CLINICAL TRIALS PROFILE FOR REQUIP XL

505(b)(2) Clinical Trials for REQUIP XL

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	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.
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.

All Clinical Trials for REQUIP XL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00260793 ↗	Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease	Unknown status	Colorado Neurology	Phase 3	2005-11-01	The purpose of this research study is to see if subjects with Parkinson's disease who are experiencing motor fluctuations ("on" and "off" states) and dyskinesias (involuntary excessive movements) would benefit from a higher dose of Requip as compared to the maximum FDA approved dose of dopamine agonist drugs (including Requip, Mirapex, and Permax). Requip as used in this study is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) at this dose level.
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.
NCT00144300 ↗	Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients	Completed	Boehringer Ingelheim	Phase 4	2005-01-01	To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.
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.
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.
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.

Clinical Trial Conditions for REQUIP XL

Condition Name

Condition Name for REQUIP XL
Intervention	Trials
Parkinson Disease	13
Parkinson's Disease	11
Healthy	4
Dyskinesias	3

Condition MeSH

Condition MeSH for REQUIP XL
Intervention	Trials
Parkinson Disease	21
Restless Legs Syndrome	5
Psychomotor Agitation	3
Dyskinesias	3

Clinical Trial Locations for REQUIP XL

Trials by Country

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−

Trials by Country for REQUIP XL
Location	Trials
United States	92
China	16
Italy	12
United Kingdom	8
Germany	7

Trials by US State

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−

Trials by US State for REQUIP XL
Location	Trials
Texas	7
Maryland	7
Georgia	6
New York	5
Florida	5

Clinical Trial Progress for REQUIP XL

Clinical Trial Phase

Clinical Trial Phase for REQUIP XL
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	8
Phase 2	7

Clinical Trial Status

Clinical Trial Status for REQUIP XL
Clinical Trial Phase	Trials
Completed	29
Unknown status	4
Terminated	2

Clinical Trial Sponsors for REQUIP XL

Sponsor Name

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

Sponsor Type

Sponsor Type for REQUIP XL
Sponsor	Trials
Industry	27
Other	13
NIH	4

REQUIP XL: Clinical Trials, Market Analysis, and Projections

Introduction

REQUIP XL, an extended-release formulation of ropinirole hydrochloride, is a medication primarily used to treat Parkinson’s disease. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Patient Enrollment and Study Design

Clinical trials for REQUIP XL involved several hundred patients with both early and advanced Parkinson’s disease. For instance, in one advanced Parkinson’s disease trial, 202 patients received REQUIP XL, while 191 patients received a placebo[1][4].

Adverse Reactions

Key adverse reactions observed in these trials include somnolence, sudden onset of sleep, dyskinesia, nausea, and orthostatic hypotension. In the advanced Parkinson’s disease trial, somnolence was reported in 7% of patients on REQUIP XL compared to 4% on placebo. Sudden onset of sleep was reported in 4% to 5% of patients on REQUIP XL across different trials[1][4].

Efficacy

The clinical efficacy of REQUIP XL was evaluated in several phase III studies. These studies showed that REQUIP XL demonstrated non-inferiority to the immediate-release formulation of ropinirole in terms of motor score improvements. For example, in one study, the mean change in UPDRS total motor score for REQUIP XL was -0.1 compared to 0.6 for the immediate-release formulation, which fell within the predefined margin for non-inferiority[3].

Long-Term Safety and Efficacy

There is a lack of long-term studies specifically focusing on the safety and efficacy of REQUIP XL. However, the available data suggest that the adverse event profile persists into the maintenance phase, with events such as constipation, hallucination, and sleep disorders being reported[1][3].

Market Analysis

Market Growth

The Parkinson’s disease market, which includes REQUIP XL, is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.8% from 2020 to 2034. This growth is driven by increasing prevalence of Parkinson’s disease and advancements in treatment options[5].

Generic Availability

REQUIP XL, originally developed by GlaxoSmithKline, has seen the introduction of generic versions. Several manufacturers, including Chartwell Rx and Zydus Lifesciences, have received FDA approval for their generic ropinirole hydrochloride extended-release tablets. This has increased competition and potentially reduced costs for patients[2][5].

Cost-Effectiveness

The cost-effectiveness of REQUIP XL is a significant factor in its market positioning. Studies have compared the costs of treatment strategies involving REQUIP XL with other dopamine agonists like pramipexole and rotigotine. The model assumes an initial six months of treatment with the immediate-release formulation of ropinirole followed by a switch to REQUIP XL, which can impact the overall cost of treatment[3].

Market Projections

Competitive Landscape

The market for Parkinson’s disease treatments is highly competitive, with several dopamine agonists available. REQUIP XL competes with other extended-release formulations like rotigotine and pramipexole. The introduction of generic versions of REQUIP XL is expected to further intensify competition and potentially reduce market share for the brand name product[2][5].

Patient Preferences and Compliance

Patient compliance is a crucial factor in the success of any medication. The extended-release formulation of REQUIP XL offers the convenience of once-daily dosing, which can improve adherence compared to multiple daily doses required with immediate-release formulations[3].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of pharmaceuticals. REQUIP XL has been approved by the FDA in various strengths, and any changes in regulatory policies or the approval of new treatments could impact its market position[2][4].

Key Takeaways

• Clinical Efficacy: REQUIP XL has demonstrated non-inferiority to its immediate-release counterpart in clinical trials.
• Adverse Reactions: Common adverse reactions include somnolence, sudden onset of sleep, and orthostatic hypotension.
• Market Growth: The Parkinson’s disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034.
• Generic Availability: Generic versions of REQUIP XL are available, increasing competition and potentially reducing costs.
• Cost-Effectiveness: Treatment strategies involving REQUIP XL need to be evaluated for cost-effectiveness against other dopamine agonists.

FAQs

What is REQUIP XL used for?

REQUIP XL is used to treat Parkinson’s disease, particularly in patients with early and advanced stages of the condition.

What are the common adverse reactions associated with REQUIP XL?

Common adverse reactions include somnolence, sudden onset of sleep, dyskinesia, nausea, and orthostatic hypotension.

Is REQUIP XL available in generic form?

Yes, generic versions of REQUIP XL are available from several manufacturers.

How does REQUIP XL compare to other dopamine agonists in terms of efficacy?

REQUIP XL has demonstrated non-inferiority to its immediate-release counterpart and other dopamine agonists like pramipexole and rotigotine in clinical trials.

What is the expected market growth for Parkinson’s disease treatments?

The Parkinson’s disease market is expected to grow at a CAGR of 5.8% from 2020 to 2034.

Sources

1. FDA Label for REQUIP XL: AccessData FDA.
2. Generic Requip XL Availability: Drugs.com.
3. Final Appraisal Report - All Wales Therapeutics and Toxicology Centre: NHS Wales.
4. Requip-XL: Package Insert / Prescribing Information: Drugs.com.
5. Ropinirole hydrochloride - Generic Drug Details: DrugPatentWatch.