AutismPhase 2NCT00872898

Study of Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Children With Autism

A Phase 2 study testing Memantine - Extended Release (ER) in people with Autism, run by Forest Laboratories at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism. Read more about this study

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Autism
What is being tested?: Memantine - Extended Release (ER)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 124 participants
Where: 17 sitesUnited States
Study dates: Apr 2009to Aug 2012
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

Males or females ages 6 to 12 years
Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 \& 3).
A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
Patients over age 12, only if they completed Study MEM-PK-21

Who cannot join

Medical history of active epilepsy/seizure disorder except simple febrile seizures
Participation in any other clinical investigation using an experimental drug within 30 days of the start of this study

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Forest Investigative Site
Cambridge, Massachusetts, 02138
Forest Investigative Site
Cleveland, Ohio, 44106
Forest Investigative Site
Columbus, Ohio, 43210
Forest Investigative Site
Hoffman Estates, Illinois, 60169
Forest Investigative Site
Indianapolis, Indiana, 46202
Forest Investigative Site
Jacksonville Beach, Florida, 32250
Forest Investigative Site
Manhasset, New York, 11030
Forest Investigative site
Naperville, Illinois, 60563
Forest Investigative Site
Oklahoma City, Oklahoma, 73116
Forest Investigative Site
Phoenix, Arizona, 85006
Forest Investigative Site
Sacramento, California, 95817
Forest Investigative Site
San Francisco, California, 94143
Forest Investigative Site
Santa Ana, California, 92705
Forest Investigative Site
St. Petersburg, Florida, 33701
Forest Investigative Site
Stanford, California, 94305
Forest Investigative Site
Toms River, New Jersey, 08755
Forest Investigative Site
Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

Official title: An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism

The purpose of this study is to investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

Read the detailed description

This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism.

Patients participating in Part One will receive a single open-label dose of memantine. Blood samples for pharmacokinetic analysis will be collected.

Part Two is a randomized, double-blind, placebo-controlled 12-week efficacy and safety study evaluating change in all core domains (social interactions, communication, and restricted interests and repetitive behaviors) of autism.

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
Being tested: Memantine - Extended Release (ER), Placebo
Keywords: autism, memantine, pediatric, Forest Laboratories, Autism in pediatric patients
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 - Extended Release (ER)Drug
Also called Namenda ER
Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.
PlaceboDrug
Placebo capsules, once daily, oral administration.

Study groups in NCT00872898
Study group	Role	What they receive
1	Experimental	Once daily oral administration of memantine for 12 weeks. Receives: Drug: Memantine - Extended Release (ER)
2	Placebo comparator	Once daily oral administration of placebo for 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Extent of Absorption of Memantine (Part One)
Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.
Measured: Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose
Change in Total Raw Score of Social Responsiveness Scale
The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment).
Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment.
Measured: From Baseline to Week 12

Secondary outcomes (13)

Core Autism Treatment Scale-Improvement: Total Score
The Core Autism Treatment Scale-Improvement (CATS-I) is based on rating 14 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 14 (improved) to 98 (worsened).
The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).
Measured: At Week 12
Core Autism Treatment Scale-Improvement: Social Interaction
The Core Autism Treatment Scale-Improvement (CATS-I) Social Interaction Subscale is based on rating 9 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 9 (improved) to 63 (worsened).
The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).
Measured: At Week 12
Core Autism Treatment Scale-Improvement: Communication
The Core Autism Treatment Scale-Improvement (CATS-I) Communication Subscale is based on rating 5 items from 1 (very much improved) to 7 (very much worse) with a total score ranging from 5 (improved) to 35 (worsened).
The Core Autism Treatment Scale-Improvement (CATS-I) is designed to utilize a comparison between pretreatment ratings of Core Autism Treatment Scale-Severity (CATS-S) and ratings of improvement after start of therapy (CATS-I). Both parts of the CATS contain 14 items testing for social interaction (items 1-9) and communication (items 10-14). Each of these items is rated from 1 (indicating most benign) to 7 (indicating most severe).
Measured: At Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale
The Children's Communication Checklist-2 (CCC-2) Speech Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale
The Children's Communication Checklist-2 (CCC-2) Syntax Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale
The Children's Communication Checklist-2 (CCC-2) Semantics Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale
The Children's Communication Checklist-2 (CCC-2) Coherence Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale
The Children's Communication Checklist-2 (CCC-2) Initiation Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale
The Children's Communication Checklist-2 (CCC-2) Scripted Language Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale
The Children's Communication Checklist-2 (CCC-2) Context Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale
The Children's Communication Checklist-2 (CCC-2) Nonverbal Communication Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale
The Children's Communication Checklist-2 (CCC-2) Social Relations Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale
The Children's Communication Checklist-2 (CCC-2) Interests Subscale consists of 7 items rated from 0 (less than once a week or never) to 3 (several times [more than twice] a day or always), with a total raw score of 0 (mildest) to 21 (most severe).
The Children's Communication Checklist-2 (CCC-2) is a validated, norm-referenced, informant-rated scale that evaluates difficulties children may have (across 10 different subscales, consisting of 7 items each) that affect communication (items 1-50), as well as strengths that children may demonstrate when communicating with others (items 51-70).
Measured: From Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Aug 2012

First posted31 Mar 2009 (estimated)
Study startApr 2009
Primary completionAug 2012

