An Open-Label Prospective Study of Restless Legs Patients Switched to Ropinirole From Pramipexole to Help Determine the Equipotent Dose
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- CGI-S/CGI-I: (Visits 1, 2, and 4)
研究概览
简要总结
The purpose of this study is to determine the equipotent dose of ropinirole and pramipexole for patients switched from pramipexole to ropinirole in patients with moderate to severe primary Restless Legs Syndrome (RLS). The rationale behind Switch is that patients with Restless Legs Syndrome can maintain stable efficacy and tolerability if correctly switched from one dopamine agonist to an equipotent dose of another.
详细描述
BACKGROUND Dopamine agonists such as ropinirole (Requip) and pramipexole (Mirapex) are effective treatments for Restless Legs Syndrome and Parkinson Disease. However, although the safety and efficacy may be established, it is common for clinicians to switch between therapies in order to seek optimal symptomatic relief for their patients. The best strategy for switching from other dopamine agonists to Requip is currently undetermined. Currently, ropinirole is the only medication indicated for the treatment of moderate to severe RLS.
Every patient will have an individual response to each dopamine agonist. Usually patients are switched from one dopamine agonist to another due to the following factors:
- Lack of response or loss of efficacy
- Predictable and dose-related side effects
- Ergot-associated adverse events (pulmonary fibrosis, cardiac valvulopathy, etc.)
- Sleep events (sudden onset of sleep)
- Peripheral edema
- Patient co-morbidities
The lack of clinical data makes it difficult to recommend switching guidelines that are suitable for all patients. It is therefore recommended that the switching regimen be based on clinical judgment with individualization for each patient. Switching from one dopamine agonist to another is dependent upon a number of factors including:
- The currently prescribed dopamine agonist
- The dose of the current dopamine agonist
- Whether dopamine agonist is being administered as monotherapy or as adjunct therapy to L-dopa
- Individual patient response to both the current agonist and to the other dopamine agonist (efficacy and tolerability)
- Stage of the disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent is obtained
- •Males and/or females; females of childbearing potential, who are not currently pregnant, must agree to use a medically accepted method of contraception throughout the study (i.e., oral contraception, intra- uterine device, or a long-acting injectable form of contraception). Barrier methods alone (i.e., condom) are not adequate.
- •Age > 18 years to ≤ 80 years
- •Patients with moderate to severe primary RLS
- •Stable dose of Pramipexole, between 0.25 mg and 0.75mg, for Restless Legs Syndrome for 4 weeks prior to enrollment
- •IRLS >15 (before pramipexole was initiated)
排除标准
- •Anyone who does not fit the criteria stated under "Inclusion Criteria" and anyone who is included in the following criteria:
- •Currently taking neuroleptic medications
- •Currently taking dopamine blocking anti-emetic medications.
- •Currently taking any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, fluvoxamine) or induce CYP1A2 (e.g., omeprazole) (Note: Subjects already on these agents may be enrolled, but must remain on stable doses of the agents from (Visit 1) 14 days prior to Baseline to the end of the study.
- •Current hallucinations
- •History of disabling hallucinations or hallucinations in past requiring treatment
- •Mini-Mental status examination score < 25 on a scale of 30
- •Orthostatic hypotension >30 systolic drop and >20 diastolic drop
- •On cholinesterase inhibitors or memantine
- •Troublesome edema due to any reason
- •Epworth sleepiness scale >8
- •Another primary sleep disorder (e.g. obstructive sleep apnea, narcolepsy)
- •Secondary causes of RLS (iron deficiency, renal failure)
- •Unstable medical conditions as determined by the investigator
- •Inadequately managed depression (patient on antidepressants must be on stable dose for 4 weeks prior to enrollment)
- •Other stable medical conditions which may interfere with patient evaluation
- •Female who is pregnant or lactating
- •Use of an investigational drug within the last 30 days
结局指标
主要结局
CGI-S/CGI-I: (Visits 1, 2, and 4)
时间窗: 5 min
IRLS: (Visits 1, 2, and 4)
时间窗: 5 min
Epworth Sleepiness Scale: (Visits 1, 2, and 4)
时间窗: 5 min
ECG: An "ECG" or "electrocardiogram" is a test that measures the electrical activity of the heart. (Visits 1, 2, and 4)
时间窗: 5 min
次要结局
未报告次要终点