CLINICAL TRIALS PROFILE FOR MIRAPEX

All Clinical Trials for MIRAPEX

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.

Clinical Trial Conditions for MIRAPEX

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for MIRAPEX

Trials by Country

Trials by Country for MIRAPEX
Location	Trials
United States	173
Canada	9
Spain	4
Italy	3
Germany	3

Trials by US State

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

Clinical Trial Progress for MIRAPEX

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for MIRAPEX
Clinical Trial Phase	Trials
Completed	25
Unknown status	4
Not yet recruiting	1

Clinical Trial Sponsors for MIRAPEX

Sponsor Name

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

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for Mirapex (Pramipexole)

Last updated: October 30, 2025

Introduction

Mirapex (pramipexole), developed by Boehringer Ingelheim and approved by the U.S. Food and Drug Administration (FDA) in 1997, is a dopamine agonist primarily indicated for Parkinson's disease and Restless Legs Syndrome (RLS). Over the past decade, evolving clinical insights, regulatory changes, and market dynamics have shaped its trajectory. This report offers an in-depth update on ongoing clinical trials, a comprehensive market analysis, and future market projections for Mirapex, providing business professionals with strategic insights into its current and future landscape.

Clinical Trials Update

Current Clinical Trial Landscape

As of 2023, Mirapex's clinical development landscape has transitioned from novel efficacy explorations to comparative effectiveness and safety evaluations. No new pivotal trials specifically investigating Mirapex in its primary approved indications are currently recruiting or ongoing. Most recent studies focus on addressing long-term safety, off-label uses, and combinatorial approaches.

Ongoing and Recent Trials

While direct trials involving Mirapex have waned, several related studies provide insights into its broader utility:

• Long-term Safety Studies: Multiple observational cohorts examine the chronic administration of pramipexole, emphasizing neuropsychiatric side effects, impulse-control disorders, and potential associations with pathologic gambling or hypersexuality. These studies aim to refine dosing guidelines and manage adverse events [1].

• Combination Therapy Trials: Several trials investigate combining pramipexole with other PD medications to optimize symptom control and minimize side effects, such as levodopa-induced dyskinesia [2].

• New Indications: A few exploratory studies assess pramipexole's potential in conditions like depression and bipolar disorder, driven by its dopaminergic activity. However, these remain early-phase with limited enrollment and data [3].

Regulatory and Safety Monitoring

The FDA and EMA continue to monitor post-market safety data for Mirapex, especially concerning impulse-control disorders (ICDs), which have garnered increased attention following real-world reports. As of 2022, regulatory agencies have issued updated risk communication emphasizing vigilance for neuropsychiatric adverse effects [4].

Research Challenges and Future Outlook

The absence of recently initiated large-scale trials signals a shift of focus from Mirapex-specific research to newer therapeutics. Challenges in safety profiles, including compulsive behaviors, pose hurdles for expanding indications. Nonetheless, precision medicine approaches examining genetic predictors of adverse effects could revitalize research interest in dopaminergic agents like Mirapex.

Market Analysis

Current Market Landscape

Market Size and Revenue

Mirapex's sales peaked around 2008, with revenues exceeding $1 billion globally [5]. Since then, sales have declined cumulatively due to several factors:

• The advent of newer agents, notably rotigotine and dopamine receptor antagonists with improved side-effect profiles.
• Patent expirations and generic entry introduced lower-cost alternatives.
• The migration of patients to levodopa-centric therapies and non-pharmacologic interventions.

Despite decline, Mirapex remains a significant contributor within the Parkinson’s therapy segment, especially in regions with limited access to newer drugs.

Competitive Landscape

The market for Parkinson's disease has become increasingly fragmented:

• Generic Dopamine Agonists: Pramipexole generics dominate sales in multiple jurisdictions, offering price competition.
• Innovative Therapies: Deep Brain Stimulation, gene therapies, and novel agents (e.g., safinamide, opicapone) are capturing market share, particularly in advanced PD.

For RLS, Mirapex maintains a niche, but drugs like ropinirole and gabapentinoids enjoy comparable or superior efficacy with fewer neuropsychiatric side effects.

