Effect of Safinamide on Pain in Idiopathic Parkinsons Disease A Randomized Double blind Placebo Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The difference in change of pain scores at 12 weeks using the Kings Parkinsons disease Pain Scale between patients with IPD using safinamide and placebo
研究概览
简要总结
Other than the optimization of anti-parkinsonian treatment, additional pain treatment strategies are needed to properly address pain management in PD. There are no placebo controlled RCTs with Safinamide on pain in Idiopathic Parkinson’s disease (IPD) patients. Despite its significance the various mechanisms of underlying pain in PD is often poorly understood and therapeutic management is a challenge. So, there is a need to conduct studies on the effects of safinamide on pain in IPD patients. Study will be started after obtaining Institute ethics committee approval. Patients who satisfy the eligibility criteria will be enrolled in the study. The patient will be provided information about the study and explicit consent will be taken. Once patient is willing to participate, appointment will be fixed as per convenience of the patient. At the beginning of the study KPPS, UPDRS III, PDQ-39, NMSS will be recorded. Patients will be then randomized into the Safinamide or place-bo groups. Safinamide and placebo will be supplied in identical (50 mg) strips taken for two weeks, once daily in the morning. Then safinamide and placebo will be provided in identical (100 mg) strips and continued for further ten weeks. KPPS, UPDRS 3, PDQ-39, NMSS, patient global impression of change (PGI-C) score, and clinical global impression of improvement (CGI-I) score will be re-peated at 6 weeks. After 12 weeks, safinamide and placebo will be tapered to doses of 50 mg and stopped in a week. Subjects will be contacted by telephone once a week to check for adverse effects and compliance. KPPS, UPDRS III, NMSS, PDQ-39, PGI-C, and CGI-I will be repeated at the end of 12 weeks for comparison. Patients and investigators will be unaware of treatment allocation at all times. If any of the study subjects have an exacerbation of pain during the study period and if it is severe, present daily for more than 2 weeks unblinding will be done and they will be treated symptomatically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are diagnosed with IPD(Idiopathic parkinsons disease)
- •Patients with IPD with age 30 years and above with a minimum KPPS score greater than and equal to 4 as well as moderate pain in one of the seven subdomains of the KPSS.
- •Pain must be related to PD and not explained by any other health problem, like Eg: peripheral neuropathy, organ disease, pain related to arthritis etc.
- •Patients can be included if the intensity of these PD unrelated pains are aggravated by PD.
- •Receiving treatment with a stable dose of oral levodopa which includes controlled release, immediate release or a combination of controlled release and immediate release medication or dopamine agonists for at least 4 weeks before randomization.
排除标准
- •Patients with other types of parkinsonism, atypical and drug induced.
- •Patients with a diagnosis of or those meeting DSM-V criteria for major depression disorder, Schizophrenia, Bipolar disorder, Substance abuse disorder, other psychotic disorder which requires treatment with anti-psychotic medication.
- •Patients with history of dementia, and cognitive dysfunction
- •Known chronic headache disorder such as chronic migraine more than 15 days a month or cancer related pain.
- •Ophthalmologic diseases like severe hypertensive diabetic/hypertensive retinopathy, inherited or familial retinopathies.
- •Patients with child-pugh score moderate or severe liver failure
- •Contraindications, drug allergy/sensitivity, or intolerance to safinamide.
结局指标
主要结局
The difference in change of pain scores at 12 weeks using the Kings Parkinsons disease Pain Scale between patients with IPD using safinamide and placebo
时间窗: baseline and 12 weeks
次要结局
- The difference in change of pain scores using the KPPS at 6 weeks between patients with Idiopathic Parkinsons disease using Safinamide and placebo(baseline and 6 weeks)
- The difference in change of scores in quality of life using Parkinsons disease quality of life questionnaire (PDQ-39) between patients with IPD using Safinamide and placebo.(baseline, 6 weeks and 12 weeks)
- The difference in change of scores of Non-motor symptoms using Non motor symptoms scale [NMSS] between patients with IPD using Safinamide and placebo.(baseline, 6 weeks and 12 weeks)
- The difference in change of scores in motor symptoms using Unified Parkinson disease rating scale- UPDRS III between patients with IPD using Safinamide and placebo(baseline, 6 weeks and 12 weeks)
- The difference in change of scores of patient global impression of change (PGI-C) between patients with IPD using Safinamide and placebo.(baseline, 6 weeks and 12 weeks)
- The difference in change of scores of clinical global impression of improvement (CGI-I) between patients with IPD using Safinamide and placebo.(baseline, 6 weeks and 12 weeks)