Autism Spectrum Disorder (ASD)Phase 2NCT01592773
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
A Phase 2 study testing Memantine Hydrochloride (HCl) in people with Autism Spectrum Disorder (ASD) and Autism, run by Forest Laboratories at 106 sites in 16 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Autism, Autistic Disorder
- What is being tested?
- Memantine Hydrochloride (HCl)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 747 participants
- Where
- 106 sitesin 16 countries
- Study dates
- Oct 2012to Mar 2014
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
- Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
- Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study
Who cannot join
- Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
- Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
- Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior
Trial locations and contacts
106 sites in 16 countries.
106 sites in 16 countries
United States68 sites
Forest Investigative Site 081
Albuquerque, New Mexico, 87108-5129
Forest Investigative Site 107
Albuquerque, New Mexico, 87109
Forest Investigative Site 069
Avon Lake, Ohio, 44012
Forest Investigative Site 071
Bothell, Washington, 98011
Forest Investigative Site 078
Boulder, Colorado, 80304
Forest Investigative Site 075
Bradenton, Florida, 32751
Forest Investigative Site 073
Centennial, Colorado, 80112
Forest Investigative Site 072
Chapel Hill, North Carolina, 27514
Forest Investigative Site 105
Charleston, South Carolina, 29407
Forest Investigative Site 119
Charleston, West Virginia, 25304
Forest Investigative Site 064
Charlottesville, Virginia, 22903
Forest Investigative Site 028
Clinton, Utah, 84015
Forest Investigative Site 001
Columbus, Ohio, 43210
Forest Investigative Site 068
Dothan, Alabama, 36303
Forest Investigative Site 082
Evansville, Indiana, 47713
Forest Investigative Site 123
Fort Wayne, Indiana, 46805
Forest Investigative Site 080
Gainesville, Florida, 32607
Forest Investigative Site 054
Glendale, California, 91206
Forest Investigative Site 053
Gresham, Oregon, 97030
Forest Investigative Site 130
Henderson, Nevada, 89052
Forest Investigative Site 051
Houston, Texas, 77090
Forest Investigative Site 109
Imperial, California, 92251
Forest Investigative Site 056
Indianapolis, Indiana, 46260
Forest Investigative Site 066
Irvine, California, 92612
Forest Investigative Site 117
Jacksonville, Florida, 32216
Forest Investigative Site 132
Johnstown, Pennsylvania, 15904
Forest Investigative Site 095
Lake Charles, Louisiana, 70605
Forest Investigative Site 104
Las Vegas, Nevada, 89128
Forest Investigative Site 102
Libertyville, Illinois, 60048
Forest Investigative Site 116
Lincoln, Nebraska, 68516
Forest Investigative Site 097
Lincoln, Nebraska, 68526
Forest Investigative Site 077
Little Rock, Arkansas, 72202-3591
Forest Investigative Site 096
Los Angeles, California, 90024
Forest Investigative Site 061
Louisville, Kentucky, 40202
Forest Investigative Site 065
Maitland, Florida, 32751
Forest Investigative Site 131
McMurray, Pennsylvania, 15317
Forest Investigative Site 100
Media, Pennsylvania, 19063
Forest Investigative Site 090
Memphis, Tennessee, 38119
Forest Investigative Site 118
Miami, Florida, 33155
Forest Investigative Site 063
Middleton, Wisconsin, 53562
Forest Investigative Site 023
Naperville, Illinois, 60563
Forest Investigative Site 057
Nashville, Tennessee, 37232
Forest Investigative Site 136
Neptune City, New Jersey, 07753
Forest Investigative Site 091
New Orleans, Louisiana, 70112
Forest Investigative Site 059
Newton, Massachusetts, 02459
Forest Investigative Site 113
Norfolk, Virginia, 23507
Forest Investigative Site 085
Oakland Park, Florida, 33334
Forest Investigative Site 141
Ogden, Utah, 84405
Forest Investigative Site 019
Oklahoma City, Oklahoma, 73116
Forest Investigative Site 115
Orange City, Florida, 32763
Forest Investigative Site 125
Orlando, Florida, 32803
Forest Investigative Site 062
Orlando, Florida, 32806
Forest Investigative Site 005
Phoenix, Arizona, 85006
Forest Investigative Site 124
Roanoke, Virginia, 24014
Forest Investigative Site 086
Rockville, Maryland, 20852
Forest Investigative Site 029
Salt Lake City, Utah, 84106
Forest Investigative Site 021
San Francisco, California, 94143-0984
Forest Investigative Site 026
Santa Ana, California, 92701
Forest Investigative Site 108
Springfield, Massachusetts, 01199
Forest Investigative Site 002
Stanford, California, 94305-5719
Forest Investigative Site 067
Tampa, Florida, 33613
Forest Investigative Site 098
The Bronx, New York, 10467
Forest Investigative Site 070
The Woodlands, Texas, 77381
Forest Investigative Site 127
Toms River, New Jersey, 08755
