An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients with Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- Conditions
- Autism or Asperger's Disorder or Pervasive Developmental Disorder NotOtherwise Specified (PDD-NOS) Previously Treated with MemantineMedDRA version: 14.1Level: LLTClassification code 10008520Term: Childhood autismSystem Organ Class: 100000004852MedDRA version: 14.1Level: PTClassification code 10003484Term: Asperger's disorderSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 14.1Level: LLTClassification code 10034739Term: Pervasive developmental disorder NOSSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2012-001630-33-IT
- Lead Sponsor
- FOREST RESEARCH INSTITUTE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
1. The parents/guardian/LAR must provide written informed consent before the patient's participation in the study.2. Parents who are capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. 3. Patients who completed Study 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. 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 Italian sufficiently, as well as have parents who are able to speak and understand Italian sufficiently 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: 110
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
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 being 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 C-SSRS (Columbia-Suicide Severity Rating Scale) 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 prohibited concomitant medications 7. Patients who, in the opinion of the Investigator, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of memantine in the<br>treatment of pediatric patients with autism, Asperger's Disorder or<br>Pervasive Developmental Disorder Not Otherwise Specified<br>(PDD-NOS).;Secondary Objective: Not Applicable - no secondary objectives;Primary end point(s): Standard safety assessments are being conducted to align withthe main<br>objectives of the study stated above. exploratory efficacy assessment<br>evaluation.;Timepoint(s) of evaluation of this end point: Safety assessments are evaluated at:<br>Visit 1 (End of Week 0)<br>Visit 4 (End of Week 6)<br>Visit 5 (End of Week 12)<br>Visit 6 (End of Week 24)<br>Visit 7 (End of Week 36)<br>Visit 8/Early Termination (End of Week 48)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Exploratory efficacy assessment evaluation;Timepoint(s) of evaluation of this end point: Exploratory Efficacy assessments are evaluated at:<br>Visit 1 (End of Week 0)<br>Visit 4 (End of Week 6)<br>Visit 5 (End of Week 12)<br>Visit 6 (End of Week 24)<br>Visit 7 (End of Week 36)<br>Visit 8/Early Termination (End of Week 48)