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Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR REQUIP


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505(b)(2) Clinical Trials for Requip

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00363727 ↗ Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's Completed GlaxoSmithKline Phase 3 2003-12-01 This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.
New Formulation NCT03250117 ↗ Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole Terminated Titan Pharmaceuticals Phase 1/Phase 2 2017-10-10 Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 3 months of treatment, and evaluate the side effects of this new formulation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Requip

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00108667 ↗ Talampanel to Treat Parkinson's Disease Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2005-04-01 This study will evaluate the effects of the experimental drug talampanel on dyskinesias (involuntary movements) that develop in patients with Parkinson's disease as a result of long-term treatment with levodopa (Sinemet). The drug will be tested alone and in combination with amantadine-a drug commonly used to alleviate dyskinesias. Patients between 21 and 80 years of age with Parkinson's disease and dyskinesias may be eligible for this study. Screening and baseline evaluation. Participants are evaluated with a medical history, physical and neurologic examinations, blood and urine tests, electrocardiogram (EKG) and pregnancy test, if applicable. A chest x-ray and MRI or CT scan of the brain are done if needed. Patients stop taking all antiparkinsonian medications for one month (2 months if taking Selegiline) before the study begins and throughout its duration, except for certain medicines allowed, including Sinemet, Mirapex and Requip. Amantadine can be taken up to 1 week before beginning the study. 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 it 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. At given times during the infusion, saline is given instead of Sinemet. The infusions usually begin in the early morning and continue until evening. Patients resume taking Sinemet between infusions. (Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study.) After the dose-finding phase, patients are randomly assigned to take placebo (a "sugar pill") or talampanel. Those taking talampanel also receive amantadine at their usual dosages. At some point in the study, amantadine is replaced with placebo. Patients in the talampanel group also receive placebo for portions of the study. Active study phase. At study weeks 1, 5 and 7, patients are admitted to the Clinical Center overnight for a levodopa infusion with talampanel or placebo. The day before the infusion, patients have a brief physical examination, blood and urine tests, an EKG, and a review of symptoms or changes in their condition. The next day, they receive an infusion of levodopa at the dose determined in the dose-finding phase. Then they take a pill containing either talampanel or placebo. Their parkinsonian symptoms and dyskinesias are evaluated and videotaped every 30 minutes for about 6 hours. Blood is drawn and an EKG is obtained. At the end of the infusions and ratings, patients resume their regular Parkinson's medications and are given a new supply of study medications to take home. At weeks 2, 3, 4 and 6, patients come to the Clinical Center for a review of drug side effects. They have blood drawn and receive a new supply of study medications that last until the next visit. Follow-up. Two 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Requip

Condition Name

Condition Name for Requip
Intervention Trials
Parkinson Disease 13
Parkinson's Disease 11
Healthy 4
Restless Legs Syndrome 3
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Condition MeSH

Condition MeSH for Requip
Intervention Trials
Parkinson Disease 21
Restless Legs Syndrome 5
Psychomotor Agitation 3
Dyskinesias 3
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Clinical Trial Locations for Requip

Trials by Country

Trials by Country for Requip
Location Trials
United States 92
China 16
Italy 12
United Kingdom 8
Germany 7
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Trials by US State

Trials by US State for Requip
Location Trials
Texas 7
Maryland 7
Georgia 6
New York 5
Florida 5
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Clinical Trial Progress for Requip

Clinical Trial Phase

Clinical Trial Phase for Requip
Clinical Trial Phase Trials
Phase 4 8
Phase 3 8
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Requip
Clinical Trial Phase Trials
Completed 29
Unknown status 4
Terminated 2
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Clinical Trial Sponsors for Requip

Sponsor Name

Sponsor Name for Requip
Sponsor Trials
GlaxoSmithKline 13
National Institute of Neurological Disorders and Stroke (NINDS) 4
Lupin Ltd. 3
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Sponsor Type

Sponsor Type for Requip
Sponsor Trials
Industry 27
Other 13
NIH 4
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Requip (Ropinirole): Clinical Trials, Market Analysis, and Projections

Introduction to Requip (Ropinirole)

Requip, also known by its generic name ropinirole, is a dopamine agonist used primarily for the treatment of Parkinson’s disease and restless legs syndrome (RLS). Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials and Efficacy

Parkinson’s Disease

Clinical trials have demonstrated the efficacy of ropinirole in treating Parkinson’s disease. A 12-month study published in JAMA Neurology showed that patients treated with ropinirole experienced significant improvement in motor function compared to those receiving a placebo. The study used the Unified Parkinson's Disease Rating Scale (UPDRS) to measure motor function and found that fewer patients in the ropinirole group required supplemental levodopa or were withdrawn due to lack of medication efficacy[4].