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.
Publications (2)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00872898
Sponsor's protocol ID: MEM-MD-57A
Status last verified: Nov 2013
First submitted: 30 Mar 2009
Last updated: 14 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
PubMed 37811711
Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.
PubMed 36006807

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label (Part One) and a Randomized, Double-blind, Placebo-Controlled (Part Two) Study of the Pharmacokinetics, Safety, Efficacy, and Tolerability of Memantine in Pediatric Patients With Autism
ClinicalTrials.gov ID: NCT00872898
Acronym / sponsor ID: MEM-MD-57A
Conditions: Autism
Keywords: autism, memantine, pediatric, Forest Laboratories, Autism in pediatric patients
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Merz Pharmaceuticals GmbH
Study start: Apr 2009
Primary completion: Aug 2012 (actual)
First posted: 31 Mar 2009 (estimated)
Results: Posted 14 Jan 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 investigate the safety and efficacy of memantine extended release, as well as its extent of absorption in pediatric patients with autism.

Detailed description

This is a multicenter, two-part study in pediatric (ages 6 to 18 years) patients diagnosed with autism.

Patients participating in Part One will receive a single open-label dose of memantine. Blood samples for pharmacokinetic analysis will be collected.

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Memantine - Extended Release (ER)Once daily oral administration of memantine for 12 weeks.
2	Placebo comparator	Drug: PlaceboOnce daily oral administration of placebo for 12 weeks.

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Males or females ages 6 to 12 years
Diagnosis of autistic disorder, according to DSM-IV-TR using Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule (modules 2 \& 3).
A knowledgeable caregiver capable of providing reliable information about the patient's condition, able to attend all clinic visits with the patient
Patients over age 12, only if they completed Study MEM-PK-21

Key exclusion criteria (2 listed)

Medical history of active epilepsy/seizure disorder except simple febrile seizures
Participation in any other clinical investigation using an experimental drug within 30 days of the start of this 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 - Extended Release (ER)Also: Namenda ERMemantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally.	Drug	1
PlaceboPlacebo capsules, once daily, oral administration.	Drug	2

Primary outcome

Extent of Absorption of Memantine (Part One)
Time frame: Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose
Area under the plasma concentration vs. time curve (AUC) for memantine, as measured in units of nanogram x hours per milliliter.
Change in Total Raw Score of Social Responsiveness Scale
Time frame: From Baseline to Week 12
The Social Responsiveness Scale (SRS) is a 65-item informant-rated assessment, ranging from 0 (no impairment) to 195 (severe social impairment). Each item is associated with 1 of 5 subscales (social awareness, social cognition, social communication, social motivation and autistic mannerisms). Each item is rated on a 4-point scale from 1 (not true) to 4 (almost always true). The scores are then transposed to a scale from 0 to 3 and scores are summed within each of the 5 subscales. A higher score indicates greater severity of social impairment.

13 secondary outcomes

Core Autism Treatment Scale-Improvement: Total Score
Time frame: At Week 12
Core Autism Treatment Scale-Improvement: Social Interaction
Time frame: At Week 12
Core Autism Treatment Scale-Improvement: Communication
Time frame: At Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Speech Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Context Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale
Time frame: From Baseline to Week 12
Change in Children's Communication Checklist-2 (CCC-2) - Interests Subscale
Time frame: From Baseline to Week 12

Results and safety

Results posted to the registry on 14 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	0	0
Memantine	4	4

Primary outcome: Extent of Absorption of Memantine (Part One)

Time frame: Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose. Mean (Standard Deviation). Unit: ng•h/mL

Measure	Memantine n = 4
Value	682.53 (217.77)

Population analysed: Four patients enrolled in Part One, receiving a single dose of memantine and having evaluable pharmacokinetic parameters (Pharmacokinetic Population)

Primary outcome: Change in Total Raw Score of Social Responsiveness Scale

Time frame: From Baseline to Week 12. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 53	Memantine n = 54
Value	-9.5 (2.6)	-9.6 (2.5)

Placebo vs Memantine: Least squares mean difference: -0.1 (95% CI -7.2 to 7.0), p = 0.9781, mixed-model for repeated measures

Population analysed: All of the the 121 randomized patients in Part Two of the study, received at least 1 dose of study drug. The protocol specified Intent-to-Treat (ITT) Population consisted of 107 patients who had at least 1 postbaseline assessment of SRS.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data for Part One of this study was collected over a 14-month period from May 2009 to July of 2010. Adverse event data for Part Two of this study was collected over a 38-month period from July of 2009 to September of 2012.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Part Two, Double-Blind Treatment	0 of 61 (0%)	31 of 61 (50.8%)	Not reported
Memantine - Part Two, Double-Blind Treatment	1 of 60 (1.7%)	37 of 60 (61.7%)	Not reported
Memantine - Part One, Open Label Treatment	0 of 4 (0%)	1 of 4 (25%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37811711Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
Derived from this study: PubMed 36006807Brignell A, Marraffa C, Williams K, May T. Memantine for autism spectrum disorder. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013845. doi: 10.1002/14651858.CD013845.pub2.

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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 Research Institute, a subsidiary of Forest Laboratories, Inc.

17 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 - Extended Release (ER) in people with Autism, run by Forest Laboratories at 17 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 4 inclusion and 2 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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. Some participants in this study may receive a placebo. 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 14 Jan 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?

Extent of Absorption of Memantine (Part One) (time frame: Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00872898, which also lists 2 linked publications.

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 14 Jan 2014.