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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR CYCLOSET

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Clinical Trials for Cycloset

Trial ID Title Status Sponsor Phase Summary
NCT00377676 Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes Completed VeroScience Phase 3 Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well.
NCT00441363 Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin Terminated VeroScience Phase 3 The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.
NCT01821001 Vaginal Bromocriptine for Treatment of Adenomyosis Active, not recruiting Mayo Clinic Phase 1 Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as a therapy based on animal models of the disease and our prior clinical research to observe any objective improvement in the extent of the disease using Magnetic Resonance Imaging (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.
NCT02078440 Pharmacokinetic Study of CYCLOSET ® 0.8 mg Tablets in Children and Adolescent Type 2 Diabetes Mellitus Subjects Completed VeroScience Phase 1 The objective of this study is to evaluate the relative bioavailability, and the rate and extent of absorption of bromocriptine in male and female children and adolescent Type 2 Diabetes Mellitus patients, aged 10 to less than 18, under fed conditions. It is undetermined if the pharmacokinetic profile of bromocriptine-QR in type 2 diabetes children aged 10- to less than 18 years differs appreciably from that in healthy adults. Bromocriptine is extensively metabolized by the liver (namely CYP3A4). Studies in children have demonstrated little difference in clearance among children over 10 years of age compared to adults (Blanco et al, 2000). However, differences in blood volumes or other factors may impart differences that could affect the pharmacokinetic properties of bromocriptine-QR. Therefore, this study will assess the pharmacokinetics in children aged 10-to less than 18 years who have type 2 diabetes. After describing the profile of bromocriptine-quick release in this patient population, a follow on study will be conducted to evaluate its safety and efficacy in treating children and adolescents who have type 2 diabetes. The pharmacokinetic profile of bromocriptine will be determined following the administration of a single, weight-adjusted dose of CYCLOSET (bromocriptine mesylate) tablets. The study will be a single period, bioavailability study in 30 patients. The study duration will be 3 days.
NCT02133755 Effect of Bromocriptine on Insulin Resistance in Polycystic Ovarian Syndrome - A Pilot Study Unknown status IWK Health Centre Phase 3 The primary aim of this study is to determine the effect of dopamine agonist therapy on insulin resistance in lean vs. obese women with polycystic ovary syndrome. Polycystic ovary syndrome (PCOS) is a common metabolic abnormality in women. The diagnosis of PCOS relies on a constellation of symptoms and signs (problems with ovulation, clinical and/or biochemical signs of hyperandrogenism and cystic ovaries). Though not a diagnostic feature, insulin resistance (IR) is a hallmark of PCOS and up to 80% women with PCOS have IR. Although IR is more significant in obese women with PCOS, even lean women can be insulin resistant. No current therapy addresses the problem of insulin resistance in PCOS. Studies have suggested a dopamine deficiency in patients with PCOS, which may underlie the insulin resistance and may have a pathogenetic role in the development of PCOS. No study to date has assessed the impact of dopamine agonist therapy on IR in patients with PCOS.
NCT02299050 Effect of Cycloset on Glycemic Control When Added to GLP-1 Analogue Therapy Recruiting VeroScience Phase 4 Purpose This study will examine the effect of the addition of Cycloset upon glucose metabolism (glycemic control including post prandial glucose metabolism) in individuals with inadequately controlled (HbA1c 7.5-10.0) type 2 diabetes (T2DM) who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide once daily) as part of their standard care. Both a mechanistic rationale and empirical experimental evidence implicate a beneficial interaction between bromocriptine and the incretin mimetics (GLP-1 analogs) upon postprandial hyperglycemia in insulin resistant states. One of the actions of the incretin mimetics such as the GLP-1 analogs is to stimulate postprandial beta cell insulin secretory response to plasma glucose (see drug labeling information; www.fda.gov). Thus the combination of Cycloset that is working as a post prandial insulin sensitizier with therapies that increase post prandial insulin would be expected to provide complimentary glucose lowering effects. To date, however, no such studies investigating the interactive effects of a GLP-1 analog and Bromocriptine-QR (Cycloset) have been conducted in humans. Condition - Type 2 Diabetes. Intervention - Cycloset. Phase - Phase 4 Study Type: Interventional Study Design: Treatment, Single Group Assignment, Open Label, N/A, Safety/Efficacy Study Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled on GLP-1 Analogue Therapy
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cycloset

Condition Name

Condition Name for Cycloset
Intervention Trials
Type 2 Diabetes 3
Insulin Resistance 1
Adenomyosis 1
Type 2 Diabetes Mellitus 1
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Condition MeSH

Condition MeSH for Cycloset
Intervention Trials
Diabetes Mellitus, Type 2 4
Diabetes Mellitus 2
Polycystic Ovary Syndrome 1
Insulin Resistance 1
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Clinical Trial Locations for Cycloset

Trials by Country

Trials by Country for Cycloset
Location Trials
United States 7
Canada 1
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Trials by US State

Trials by US State for Cycloset
Location Trials
Pennsylvania 1
Missouri 1
Florida 1
Connecticut 1
Arizona 1
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Clinical Trial Progress for Cycloset

Clinical Trial Phase

Clinical Trial Phase for Cycloset
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Cycloset
Clinical Trial Phase Trials
Completed 2
Active, not recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Cycloset

Sponsor Name

Sponsor Name for Cycloset
Sponsor Trials
VeroScience 4
Mayo Clinic 1
The University of Texas Health Science Center at San Antonio 1
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Sponsor Type

Sponsor Type for Cycloset
Sponsor Trials
Industry 4
Other 3
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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Julphar
QuintilesIMS
McKinsey
Moodys
Chubb
Dow
Medtronic

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