Restless Legs Syndrome

For RLS, ropinirole is recommended by practice parameters due to its clear benefits outweighing the harms. It is often used alongside other treatments like pramipexole. The discontinuation of certain dosage strengths of ropinirole tablets, however, has not affected its recommendation for RLS treatment[1].

Market Analysis

Current Market Status

The market for restless legs syndrome, where ropinirole is a key player, is expected to grow significantly. By 2025, the RLS market is projected to reach USD 727.58 million and is anticipated to grow at a CAGR of 5.21% to reach USD 937.92 million by 2030[2].

Impact of Discontinuation

In 2019, GlaxoSmithKline announced the discontinuation of all dosage strengths of ropinirole tablets and the 2-mg extended-release tablets due to a business decision. However, this discontinuation does not apply to the 4-mg, 6-mg, 8-mg, and 12-mg tablets of Requip XL. This move could potentially impact the market share of ropinirole but does not eliminate its presence entirely[1].

Regional Market

North America currently holds the largest market share for RLS treatments, while Europe is expected to be the fastest-growing region over the forecast period (2025-2030)[2].

Market Projections

Growth Drivers

The growth of the RLS market, and by extension the demand for ropinirole, is driven by several factors:

  • High Prevalence of RLS: Studies have shown that the prevalence of RLS varies between 3.9% and 14.3% globally, with higher rates among females[2].
  • Association with Diabetes: People with diabetes have an increased risk of developing RLS, and with 37.3 million people in the United States having diabetes, this association is a significant driver of market growth[2].
  • COVID-19 Impact: The COVID-19 pandemic has accelerated the treatment of RLS due to increased sleep disturbances and RLS symptoms in long-COVID-19 patients[2].

Market Size and Revenue

The RLS market, which includes ropinirole, is expected to grow from USD 727.58 million in 2025 to USD 937.92 million by 2030. This growth is attributed to the increasing prevalence of RLS, the high unmet need for treatment, and the rising geriatric population[2].

Competitive Landscape

Key players in the RLS market include UCB S.A, Sun Pharmaceutical Industries Ltd, Boehringer Ingelheim International GmbH, Relegs, and Azurity Pharmaceuticals, LLC. These companies are involved in various initiatives such as product launches, mergers, acquisitions, and partnerships, which are expected to boost market growth[2].

Challenges and Restraints

Side Effects

One of the significant restraints on the market growth is the side effects associated with RLS treatments. Despite the benefits, medications like ropinirole can have adverse effects that may deter some patients from seeking treatment[2].

Key Takeaways

  • Clinical Efficacy: Ropinirole has shown significant efficacy in treating Parkinson’s disease and RLS in clinical trials.
  • Market Growth: The RLS market is projected to grow at a CAGR of 5.21% from 2025 to 2030.
  • Regional Dominance: North America holds the largest market share, while Europe is the fastest-growing region.
  • Growth Drivers: High prevalence of RLS, association with diabetes, and COVID-19 impact are key drivers of market growth.
  • Challenges: Side effects associated with RLS treatments are a significant restraint on market growth.

FAQs

What is the current market size of the Restless Legs Syndrome market?

The Restless Legs Syndrome market size is expected to reach USD 727.58 million in 2025[2].

Why was the discontinuation of ropinirole tablets announced?

The discontinuation of ropinirole tablets was announced due to a business decision made by GlaxoSmithKline[1].

What are the key drivers of the Restless Legs Syndrome market growth?

The key drivers include the high prevalence of RLS, the association with diabetes, and the impact of the COVID-19 pandemic[2].

Which region is expected to grow the fastest in the Restless Legs Syndrome market?

Europe is estimated to grow at the highest CAGR over the forecast period (2025-2030)[2].

What are the side effects associated with restless legs syndrome treatments that could restrain market growth?

Side effects associated with RLS treatments, such as those seen with ropinirole, can deter patients and restrain market growth[2].

Sources

  1. AASM: GSK to discontinue RLS treatment ropinirole, maintain extended release tablets.
  2. Mordor Intelligence: Restless Legs Syndrome Market Size & Share Analysis.
  3. GlobalData: Parkinson's Disease - Global Drug Forecast and Market Analysis to 2029.
  4. JAMA Neurology: Ropinirole for the Treatment of Early Parkinson Disease: A 12-Month Study.
  5. Grand View Research: Parkinson's Disease Treatment Market Size Report, 2030.
Last updated: 2025-01-07

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