Autism or Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine MedDRA version: 14.1 Level: PT Classification code 10003484 Term: Asperger's disorder System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: LLT Classification code 10008520 Term: Childhood autism System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: LLT Classification code 10034739 Term: Pervasive develop
Conditions
Interventions
Product Name: Memantine Hydrochloride
Product Code: MRZ 2/145
Pharmaceutical Form: Prolonged-release capsule
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
CAS Number: 41100-52-1
Concentration unit: mg
Sponsors
Forest Research Institute, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in the study, patients must meet the following criteria: 1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 2. Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91 (at least a 10 point reduction in SRS total raw score relative to Visit 1 of MEM-MD-91) 3. 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 before 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 4. 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 study drug. Every effort should be made to maintain the same caregiver as used in the lead-in study throughout this study 5. Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented 6. 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 7. 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 8. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1 Are the trial subjects under 18? yes Number of subjects for this age range: 96 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
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be eligible to participate in the study: 1. 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 being 2. 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 C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior 3. 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 4. 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 5. Patients requiring treatment with prohibited concomitant medications 6. Patients who, in the opinion of the Investigator, might not be suitable for the study 7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo in pediatric patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously on stable memantine therapy utilizing a randomized withdrawal paradigm.;Secondary Objective: Not Applicable;Primary end point(s): Standard safety assessments are being conducted to align with the main objective of the study stated in E.2.1. The primary outcome measure in this study will be the proportion of patients meeting the criterion for Loss of Therapeutic Response (LTR). LTR is defined as worsening (increase) of at least 10 points in the SRS total raw score relative to the score at Visit 1 (randomization) of this study.;Timepoint(s) of evaluation of this end point: Visit 2 (End of Week 2) Visit 3 (End of Week 4) Visit 4 (End of Week 6) Visit 5 (End of Week 8) Visit 6 (End of Week 10) Visit 7 (End of Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Children’s Communication Checklist-2 (CCC-2) (Change from baseline in 10 subscales of the CCC–2) ;Timepoint(s) of evaluation of this end point: Visit 4 (End of Week 6) Visit 7 (End of Week 12/Final Visit/Early Termination) | — |
Countries
Australia, Belgium, Colombia, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Ukraine, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Quintiles Contact Center
Outcome results
None listed