AutismNCT01078844
Memantine in Adult Autism Spectrum Disorder
A study testing memantine in people with Autism and Asperger's Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS
- What is being tested?
- memantine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jul 2010
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)
- Participant has a diagnosis of:
- Autistic Disorder
- Asperger's Disorder
- Pervasive Developmental Disorder (PDD) NOS
- Participant meets one of the following criteria:
Show all 11Show fewer
- CGI-S >= 4 (CGI-S: ________)
- Participant has the following problematic behaviors (at least one) that might be expected to benefit from memantine:
- _____________________________________________
- _____________________________________________
- _____________________________________________
Who cannot join
- The patient meets none of the following criteria (mark if absent):
- Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible).
- Rett's Syndrome or Childhood Disintegrative Disorder
- Active treatment with an acetylcholinesterase inhibitor
- Prior or current treatment with memantine
- Current treatment with lamotrigine
Show all 10Show fewer
- Genetic, metabolic or degenerative disorder (excepting Fragile X).
- Brain malformation or known severe brain trauma
- Pregnancy or breastfeeding
- Glomerular Filtration Rate (GFR) < 30 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).
- Being tested
- memantine, Placebo
- Keywords
- Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS, Adult, Memantine
- Medical subject headings
- Autistic Disorder, Asperger Syndrome, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memantineDrug
memantine 5-20 mg daily
PlaceboDrug
Look-alike placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Treatment as usual plus placebo Receives: Drug: Placebo |
| memantine | Active comparator | Treatment as usual plus memantine Receives: Drug: memantine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression-Scale(CGI-S)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Sponsor withdrew funds
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 (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Eric Samstad, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078844
- Sponsor's protocol ID
- NA_00015760
- Status last verified
- Jun 2017
- First submitted
- 1 Mar 2010
- Last updated
- 26 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memantine in Adult Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01078844
- Acronym / sponsor ID
- NA_00015760
- Keywords
- Autism, Asperger's Disorder, Pervasive Developmental Disorder NOS, Adult, Memantine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor withdrew funds
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Feb 2010 (actual)
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Posted 26 Jul 2017
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 see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder not otherwise specified (NOS).
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboTreatment as usual plus placebo |
| memantine | Active comparator | Drug: memantineTreatment as usual plus memantine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant is currently in treatment in the Johns Hopkins Bayview Medical Center (JHBMC)
- Participant has a diagnosis of:
- Participant meets one of the following criteria:
Key exclusion criteria (10 listed)
- Active seizures (Patients with a history of seizures, who have been seizure-free on an antiepileptic regimen for six months or more would be eligible).
- Rett's Syndrome or Childhood Disintegrative Disorder
- Active treatment with an acetylcholinesterase inhibitor
- Prior or current treatment with memantine
- Current treatment with lamotrigine
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 |
|---|---|---|
| memantinememantine 5-20 mg daily | Drug | memantine |
| PlaceboLook-alike placebo | Drug | Placebo |
Primary outcome
Clinical Global Impression-Scale(CGI-S)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Eric Samstad, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing memantine in people with Autism and Asperger's Disorder, run by Johns Hopkins University at 1 site 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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2017). 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?
Clinical Global Impression-Scale(CGI-S) (time frame: 12 weeks). 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 NCT01078844, which also lists 1 linked publication.
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 26 Jul 2017.