EUCTR2009-012897-12-RO进行中（未招募）不适用
A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor
BIAL-Portela & Ca, SA0 个研究点目标入组 32 人开始时间: 2015年3月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •At screening (admission to the baseline period):
- •- Male or female of non-childbearing potential (by reason of surgery or postmenopausal);
- •- Age = 30 years;
- •- A diagnosis of PD according to the UK PDS Brain Bank diagnostic criteria (bradykinesia and at least one of the
- •following: muscular rigidity, rest tremor and postural instability);
- •- Predictable signs of end-of-dose deterioration despite optimal” levodopa/carbidopa or levodopa/benserazide
- •- Modified Hoehn and Yahr stage of less than 5 in the off” state; mean duration of off” state =1.5 h during
- •waking hours (based on historical information);
- •- Results of clinical laboratory tests acceptable by the investigator (not clinically significant for the well-being of
- •the patient or for the purpose of the study);
- •- Able and willing to give written informed consent.
- •At randomisation (completion of the baseline period):
- •- Been treated with a stable regimen of 3 to 8 doses per day of standard-release levodopa/carbidopa 100/25 mg
- •(Sinemet®) or levodopa/benserazide 100/25 mg (Madopar®/Restex®) for at least 1 week prior to randomisation;
- •- Mean duration of off” state =1.5 h during waking hours (average of recordings of last 3 evaluable days on
- •patient’s diary);
- •- Concomitant anti-Parkinsonian medication (other than apomorphine, entacapone or tolcapone) in stable doses
- •for at least 4 weeks prior to admission;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At screening (admission to the baseline period):
- •- Non-idiopathic parkinsonism (atypical parkinsonism, symptomatic parkinsonism, Parkinson-plus syndrome);
- •- Treated with entacapone, tolcapone, neuroleptics, antidepressants (except serotonin-specific reuptake inhibitors
- •or imipraminics [desipramine, imipramine, clomipramine and amitriptyline]), monoamine oxidase inhibitors
- •(except selegiline up to 10 mg/day in oral formulation or 1.25 mg/day in buccal absorption formulation or
- •rasagiline up to 1 mg/day) or antiemetics (except domperidone) within 2 weeks prior to admission;
- •- Treated with any investigational product within 1 month prior to admission (or within 5 half-lives, whichever is
- •- A psychiatric or any medical condition that might place him/her at increased risk or interfere with assessments;
- •- Known hypersensitivity to any of the ingredients of the investigational products;
- •- A history of abuse of alcohol, drugs or medications within the last 2 years;
- •- A clinically relevant ECG abnormality;
- •- A history or current evidence of heart disease, including but not limited to myocardial infarction, angina,
- •congestive heart failure and cardiac arrhythmia;
- •- Unstable concomitant disease being treated with changing doses of medication;
- •- A history or current evidence of any relevant disease in the context of this study, i.e., with respect to the safety
- •of the patient (e.g., hepatic impairment) or related to the study conditions;
- •- A test positive for the HIV-1 or HIV-2 antibodies, or hepatitis B surface antigen (HbsAg), or hepatitis C
- •antibody (HCVAb);
- •- Donated blood or received blood or blood products within the 6 months prior to admission;
- •- Pregnant, breast-feeding or of childbearing potential;
- •- Other condition or circumstance that, in the opinion of the investigator, may
- •compromise the patient’s ability to comply with the study protocol.
- •At randomisation (completion of the baseline period):
- •- Treated with levodopa/DDCI in a 10:1 ratio or in a controlled-release formulation during the baseline period;
- •- Treated with apomorphine during the baseline period;
- •- A clinically relevant ECG abnormality.
研究者
相似试验
进行中（未招募）
1 期
A double-blind, randomised, placebo-controlled study to evaluate topical 10%phenylephrine gel applied peri-anally in the management of ileal pouch anal anastomosis (IPAA)-related faecal incontinence - A study to Evaluate 10% Phenylephrine Gel in the Management of Faecal IncontinenceIleal pouch anal anastomosis (IPAA)-related faecal incontinenceMedDRA version: 14.1Level: PTClassification code 10016092Term: Faecal incontinenceSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2006-002739-25-GBS.L.A. Pharma (UK) Ltd100
尚未招募
3 期
A double-blind, randomised, placebo-controlled study to evaluate the effect of Testofen, a specialized extract of Trigonella foenum-graecum (Fenugreek) seed on sexual function and quality of life (QOL) in healthy females.Female sexual function, energy and staminaMetabolic and Endocrine - Normal metabolism and endocrine development and functionAlternative and Complementary Medicine - Herbal remediesACTRN12611001031954AZPA International80
已完成
不适用
A double-blind, randomised, placebo-controlled study to evaluate the effect of an orally-dosed herbal formulation containing Testofen, on sexual function, performance, and serum testosterone levels in healthy males.Sexual performanceSexual functionAlternative and Complementary Medicine - Herbal remediesMetabolic and Endocrine - Other metabolic disordersACTRN12611000830998AZPA International60
招募中
3 期
A double-blind, randomised, placebo-controlled study to evaluate the effectiveness of an orally dosed supplement, Skin Accumax, containing vitamin A, vitamin E, vitamin C, phosphatidylcholine (lecithin) and diindolylmethane, on treating acne in men and women aged between 16 and 35.AcneACTRN12614000008628Integrated Health Group Pty. Ltd.80
招募中
4 期
Effect of Iron Repletion in Symptomatic Patients with Atrial Fibrillation (IRON-AF)Iron deficiencyCardiovascular - Other cardiovascular diseasesAtrial fibrillationACTRN12620000285954niversity of Adelaide84