AutismPhase 2NCT01999894
Open-label Study of Safety and Tolerability of Memantine in Children With Autism
A Phase 2 study testing Memantine HCl in people with Autism and Pediatric Autism, run by Forest Laboratories at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Autism, Pediatric Autism
- What is being tested?
- Memantine HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 19 sitesUnited States
- Study dates
- Nov 2009to Feb 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Patients with a concurrent medical condition that might interfere with the conduct of the study
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Forest Investigative Site 025
Cambridge, Massachusetts, 02138
Forest Investigative Site 013
Cleveland, Ohio, 44106
Forest Investigative Site 015
Cleveland, Ohio, 44106
Forest Investigative Site 001
Columbus, Ohio, 43210
Forest Investigative Site 014
Hoffman Estates, Illinois, 60169
Forest Investigative Site 010
Indianapolis, Indiana, 46202
Forest Investigative Site 024
Jacksonville Beach, Florida, 32250
Forest Investigative Site 017
Manhasset, New York, 10030
Forest Investigative Site 023
Naperville, Illinois, 60563
Forest Investigative Site 019
Oklahoma City, Oklahoma, 73116
Forest Investigative Site 005
Phoenix, Arizona, 85006
Forest Investigative Site 003
Sacramento, California, 95817
Forest Investigative Site 021
San Francisco, California, 94143
Forest Investigative Site 026
Santa Ana, California, 92701
Forest Investigative Site 020
Santa Ana, California, 92705
Forest Investigative Site 007
St. Petersburg, Florida, 33701
Forest Investigative Site 002
Stanford, California, 94305
Forest Investigative Site 011
Toms River, New Jersey, 08755
Forest Investigative Site 006
Voorhees Township, New Jersey, 08043
About this study
Official title: An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism
The purpose of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of autism in pediatric patients.
Read the 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
- Conditions
- Autism, Pediatric Autism
- Being tested
- Memantine HCl
- Keywords
- Namenda, Autism, Memantine, Pediatric, Forest Laboratories
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine HClDrug
Also called Namenda, Namenda XR
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.
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | Once daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period. Receives: Drug: Memantine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
Number of patients who experienced one or more TEAEs during the study
Measured: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2013 (estimated)
- Study startNov 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merz Pharmaceuticals GmbH
- Responsible party
- Sponsor
- Investigators
- Ephraim Katz, PhD, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01999894
- Sponsor's protocol ID
- MEM-MD-67
- Status last verified
- Jan 2014
- First submitted
- 26 Nov 2013
- Last updated
- 18 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism
- ClinicalTrials.gov ID
- NCT01999894
- Acronym / sponsor ID
- MEM-MD-67
- Conditions
- Autism, Pediatric Autism
- Keywords
- Namenda, Autism, Memantine, Pediatric, Forest Laboratories
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Merz Pharmaceuticals GmbH
- Study start
- Nov 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Dec 2013 (estimated)
- Results
- Posted 18 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memantine | Experimental | Drug: Memantine HClOnce daily oral administration of memantine for 48 weeks: 6-week double-blind dose-titration period followed by a 42-week maintenance period. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a concurrent medical condition that might interfere with the conduct of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memantine HClAlso: Namenda, Namenda XRMemantine 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. | Drug | Memantine |
Primary outcome
Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ephraim Katz, PhD study director
Forest Laboratories
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine HCl in people with Autism and Pediatric Autism, run by Forest Laboratories at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE) (time frame: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2014.