = 40 Location: Turkey |
Concentrations of follicular fluid antimullerian hormone (Time frame: 1 year) [178] |
| Quinagolide (DA Agonist) (200 μg/day) | Ovarian hyperstimulation syndrome | Interventional, randomized, parallel assignment N = 30 Location: Spain |
Tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing ovarian hyperstimulation syndrome (Time frame: 21 days) [179] |
| Cabergoline (1 mg/week in divided doses, increased by 1 mg/week every month, to the maximum of 5 mg/week. If response is seen than the dose at which response is seen is continued until the end of the study) | Cushing’s disease | Interventional, nonrandomized, single group assignment Location: India |
Response in term of mid night cortisol < 5.0 μg/dL and/or Standard two-day dexamethasone suppression test < 1.8 μg/dL [180] |
| Diabetes | |||
| Bromocriptine | Type 1 diabetes Cardiovascular disease |
Interventional, randomized, crossover assignment N = 108 Location: United States |
Mean glucose, insulin dosing, brachial artery distensibility, hyperemia, peripheral arterial tonometry (Time frame: 4 weeks) [181] |
| Bromocriptine (1.6–3.2 mg/day) | Diabetes autonomic neuropathy | Interventional, randomized, parallel assignment N = 84 Location: United States |
Changes in expiration/inspiration ratio, in bromocriptine ratio, in electrochemical skin conductance and in heart rate variability (Time frame: 24 weeks) [182] |
| Cabergoline (0.5 mg per week) | Diabetes type 2 | Interventional, randomized, single group assignment N = 10 Location: Iran |
Fasting blood sugar and glycosylated hemoglobin (Time frame: 30 days) [183] |
| Bromocriptine (2.4–3.2 mg/day) | Diabetes type 2 | Interventional, randomized, single group assignment N = 23 Location: United States |
Glucose metabolism during mixed meal tolerance test (Time frame: 5 weeks) [184] |
| Bromocriptine | Insulin sensitivity | Interventional, randomized, crossover assignment N = 15 Location: Netherlands |
Timing of administration of bromocriptine. Difference in insulin sensitivity between lean and obese males before and after the use of bromocriptine Difference in energy expenditure in lean and obese before and after the use of bromocriptine. (Time frame: 6 weeks) [185] |
| Obesity or overweight | |||
| Bromocriptine (1.6 mg) | Obesity and overweight Eating behavior |
Interventional, randomized, crossover assignment N = 55 Location: United States |
Ad libitum food intake (Time frame: within 15 min of completion of the ad libitum period), hedonic ratings (Time frame: within 5 min prior to ad libitum period), change in blood oxygen (Time frame: 2 weeks) [186] |
| Bromocriptine (1.25 mg/day during the first week and 2.5 mg/day during the second week) | Obesity | Interventional, randomized, single group assignment N = 8 Location: Netherlands |
Difference in 18F-fluorodeoxyglucose uptake, in energy expenditure, in core body temperature and in in insulin sensitivity before and after using bromocriptine (Time frame: 17 months) [187] |
| Cabergoline (0.5 mg twice weekly) | Body weight Glucose tolerance |
Interventional, randomized, parallel assignment N = 40 Location: United States |
Body weight and glucose (Time frame: 16 weeks) [188] |
| Fibromyalgia | |||
| Bromocriptine (single dose of bromocriptine 1.25 mg) | Fibromyalgia | Interventional, randomized, crossover assignment N = 100 Location: Switzerland |
Brain metabolites (Time frame: Only in sub study 1: 12 to 30 min) Blood oxygen level dependent (BOLD) responses (Time frame: 12 to 45 min) Sensory and emotional pain responses (Time frame: 12 to 20 min) [189] |
| Rotigotine (DA agonist; 4 mg/24 h) | Fibromyalgia | Interventional, randomized, parallel assignment N = 230 Location: United States |
Change from baseline in average daily pain score to the last 2 weeks of the 12-week treatment phase change from baseline in average daily pain score to the last 2 weeks of the 12-week treatment phase (Based on the Per Protocol Set) (Time frame: baseline, last 2 weeks of the 12-week treatment phase) [190] |
| Ropinirole | Fibromyalgia | Interventional, randomized, parallel assignment N = 164 Locations: Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Sweden, United Kingdom |
Change in pain intensity score from baseline to last week of treatment (week 12). Pain severity and impact on physical function, sleep quality, tender point pressure threshold [191] |
| Pramipexole (0.75 mg to 4.5 mg tablets once daily in the evening) | Fibromyalgia | Interventional, randomized, parallel assignment N = 61 Location: United States |
Change in the weekly mean of the 24 h average pain score from a daily diary as measured by the 11-point Likert pain scale (Time frame: week 29) [192] |
| Blood pressure | |||
| Fenoldopam (0.05 μg/kg/min for 3 h) | Hypertension | Interventional, randomized, crossover assignment N = 44 Location: United States |
Urine sodium excretion (Time frame: 7 days) [193] |
| Fenoldopam (0.5 μg/kg/min for 3 h) | Salt-sensitive hypertension | Interventional, randomized, crossover assignment N = 45 Location: United States |
Urinary sodium excretion (Time frame: 3 h) [194] |
| DA (beginning at 5 μg/kg/min and titrated by 5 μg/kg/min to effect up to maximum of 20 μg/kg/min) | Hypotension | Interventional, randomized, parallel assignment N = 70 Location: United States |
Number of subjects in each group who have achieved an optimal mean blood pressure value at 24 h of life (Time frame: 24 h) [195] |
| Cancer | |||
| Cabergoline (total week dose of 3.5 mg, starting 6 months after of ranssphenoidal surgical) | Pituitary adenoma | Interventional, randomized, single group assignment N = 140 Location: Brazil |
Tumor shrinkage (time frame: 24 months) [196] |
| Ropirinole (0.25 mg/day–6.0 mg/day oral) | Prolactinoma | Interventional, single group assignment N = 16 Location: United States |
Percentage of subjects that achieved stable prolactine normalization (Time frame: 6–12 months) [197] |
| Cabergoline (twice weekly for weeks 1 to 4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity) | Breast cancer | Interventional, single group assignment N = 20 Location: United States |
Overall Response Rate at 2 Months [198] |
| Others | |||
| Cabergoline (1.0, 2.0 and 3.5 mg/week) | Acromegalia | Observational, case only, prospective N = 19 Location: Brazil |
IGF-I, GH and prolactin levels (Time frame: 6 months) [199] |
| Cabergoline | Adverse reaction to other drugs and medicines | Interventional, randomized, single group assignment N = 48 Location: Turkey |
Effect of prolactin vascular flow and resistance (Time frame: the effect of prolactin in vascular resistance at 2 weeks after treatment) [200] |