EUCTR2012-001630-33-BE进行中（未招募）1 期
An Open-Label Extension Study of the Safety and Tolerability of Memantinein Pediatric Patients with Autism, Asperger’s Disorder or PervasiveDevelopmental Disorder Not Otherwise Specified (PDD-NOS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- •To be eligible to participate in the study, patients must meet the following criteria:
- •1. Provide written informed assent, when developmentally appropriate, to participate in
- •the study before conduct of any study-specific procedures. The parent/guardian/LAR
- •must provide written informed consent for the patient’s participation in the study. A
- •separate written informed consent for the caregiver must also be obtained before the
- •conduct of any study-specific procedures
- •2. Have a knowledgeable caregiver who is capable of providing reliable information
- •about the patient’s condition, attending all clinic visits with the patient, and
- •overseeing the administration of investigational product. Every effort should be made
- •to maintain the same caregiver as used in the preceding study throughout this study
- •3. Patients who completed Study MEM-MD-67, MEM-MD-68 or MEM-MD-91.
- •Patients who discontinued Study MEM-MD-68 due to meeting the criterion for loss
- •of therapeutic response. Sponsor approval is required before enrolling any other
- •patient who discontinued a preceding memantine study
- •4. Females who are 9 years and older or who have had onset of menses must have a
- •negative urine pregnancy test at Visit 1
- •5. Have normal results from a physical examination and laboratory tests at Visit 1 of this
- •study (last visit of the preceding study). Any abnormal findings must be deemed not
- •clinically significant by the Investigator and documented
- •6. Have a family that is sufficiently organized and stable to guarantee adequate safety
- •monitoring and continuous attendance to clinic visits for the duration of the study
- •7. Be able to speak and understand English sufficiently (or their native language if this
- •can be accommodated by the site), as well as have a caregiver and
- •parent/guardian/LAR who is able to speak and understand English sufficiently
- •(or their native language if this can be accommodated by the site), to comprehend the
- •nature of the study and to allow for the completion of all study assessments
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 450
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who meet any of the following criteria will not be eligible to participate in the study:
- •1. Patients who discontinued a preceding memantine study due to an adverse event
- •possibly related to study drug
- •2. Patients with a concurrent medical condition that might interfere with the conduct of
- •the study, confound interpretation of the study results, or endanger the patient’s well
- •3. Significant risk of suicidality based on the Investigator’s judgment, ABC-I, or if
- •appropriate, as indicated by a response of yes” to questions 4 or 5 in the suicidal
- •ideation section of the Children’s Columbia-Suicide Severity Rating Scale (C-SSRS)
- •or any suicidal behavior
- •4. Patients with evidence or history of malignancy (other than excised basal cell
- •carcinoma) or any significant hematologic, endocrine, cardiovascular (including any
- •rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease
- •5. Female patients of child-bearing potential who are not using or not willing to use a
- •conventional method of contraception approved by the PI. Abstinence is an
- •acceptable method of contraception
- •6. Patients requiring treatment with disallowed concomitant medications (Appendix III)
- •7. Patients who, in the Investigator’s opinion, might not be suitable for the study
- •8. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of
- •its affiliates or partners, or the study center
研究者
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