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临床试验/EUCTR2015-003512-20-PL
EUCTR2015-003512-20-PL进行中（未招募）1 期

A Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients

Intec Pharma, Ltd.0 个研究点目标入组 420 人开始时间: 2016年4月1日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
420
研究概览入排标准研究者记录与标识符相似试验

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

  • •General Study Inclusion Criteria:
  • •1. Subjects must be approved for suitability by an Enrollment Approval Committee that is assembled of PD clinical experts
  • •2. Able and willing to give written (signed and dated) informed consent, which includes compliance with study requirements and restrictions prior to admission to the study and adhere to visit schedule and available to complete the study
  • •3. Men or women 30 years of age and higher at initial screening assessment. For the 100 subjects who enter the Gastroscopy sub-study, the age limits are 30-80 years of age, inclusive, at initial screening assessment.
  • •4. Diagnosed with Parkinson's disease, consistent with UK brain bank criteria
  • •5. Has a good response to levodopa and is taking at least 4 doses of a levodopa containing medication (or 3 doses of Rytary) per day during waking hours (not including nighttime long acting levodopa) at a stable dose for at least 28 days prior to initial screening assessment
  • •6. Other Anti-PD treatment (such as dopamine agonists, selective MAOB inhibitors, anticholinergic agents or amantadine) are permitted if stable for at least 28 days prior to study entry and provided they are not anticipated to be changed during the course of the study
  • •7. Total LD immediate release daily dose of 400mg to 1300 mg or equivalent prior to initial screening assessment. Specifically, for Rytary, doses up to 1755 mg daily are acceptable
  • •8. Able to complete a Hauser Home Diary and can tell the difference between On and Off time
  • •a. Achieved at least 75% diary concordance with an approved site rater in a 4-hour training session including at least one Off time assessment
  • •b. Returned a valid 2-day practice diary after training has been completed. A valid diary record will not have more than 4 invalid entries (i.e. double or missed entries)
  • •9. At least 2.5 hours Off time per day during waking hours on Screening 2-Day practice Hauser Home Diary, (morning akinesia should be incorporated into the total Off time assessment)
  • •10. Other than PD, the subject is in satisfactory health, as assessed by physical examination and screening tests. No clinically significant medical, psychiatric or laboratory abnormality that could compromise safety or interfere with study procedures in the opinion of either the investigator or the Enrollment Approval Committee/Sponsor.
  • •11. Living in an area that is within 3 hours driving distance from the study site or is willing to stay in such a place the night before each study visit.
  • •Gastroscopy sub-study inclusion criteria:
  • •Subjects entering the study in the period when gastroscopy examinations are required will have to comply with the following additional requirements:
  • •1. Men or women between 30 and 80 years of age, inclusive, at initial screening assessment
  • •2. Willingness to undergo two gastroscopies during the study period and to sign a separate informed consent form
  • •3. No contraindications for sedation / anesthesia
  • •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 189
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 231

排除标准

  • •General Study
  • •1. Participation in another drug clinical trial within 28 days prior to initial screening assessment (calculated from the previous study's last dosing date)
  • •2. Atypical Parkinsonism (subjects with Parkinsonian features caused by disorder such as multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies or multiple brain infarcts)
  • •3. Clinically significant cardiac, pulmonary, hepatic or renal disease or other condition which contraindicates his/her participation in the opinion of either the investigator or the Enrollment Approval Committee/Sponsor.
  • •4. Severe dyskinesia in the opinion of either the investigator or the Enrollment Approval Committee
  • •5. Treatment with non-selective monoamine oxidase (MAO) inhibitors during the last 28 days prior to initial screening assessment or planning to take during study participation
  • •6. Previous or planned neurosurgical treatment for Parkinson's Disease (e.g., procedures including ablation or deep brain stimulation) during the course of the study
  • •7. Significant cognitive impairment as defined by the Mini-Mental State Examination (MMSE) score <26
  • •8. Clinically significant psychiatric illness, including major depression (Hamilton Depression Rating Scale-17 =14). Subjects with a lifetime history of suicidal attempt (including an active attempt, interrupted attempt or aborted attempt)
  • •9. Current or previous treatment for more than 28 days within the past 2 years with any neuroleptic drug (antipsychotic) or any other drug with anti-dopaminergic properties (e.g. metoclopramide, domperidone).
  • •10. Currently experiencing or any known history of psychosis or delusions within 2 years prior to Screening.
  • •11. Known history of substance abuse within the past 2 years
  • •12. Moderate or greater level of alcohol consumption
  • •13. Unable to swallow large pills (e.g., large vitamin pills)
  • •14. History of Melanoma or suspicious skin lesion which could be a Melanoma
  • •15. Narrow-angle Glaucoma
  • •16. History of small bowel or gastric surgery (Including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, or frequent nausea or emesis, regardless of etiology. (Previous appendectomy or hernioplasty will not be exclusionary.
  • •17. Active peptic ulcer disease or a history of peptic ulcer or upper GI bleeding
  • •18. Regular use of opioids (Intermittent opioid use is not exclusionary)
  • •19. Symptomatic gastroparesis with frequent vomiting (at least once a week)
  • •20. Concomitant use of NSAIDs and oral steroids within the past 28 days
  • •21. Allergy to the study drug or any of its excipients, or to Yellow Dye #5 (tartrazine)
  • •22. Women who are pregnant or nursing. Women of childbearing potential who are not willing to use a medically acceptable method of contraception. Medically acceptable methods of contraception that may
  • •be used by the subject and /or partner include: True abstinence when this is in line with the preferred and usual lifestyle of the subject, oral contraceptive agents, intrauterine devices (IUDs), implantable contraceptives (e.g., Norplant), transdermal hormonal contraceptives (e.g., Ortho-Evra), and injectable contraceptives (e.g., Depo-Provera),
  • •condom and /or diaphragm, diaphragm with vaginal spermicide, surgical sterilization (6 months), or postmenopausal females ( no menstrual period for > 2years) or vasectomy ( > 6 months). The current contraceptive therapy must be maintained thr

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