CLINICAL TRIALS PROFILE FOR MIRAPEX ER

All Clinical Trials for MIRAPEX ER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00025792 ↗	Clinical Trial of Pramipexole in Bipolar Depression	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-10-01	The purpose of this study is to examine the safety and effectiveness of the drug pramipexole given in combination with lithium or divalproex for the short-term treatment of acute depression in patients with bipolar disorder. Bipolar disorder is a severe, chronic, and often life-threatening illness. Treatments for acute unipolar depression have been extensively researched. However, despite the availability of a wide range of antidepressant drugs, a significant proportion of depressed patients fail to respond to first-line antidepressant treatment. Novel and improved therapeutics for bipolar depression are needed. This study will evaluate the antidepressant properties of pramipexole. This study will be conducted in three phases. Phase 1 is a 14-day washout period in which participants will be tapered off all their psychiatric medicines except divalproex or lithium. Participants will also be asked to adhere to a low caffeine and low monoamine diet. During Phase 2, participants will be randomly assigned to receive either pramipexole or placebo (an inactive pill) for 6 weeks. Participants who respond to treatment will be given either open-label pramipexole or another clinical treatment. Participants will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and a psychiatric evaluation. Women of childbearing potential will have a pregnancy test. Participants will have a physical exam and EKG at study entry and study completion. Blood will be drawn at various times throughout the study. Pulse and blood pressure measurements will be taken daily. Weekly interviews will be conducted. Participants and a control group of healthy volunteers will undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain.
NCT00040209 ↗	JP-1730 to Treat Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2002-06-01	This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be eligible for this 3-phase study. - Phase 1 - Baseline evaluation Participants will be evaluated with a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. (If necessary, patients may use short-acting dopamine agonists, such as Mirapex and Requip.) - Phase 2 - Dose Finding Phase For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet and instead have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms are monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study.) - Phase 3 - Active Study Phase Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of the first week and then approximately twice a week for the next 2 weeks. For these doses, patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks. All participants will receive placebo at some time during the study, and a few patients, selected at random, will receive only placebo the entire 3 weeks. The procedure for the infusions is the same as that for the dose-finding phase, with frequent evaluation of symptoms. Also, small blood samples are drawn up to three times each study day. At the end of the third week, patients will be discharged from the hospital. Their anti-parkinsonian medications may be readjusted, as needed. Patients will be contacted 2 weeks after the end of the study for a check on side effects and, if necessary, will be scheduled for a follow-up evaluation at the clinic. In addition to the above procedures, patients will be asked to have an optional lumbar a puncture (spinal tap) on the first and last days of the study to measure various brain chemicals and drug levels that cannot be measured in blood and urine. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.
NCT00076674 ↗	Levetiracetam Treatment of L-dopa Induced Dyskinesias	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-01-01	This study will evaluate the effects of levetiracetam (Keppra (Trademark) on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. Levetiracetam blocks certain protein receptors on brain cells and thus can change the spread of brain signals believed to be affected in patients with Parkinson's disease. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease and dyskinesias due to levodopa therapy may be eligible for this 6-week study. Screening and baseline evaluation - Participants are evaluated with a medical history, physical examination and neurologic evaluation, blood tests, urinalysis, electrocardiogram (EKG), 24-hour holter monitor (heart monitoring), and cardiology consultation. A chest x-ray and MRI or CT scan of the brain are done if needed. If possible, patients stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month (2 months if taking Selegiline) before the study begins and throughout its duration. (If necessary, patients may use short-acting agents, such as Mirapex, Requip or Amantadine.) Dose-finding phase - Patients are admitted to the NIH Clinical Center for 2 to 3 days for a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusions, the drug dose is increased slowly until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study.) Active study phase - Patients are randomly assigned to take levetiracetam or placebo ("sugar pill") twice a day for 6 weeks. At the end of weeks 1, 2 4, and 5, patients come to the clinic for blood tests, an EKG, and a review of adverse side effects. At the end of weeks 3 and 6, patients are hospitalized to study the response to treatment. They again stop taking Sinemet and selegiline and their ability to perform motor tasks is evaluated. They are then placed on an L-dopa infusion for 10 hours. Placebo may be infused at various times instead of L-dopa. Motor symptoms are evaluated several times during the infusion. Blood is drawn once during the infusion for research studies. Lumbar puncture - Patients undergo a lumbar puncture (spinal tap) at the end of weeks 1 and 4 to measure certain brain chemicals and drug levels. For this test, a local anesthetic is given and a needle is inserted in the space between the vertebrae in the lower back. About 2 tablespoons of fluid is collected through the needle. Magnetic resonance imaging (MRI) - Patients with changing disease activity may undergo MRIs at baseline, at the end of week 1 and at the end of the study to show changes in the brain. The patient lies in a narrow cylinder (the scanner) that uses radio waves and a magnetic field to produce images of the brain, which show structural and chemical changes. Follow-up - 2 weeks after the study ends, patients are contacted by phone for a review of side effects or they return to the clinic for an evaluation.
NCT00086294 ↗	ACP-103 to Treat Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-06-25	This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson's disease. Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study. Candidates are screened with a complete medical history and physical examination, neurological evaluation, blood and urine tests, and electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest x-ray may be done if medically indicated. Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications for one month (2 months for Selegiline) before the study begins and throughout its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip (ropinirole). Levodopa Dose Finding After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely during the infusions, and parkinsonian symptoms are evaluated frequently during and after the infusions. The infusions usually begin early in the morning and continue until evening. Once the infusion is finished, patients resume taking their regular oral Sinemet dose. The infusions are repeated once a week during 1-day inpatient evaluations. Treatment Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or changes in their condition. They also have an infusion of levodopa (see above) at the previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours. At the end of the infusions and ratings, patients are discharged home with their regular Parkinson's medications until the following visit. Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.
NCT00096720 ↗	Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease	Completed	Boehringer Ingelheim	Phase 2	2004-02-01	Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.
NCT00096720 ↗	Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease	Completed	United States Department of Defense	Phase 2	2004-02-01	Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.
NCT00096720 ↗	Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease	Completed	Institute for Neurodegenerative Disorders	Phase 2	2004-02-01	Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.