Market Drivers

• Growing Prevalence: Parkinson’s disease affects approximately 1% of individuals over 60, with prevalence increasing globally due to aging populations [6].
• Off-Label Uses: Increasing off-label prescriptions for neuropsychiatric conditions sustain demand.
• Patient Preference: Oral formulations with established efficacy and safety profiles support ongoing use among certain patient demographics.

Market Challenges

• Side Effect Profile: Neuropsychiatric adverse effects, including ICDs, necessitate cautious prescribing.
• Patent and Pricing Pressures: Patent expiries and generic competition have suppressed prices.
• Emerging Therapies: Advances in disease-modifying treatments threaten the growth of symptomatic dopaminergic therapies.

Market Projection (2023–2030)

Forecast Assumptions

• Continued patent expiration and generic proliferation will remain a key market factor.
• No significant new indications or pivotal trial approvals for Mirapex are anticipated within the forecast window.
• Market shifts favoring newer, safer agents may accelerate Mirapex’s market share decline.

Projection Summary

Year	Market Share (Estimated)	Revenue (USD billion)	Key Drivers/Constraints
2023	~2-3%	~$0.1 billion	Mature generic landscape; ongoing safety concerns
2025	~1-2%	~$0.05 billion	Competition from newer agents; declining brand relevance
2030	<1%	<$0.02 billion	Market consolidation; potential niche use cases

While Mirapex continues to serve certain patient populations, its role is expected to diminish steadily, with significant part of the market captured by generics and emerging therapies.

Strategic Implications

• Lifecycle Management: Boehringer Ingelheim may focus on developing formulations with improved safety profiles or exploring neuropathological biomarkers to identify optimal patient subsets.
• Off-Label Opportunities: Strategic engagement in off-label indications should be approached cautiously, given regulatory and safety considerations.
• Market Diversification: Expanding into niche treatments for neuropsychiatric conditions under clinical research phases could offer future growth avenues.

Key Takeaways

• Clinical trials involving Mirapex have shifted focus toward safety and combination therapies, with limited innovation concerning new indications. The drug’s safety profile, particularly regarding impulse-control disorders, remains under active surveillance, influencing prescribing practices.
• Market dynamics are characterized by patent expirations and increasing competition from generics and newer agents. These factors have suppressed revenues, with projections indicating further decline over the next decade.
• The future of Mirapex relies heavily on niche applications and personalized medicine approaches. Without significant clinical breakthroughs or new indications, its role will primarily be in established, long-term symptom management.
• Regulatory developments continue to emphasize safety, particularly neuropsychiatric adverse effects, which influence market acceptance and prescribing behaviors.
• Pharmaceutical companies should monitor emerging therapies in Parkinson’s and RLS landscape, as they could rapidly displace established agents like Mirapex.

FAQs

1. Will Mirapex regain market dominance in Parkinson's disease treatment?
Unlikely. The aggressive emergence of newer therapies with improved safety profiles, along with patent expirations and generics, diminish Mirapex’s market share. Its role will remain primarily for long-term management in select populations.

2. Are there ongoing efforts to expand Mirapex’s indications?
Currently, no large-scale trials are underway for new indications. Research focus has shifted toward safety optimization and combinatory regimens within existing approved uses.

3. How do safety concerns influence Mirapex prescribing?
Neuropsychiatric adverse effects, especially impulse-control disorders, prompt cautious use. Regulatory agencies advise regular patient monitoring, which can limit widespread adoption, especially in vulnerable populations.

4. Could personalized medicine revive Mirapex’s prospects?
Potentially. If genetic or biomarker-driven approaches identify patient subsets with reduced risks, Mirapex’s utility could be repositioned, but such strategies are in early exploratory stages.

5. How does market competition impact future sales of Mirapex?
Competition from newer dopamine agonists, atypical therapies, and non-pharmacologic options will likely continue suppressing Mirapex’s sales, relegating it to a niche or secondary role in therapeutic algorithms.

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Sources:
[1] FDA Adverse Event Reporting System, 2022.
[2] ClinicalTrials.gov, ongoing trials involving dopamine agonists, 2023.
[3] Journal of Affective Disorders, exploratory studies on dopaminergic agents, 2022.
[4] EMA Safety Communication, 2022.
[5] IQVIA Sales Data, 2012–2021.
[6] Parkinson’s Foundation, Epidemiology Reports, 2021.