A Phase 2 interventional study of Memantine Hydrochloride (HCl) in Autism Spectrum Disorder (ASD), Autism and Autistic Disorder, sponsored by Forest Laboratories. Terminated at 106 sites in 16 countries. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2015-02-16.
Sponsored by Forest Laboratories · Phase 2, Interventional, and Treatment
The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
This clinical study was a 48-week, multicenter, multinational, open-label extension study in pediatric outpatients with autism, Asperger's Disorder, or PDD-NOS conducted at 106 study centers. Patients were eligible for this long-term extension study if they had:
The weight-based dose limits in this study were as follows:
Group A: ≥ 60 kg; maximum 15 mg/day Group B: 40-59 kg; maximum 9 mg/day Group C: 20-39 kg; maximum 6 mg/day Group D: \< 20 kg; maximum 3 mg/day
The decision to close the study early was based on data from 2 double-blind placebo-controlled studies (MEM-MD-57A and MEM-MD-68) that failed to demonstrate a statistically significant difference between memantine and placebo in the primary efficacy parameter based on Social Responsiveness Scale (SRS) total raw score.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 747 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 (NCT01592747) began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing. Patients who took open-label memantine in study MEM-MD-67 (NCT01999894) or MEM-MD-91(NCT01592786), received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
Drug: Memantine Hydrochloride (HCl)
During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily. During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily.
Also known as: Namenda
Patients With Any Treatment-emergent Adverse Event
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Time frame: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
Patient recruitment occurred over an eleven month period, from October of 2012 to September of 2013, at 106 study sites, located in the United States and 15 other countries.
| Milestone | Memantine |
|---|---|
| Started | 747 |
| Completed | 81 |
| Not completed | 666 |
| Withdrew: Study terminated by sponsor | 582 |
| Withdrew: Withdrawal by subject | 35 |
| Withdrew: Lost to follow-up | 19 |
| Withdrew: Adverse event | 17 |
| Withdrew: Lack of efficacy | 9 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Inclusion/exclusion not meet | 1 |
| Withdrew: Other reason | 1 |
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
| participants | Memantine |
|---|---|
| Patients With Any Treatment-emergent Adverse Event | 424 |
Collected over Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memantine | — | 8/747 (1.1%) | 150/747 (20.1%) |
| Event | Memantine |
|---|---|
| Abdominal painGastrointestinal disorders | 1/747 |
| Abdominal pain lowerGastrointestinal disorders | 1/747 |
| Abnormal behaviourNervous system disorders | 1/747 |
| AppendicitisInfections and infestations | 1/747 |
| DehydrationInvestigations | 1/747 |
| DysphoriaNervous system disorders | 1/747 |
| Foreign bodyInjury, poisoning and procedural complications | 1/747 |
| Homicidal ideationNervous system disorders | 1/747 |
| Rectal prolapseInjury, poisoning and procedural complications | 1/747 |
| Suicidal ideationNervous system disorders | 1/747 |
| Event | Memantine |
|---|---|
| NasopharyngitisInfections and infestations | 55/747 |
| VomitingGastrointestinal disorders | 51/747 |
| PyrexiaGeneral disorders | 47/747 |
| HeadacheNervous system disorders | 41/747 |
Demographic summaries were provided based on the 747 patients who received at least 1 dose of investigational product in the extension study (Safety Population).
| Age, Continuous(years) | Memantine |
|---|---|
| Mean | 9.0 ± 1.9 |
| Sex: Female, Male(Participants) | Memantine |
|---|---|
| Female | 120 |
| Male | 627 |
| Race/Ethnicity, Customized(participants) | Memantine |
|---|---|
| White | 636 |
| Black or African American | 42 |
| Asian | 44 |
| American Indian or Alaska Native | 2 |
| Native Hawaiian or Other Pacific Islander | 3 |
| Other Race | 20 |
| Race/Ethnicity, Customized(participants) | Memantine |
|---|---|
| Hispanic or Latino | 88 |
| Not Hispanic or Latino | 659 |
| Region of Enrollment(participants) | Memantine |
|---|---|
| United States | 586 |
| Belgium | 4 |
| Canada | 1 |
| Colombia | 8 |
| Estonia | 5 |
| France | 9 |
| Hungary | 14 |
| Iceland | 5 |
| Italy | 6 |
| Korea, Republic of | 22 |
| New Zealand | 1 |
| Poland | 36 |
| Serbia | 21 |
| South Africa | 1 |
| Spain | 14 |
| Ukraine | 14 |
Showing the first 100 of 106 sites across 16 countries.
This study is terminated, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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