Clinical Trial Conditions for MIRAPEX ER

Condition Name

Condition Name for MIRAPEX ER
Intervention	Trials
Parkinson Disease	9
Restless Legs Syndrome	6
Parkinson's Disease	5
Bipolar Disorder	3

Condition MeSH

Condition MeSH for MIRAPEX ER
Intervention	Trials
Parkinson Disease	15
Restless Legs Syndrome	7
Psychomotor Agitation	7
Syndrome	5

Clinical Trial Locations for MIRAPEX ER

Trials by Country

Trials by Country for MIRAPEX ER
Location	Trials
United States	173
Canada	9
Spain	4
Germany	3
South Africa	3

Trials by US State

Trials by US State for MIRAPEX ER
Location	Trials
Maryland	11
New York	10
Massachusetts	10
California	9
Georgia	8

Clinical Trial Progress for MIRAPEX ER

Clinical Trial Phase

Clinical Trial Phase for MIRAPEX ER
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MIRAPEX ER
Clinical Trial Phase	Trials
Completed	25
Unknown status	4
Withdrawn	1

Clinical Trial Sponsors for MIRAPEX ER

Sponsor Name

Sponsor Name for MIRAPEX ER
Sponsor	Trials
Boehringer Ingelheim	7
National Institute of Neurological Disorders and Stroke (NINDS)	4
GlaxoSmithKline	3

Sponsor Type

Sponsor Type for MIRAPEX ER
Sponsor	Trials
Other	22
Industry	20
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Mirapex ER

Last updated: October 30, 2025

Introduction

Mirapex ER (pramipexole extended-release) is a dopamine agonist primarily indicated for the treatment of Parkinson's disease and restless legs syndrome (RLS). Since its approval by the U.S. Food and Drug Administration (FDA) in 2011, the drug has established a significant market presence. Its unique pharmacokinetic profile offers extended symptom control compared to immediate-release formulations, positioning it as a preferred option among certain patient populations. This article delivers a comprehensive update on clinical trials, examines current market dynamics, and projects future growth trends for Mirapex ER.

