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Last Updated: March 24, 2025

CLINICAL TRIALS PROFILE FOR PARLODEL


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All Clinical Trials for PARLODEL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT02428946 ↗ Bromocriptine and Insulin Sensitivity Completed Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) N/A 2014-10-01 In this study the investigators will examine the effect of dopamine (bromocriptine) on insulin sensitivity in lean and obese subjects. Furthermore, the investigators will examine whether the timing of bromocriptine administration has influence on insulin sensitivity. To do so, the investigators will include lean and obese subjects who will use 2 times 2 weeks bromocriptine. In randomized order, they will use it in the morning or in the evening. The investigators will examine insulin sensitivity by performing a 7-point oral glucose tolerance test. Furthermore, the investigators will examine energy expenditure and subjects will keep track of their eating behaviour in the 3 days before each study visit.
NCT02428933 ↗ Dopaminergic Effects on Brown Adipose Tissue Completed Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) N/A 2013-10-01 In this study the investigators will investigate the effect of dopamine (bromocriptine) on Brown Adipose Tissue in lean, young, healthy males. The investigators will also examine energy expenditure, body temperature and insulin sensitivity as measurements of Brown Adipose Tissue activity.
NCT01821001 ↗ Vaginal Bromocriptine for Treatment of Adenomyosis Completed Mayo Clinic Phase 1 2013-03-01 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.
NCT00605683 ↗ MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist Completed Newron Phase 3 2007-11-01 Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
NCT00605683 ↗ MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist Completed Newron Pharmaceuticals SPA Phase 3 2007-11-01 Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
NCT00650520 ↗ Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets Completed Mylan Pharmaceuticals Phase 1 2007-05-01 The objective of this study is to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 2.5 mg bromocriptine mesylate tablets, following the administration of a 10 mg dose, under fed conditions.
NCT00649168 ↗ Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg Completed Mylan Pharmaceuticals Phase 1 2007-04-01 The objective of this study was to assess the single-dose relative bioavailability of Mylan Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation (Parlodel®) 5 mg bromocriptine mesylate capsules, following the administration of a 10 mg dose, under fed conditions.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for PARLODEL

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2HealthySubarachnoid HemorrhageAdenomyosisSubdural Hematoma[disabled in preview]
Condition Name for PARLODEL
Intervention Trials
Healthy 2
Subarachnoid Hemorrhage 1
Adenomyosis 1
Subdural Hematoma 1
[disabled in preview] 0
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Condition MeSH

11110-0.100.10.20.30.40.50.60.70.80.911.1Hematoma, SubduralAnorexia NervosaInsulin ResistanceHematoma[disabled in preview]
Condition MeSH for PARLODEL
Intervention Trials
Hematoma, Subdural 1
Anorexia Nervosa 1
Insulin Resistance 1
Hematoma 1
[disabled in preview] 0
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Clinical Trial Locations for PARLODEL

Trials by Country

+
Trials by Country for PARLODEL
Location Trials
United States 22
Canada 4
South Africa 3
Netherlands 2
Germany 1
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Trials by US State

+
Trials by US State for PARLODEL
Location Trials
California 4
Pennsylvania 2
Minnesota 1
Texas 1
Rhode Island 1
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Clinical Trial Progress for PARLODEL

Clinical Trial Phase

20.0%10.0%10.0%60.0%00.511.522.533.544.555.566.5Phase 4Phase 3Phase 1/Phase 2[disabled in preview]
Clinical Trial Phase for PARLODEL
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 1/Phase 2 1
[disabled in preview] 6
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Clinical Trial Status

80.0%10.0%10.0%0012345678CompletedNot yet recruitingRecruiting[disabled in preview]
Clinical Trial Status for PARLODEL
Clinical Trial Phase Trials
Completed 8
Not yet recruiting 1
Recruiting 1
[disabled in preview] 0
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Clinical Trial Sponsors for PARLODEL

Sponsor Name

trials011223344556University of California, San FranciscoAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University of California, Berkeley[disabled in preview]
Sponsor Name for PARLODEL
Sponsor Trials
University of California, San Francisco 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 2
University of California, Berkeley 2
[disabled in preview] 5
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Sponsor Type

66.7%26.7%6.7%0-101234567891011OtherIndustryNIH[disabled in preview]
Sponsor Type for PARLODEL
Sponsor Trials
Other 10
Industry 4
NIH 1
[disabled in preview] 0
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Parlodel (Bromocriptine Mesylate): Clinical Trials, Market Analysis, and Projections

Introduction

Parlodel, also known as bromocriptine mesylate, is a dopamine agonist used in the treatment of various medical conditions, including hyperprolactinemia, acromegaly, and Parkinson’s disease. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Uses of Parlodel

Hyperprolactinemia

Parlodel is indicated for the treatment of dysfunctions associated with hyperprolactinemia, such as amenorrhea, galactorrhea, infertility, and hypogonadism. It is particularly effective in patients with prolactin-secreting adenomas, reducing tumor size in both male and female patients[1][2][5].

