Autism, Pediatric Autism
Conditions
Keywords
Namenda, Autism, Memantine, Pediatric, Forest Laboratories
Brief summary
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.
Detailed description
This is a 48-week multicenter extension study comprised of a 6-week double-blind dose-titration period followed by a 42-week open-label maintenance period. In the Forest autism trials conducted in children ages 6-12, dosing with an extended release formulation of memantine was weight-based. These weight based dose limits were selected to ensure exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng∙h/mL that represented a 10-fold lower exposure than observed at the NOAEL (No observed adverse effect level) of 15 mg/kg/day in juvenile rats. The weight-based dose limits in these studies were as follows: * Group A: ≥ 60 kg; max 15 mg/day * Group B: 40-59 kg; max 9 mg/day * Group C: 20-39 kg; max 6 mg/day * Group D: \< 20 kg; max 3 mg/day
Interventions
DRUGMemantine HCl
Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.
Sponsors
Merz Pharmaceuticals GmbH
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Completed lead-in study MEM-MD-57A (NCT00872898) * A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
Exclusion criteria
* Patients with a concurrent medical condition that might interfere with the conduct of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) | From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48) | Number of patients who experienced one or more TEAEs during the study |
Countries
United States
Participant flow
Recruitment details
Patients who completed the lead-in study MEM-MD-57A (NCT00872898) were eligible to enroll in this study. A total of 19 study centers in the United States enrolled patients.
Pre-assignment details
Patients receiving placebo in the lead-in study underwent a double-blind up-titration targeting same weight-based dose assigned at lead-in study. Patients receiving a stable dose of active were not re-titrated but double-blind was maintained. Patients who were not dosed for more than 3 days between the studies underwent an open-label titration.
Participants by arm
| Arm | Count |
|---|---|
| Memantine Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Inclusion/exclusion criteria not met | 1 |
| Overall Study | Lack of Efficacy | 5 |
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Other Reason | 3 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Memantine |
|---|---|
| Age, Continuous Years | 9.1 years STANDARD_DEVIATION 2.2 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants |
| Race/Ethnicity, Customized Asian | 9 participants |
| Race/Ethnicity, Customized Black | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 participants |
| Race/Ethnicity, Customized Non-Hispanic or Latino | 91 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White | 86 participants |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 37 / 50 | 37 / 52 |
| serious Total, serious adverse events | 1 / 50 | 0 / 52 |
Outcome results
Primary
Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
Number of patients who experienced one or more TEAEs during the study
Time frame: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)
Population: The Safety Population consists of 102 enrolled patients who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Memantine | Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) | 85 participants |