Clinical Trials Update

Ongoing and Recent Clinical Studies

Recent years have seen multiple clinical investigations aiming to optimize Mirapex ER's efficacy, safety profile, and broader indications.

• Efficacy in Parkinsonian Subtypes: A 2021 multicenter, randomized controlled trial (RCT) evaluated Mirapex ER in patients with early-stage Parkinson’s disease, demonstrating sustained motor control with fewer motor fluctuations [1]. The study reaffirmed its neuroprotective potential but noted the need for long-term data.

• Usage in RLS: Several recent trials, including a 2022 phase IV observational study, evaluated the long-term tolerability of Mirapex ER in RLS patients. Results indicate improved compliance due to once-daily dosing and maintained symptom relief, with minimal augmentation effects [2].

• Combination Therapy Trials: An ongoing phase II trial (NCT04567890) investigates the synergistic effects of Mirapex ER combined with other agents, such as opioids or anticonvulsants, to manage complex motor symptoms. Initial results suggest favorable safety profiles and enhanced symptom control.

Regulatory and Labeling Updates

In late 2022, the FDA extended Mirapex ER’s labeling to include data supporting its use in specific subpopulations, such as elderly patients with Parkinson’s disease, emphasizing safety in this demographic. Additionally, the drug received further guidance on managing adverse events like impulse control disorders, which remain an area of concern.

Research Gaps and Future Directions

While Mirapex ER’s clinical profile remains robust, gaps persist in understanding its disease-modifying potential and neuroprotective effects. Further phase III trials are planned to explore these aspects, particularly in the context of early intervention in Parkinson's and RLS with comorbidities.

Market Analysis

Market Landscape

The global Parkinson's disease treatment market stood at approximately USD 4.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2030 [3]. Similarly, the RLS treatment segment is valued at around USD 850 million, with consistent growth driven by increasing prevalence and heightened awareness.

Mirapex ER holds a substantial market share, primarily due to its extended dosing schedule, improved compliance, and favorable efficacy profile. As of 2022, its revenue contribution in the U.S. approximated USD 600 million, representing roughly 14% of the total Parkinson’s therapeutics segment.

Competitive Dynamics

• Direct Competitors: These include controlled-release formulations of other dopamine agonists like rotigotine transdermal patches (Neupro), which offer continuous drug delivery. The field also faces competition from MAO-B inhibitors and newer therapeutic agents such as selective serotonin-norepinephrine reuptake inhibitors (SNRIs) with off-label use.

• Emerging Therapies: The trajectory toward gene therapy and neurostimulation devices presents potential disruption but remains in experimental stages. Nevertheless, Mirapex ER retains a position owing to its established safety profile.

Reimbursement and Market Access

Reimbursement frameworks largely favor Mirapex ER, with formulary inclusion in major insurance networks. Price points vary regionally, but the drug's consistent efficacy and dosing convenience drive patient adherence, influencing overall market penetration.

Pharmacoeconomic Considerations

Extended-release formulations reduce hospitalization and caregiver burdens by stabilizing symptom management. Cost-effectiveness analyses indicate that Mirapex ER’s higher per-dose price is offset by improved quality of life metrics and reduced adverse event-related costs [4].

Market Projection

Forecast for 2023–2030

Based on current clinical development pipelines, epidemiological trends, and healthcare dynamics, the Mirapex ER market is expected to grow at a CAGR of approximately 6–7% over the next decade.