Acromegaly

In the treatment of acromegaly, Parlodel reduces serum growth hormone levels by 50% or more in approximately half of the patients treated, although not usually to normal levels. It is often used as adjunctive therapy with pituitary irradiation or surgery[1][2].

Parkinson’s Disease

Parlodel is used as an adjunctive treatment to levodopa (alone or with a peripheral decarboxylase inhibitor) for the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease. It helps in reducing the maintenance dose of levodopa and mitigating adverse reactions associated with long-term levodopa therapy, such as dyskinesias and the "on-off" phenomenon[1][2].

Current Clinical Trials

REBIRTH Trial

One notable ongoing clinical trial is the Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy (REBIRTH) for Peripartum Cardiomyopathy. This Phase 4 trial aims to evaluate the efficacy of bromocriptine in improving left ventricular ejection fraction (LVEF) and reducing major cardiac events in women with peripartum cardiomyopathy. The trial will follow patients for up to 3 years post-randomization and assess outcomes such as survival free from major cardiac events and heart failure hospitalization[4].

Adverse Reactions and Safety Profile

Clinical trials and post-marketing reports have highlighted several adverse reactions associated with Parlodel. Common adverse reactions include nausea, abnormal involuntary movements, hallucinations, confusion, dizziness, drowsiness, faintness, fainting, and syncope. Patients with Parkinson’s disease are particularly at risk of sudden sleep onset without warning signs, which necessitates caution when engaging in activities requiring rapid and precise responses[1][2].

Market Analysis

Market Position

Parlodel has been a staple in the treatment of hyperprolactinemia and acromegaly for several decades. Its use in Parkinson’s disease, although adjunctive, provides significant therapeutic benefits by reducing the need for higher doses of levodopa and mitigating its associated adverse effects.

Competition

The market for dopamine agonists is competitive, with other drugs like cabergoline and ropinirole also being used for similar indications. However, Parlodel's long-standing presence and established efficacy profile maintain its market relevance.

Patient Population

The patient population for Parlodel is diverse, including those with hyperprolactinemia, acromegaly, and Parkinson’s disease. The REBIRTH trial, if successful, could expand the drug's use to include patients with peripartum cardiomyopathy, potentially increasing its market share.

Market Projections

Growth Potential

Given the ongoing clinical trials and the potential expansion into new indications, Parlodel is expected to maintain a stable market presence. The REBIRTH trial, in particular, could lead to increased usage if it demonstrates significant benefits in treating peripartum cardiomyopathy.

Challenges

One of the challenges facing Parlodel is the availability of generic alternatives, which could impact its market share. Additionally, the emergence of new treatments for hyperprolactinemia, acromegaly, and Parkinson’s disease could pose competition.

Key Takeaways

  • Clinical Uses: Parlodel is effective in treating hyperprolactinemia, acromegaly, and Parkinson’s disease.
  • Current Trials: The REBIRTH trial is evaluating bromocriptine's efficacy in peripartum cardiomyopathy.
  • Adverse Reactions: Common adverse effects include nausea, dizziness, and sudden sleep onset.
  • Market Position: Parlodel remains a significant player in its therapeutic areas despite competition.
  • Growth Potential: Successful clinical trials could expand its market share.

FAQs

What are the primary indications for Parlodel?

Parlodel is primarily indicated for the treatment of hyperprolactinemia, acromegaly, and Parkinson’s disease.

What are the common adverse reactions associated with Parlodel?

Common adverse reactions include nausea, abnormal involuntary movements, hallucinations, confusion, dizziness, drowsiness, faintness, and syncope.

Is Parlodel used in the treatment of peripartum cardiomyopathy?

Parlodel is currently being evaluated in the REBIRTH trial for its efficacy in treating peripartum cardiomyopathy.

How does Parlodel affect tumor size in patients with prolactin-secreting adenomas?

Parlodel has been shown to reduce tumor size in both male and female patients with macroadenomas.

Can Parlodel be used as a standalone treatment for Parkinson’s disease?

Parlodel is typically used as an adjunctive treatment to levodopa for Parkinson’s disease, rather than as a standalone treatment.

Sources

  1. RxList: Parlodel (Bromocriptine Mesylate): Side Effects, Uses ...
  2. FDA: PARLODEL SnapTabs DESCRIPTION
  3. Newron: vL Newron Valuation Report 3JAN23.pdf
  4. UF Health: REBIRTH - UF Health
  5. MedlinePlus: Bromocriptine: MedlinePlus Drug Information

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