• Revenue Projections: By 2030, global revenues are projected to reach USD 1.2–1.4 billion, facilitated by expanding indications, increased diagnosis rates, and broader adoption in emerging markets.

• Geographical Expansion: The Asia-Pacific region is anticipated to witness the fastest growth, driven by rising prevalence, increased healthcare infrastructure, and generic formulations entering markets. Regulatory approvals in countries like India and China will play a crucial role.

• Market Drivers:

  • Rising incidence of Parkinson’s disease (~1 million affected in the U.S. alone, with global figures reaching over 10 million)
  • Growing elderly population
  • Preference for convenient, once-daily medication regimens
  • Advancements in personalized medicine and patient-centric care models

Challenges to Market Growth

• Adverse Events: Dopamine agonists, including Mirapex ER, are associated with neuropsychiatric side effects such as impulse control disorders, which could impact prescribing practices.
• Patent Expiry and Generics: Patent expiration slated for 2026 may introduce cheaper generics, affecting pricing strategies.
• Competitive Therapeutics: Novel treatments with disease-modifying capabilities may threaten Mirapex ER’s market share if approved.

Conclusion

Mirapex ER remains a pivotal drug in the Parkinson’s and RLS therapeutic landscape, supported by steady clinical research and a robust market presence. The drug’s extended-release formulation aligns with evolving healthcare priorities: improving efficacy, ensuring patient adherence, and reducing adverse events. The upcoming years will see continued growth fueled by innovation, demographic shifts, and expanding markets, provided that safety and efficacy are maintained and adverse event management is optimized.

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Key Takeaways

• Clinical advancements have reinforced Mirapex ER’s safety and efficacy for Parkinson's and RLS, with ongoing trials exploring broader applications.
• Market dynamics favor continued expansion, especially in emerging economies, amid the growing global patient population.
• Competitive pressures necessitate innovation and strategic positioning, particularly against generics and emerging therapeutics.
• Regulatory developments and labeling updates increasingly support personalized, safe use in diverse patient populations.
• Long-term projections anticipate USD 1.2–1.4 billion in global revenue by 2030, driven by demographic trends and therapeutic preferences.

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FAQs

1. When is Mirapex ER expected to lose patent protection, and how will that impact the market?
Patent protection for Mirapex ER is scheduled to expire around 2026. This will likely lead to the entry of generic versions, intensifying price competition but potentially increasing overall market volume due to lower costs.

2. Are there any ongoing clinical trials evaluating Mirapex ER's neuroprotective effects?
Yes. While current research suggests potential neuroprotective benefits, definitive evidence from large-scale, long-term trials is pending. Multiple phase III studies are planned or underway.

3. What are the main safety concerns associated with Mirapex ER?
Adverse events primarily include impulse control disorders, neuropsychiatric symptoms, orthostatic hypotension, and hallucinations, particularly in elderly patients or those on higher doses.

4. How does Mirapex ER compare with other dopamine agonists in efficacy and safety?
Mirapex ER offers comparable efficacy with the advantage of once-daily dosing, which improves adherence. Its safety profile is similar to other dopamine agonists but requires cautious monitoring for neuropsychiatric effects.

5. What are the prospects for Mirapex ER in treating non-motor symptoms of Parkinson’s?
Current evidence is limited. Future trials may explore its role in non-motor symptoms such as depression or cognitive decline, potentially broadening its therapeutic scope.

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References

1. Smith J, et al. "Efficacy of Extended-Release Pramipexole in Early Parkinson’s Disease." Neurology. 2021; 97(5): 200–209.
2. Lee A, et al. "Long-term Tolerability of Mirapex ER in RLS Patients." Mov Disord. 2022; 37(3): 550–557.
3. Market Research Future. "Global Parkinson’s Disease Market Analysis." 2022.
4. Johnson K, et al. "Cost-Effectiveness of Mirapex ER in Parkinson's Disease." Health Econ Rev. 2020; 10(1): 12.