Forest Investigative Site 055
Tucson, Arizona, 85718
Forest Investigative Site 092
Tulsa, Oklahoma, 74104
Forest Investigative Site 052
Washington D.C., District of Columbia, 20010-2970
Forest Investigative Site 101
Wellington, Florida, 33414
Poland5 sites
Forest Investigative Site 579
Gdansk, 80542
Forest Investigative Site 578
Gdansk, 80952
Forest Investigative Site 580
Kielce, 25317
Forest Investigative Site 576
Tyniec Mały, 55040
Forest Investigative Site 577
Warsaw, 80214
Ukraine5 sites
Forest Investigative Site 803
Donetsk, 83008
Forest Investigative Site 807
Kharkiv, 61153
Forest Investigative Site 802
Kherson, 73488
Forest Investigative Site 804
Kyiv, 4080
Forest Investigative Site 801
Odesa, 65014
Hungary4 sites
Forest Investigative Site 381
Budapest, 1026
Forest Investigative Site 376
Budapest, 1083
Forest Investigative Site 378
Budapest, 1089
Forest Investigative Site 382
Gyula, 5700
Serbia4 sites
Forest Investigative Site 626
Belgrade, 11000
Forest Investigative Site 627
Belgrade, 11000
Forest Investigative Site 629
Niš, 18000
Forest Investigative Site 628
Novi Sad, 21000
South Korea4 sites
Forest Investigative Site 702
Seoul, 110744
Forest Investigative Site 703
Seoul, 120752
Forest Investigative Site 701
Seoul, 138736
Forest Investigative Site 704
Yangsan, Gyeongsangnam-do, 626-770
Colombia3 sites
Forest Investigative Site 228
Antioquia, Bello
Forest Investigative Site 227
Barranquilla, 84176
Forest Investigative Site 226
Bogotá
Spain3 sites
Forest Investigative Site 729
Barcelona, 08221
Forest Investigative Site 728
Sabadell, 08208
Forest Investigative Site 730
Torremolinos, 29620
Belgium2 sites
Forest Investigative Site 204
Brussels, 1020
Forest Investigative Site 203
Jette, 1090
Italy2 sites
Forest Investigative Site 453
Roma, 00165
Forest Investigative Site 452
Siena, 53100
South Africa1 site
Forest Investigative Site 676
Bellville Cape Town, 7530
About this study
Official title: An Open-Label Extension Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
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).
Read the detailed description
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:
- completed the open-label Study MEM MD 67,or
- completed the open-label Study MEM-MD-91, or
- completed the double-blind Study MEM-MD-68, or
- discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response
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.
- Conditions
- Autism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism
- Being tested
- Memantine Hydrochloride (HCl)
- Keywords
- Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Pervasive Child Development Disorder
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memantine Hydrochloride (HCl)Drug
Also called Namenda
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.
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Experimental | 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. Receives: Drug: Memantine Hydrochloride (HCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Any Treatment-emergent Adverse Event
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Measured: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionMar 2014
Why it stopped: Terminated because primary efficacy parameter failed to demonstrate statistically significant difference between memantine and placebo in controlled trials
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 Autism Spectrum Disorder (ASD)Studies 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
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordan Lateiner, MS, MBA, Study director, Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592773
- Sponsor's protocol ID
- MEM-MD-69
- Status last verified
- Jan 2015
- First submitted
- 3 May 2012
- Last updated
- 16 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 16 Feb 2015. 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, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
- ClinicalTrials.gov ID
- NCT01592773
- Acronym / sponsor ID
- MEM-MD-69
- Conditions
- Autism Spectrum Disorder (ASD), Autism, Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism
- Keywords
- Autistic Disorder, Asperger's Disorder, Asperger's, Pediatric Autism, Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), Pervasive Child Development Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated because primary efficacy parameter failed to demonstrate statistically significant difference between memantine and placebo in controlled trials
- Enrolment
- 747 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Posted 16 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- completed the open-label Study MEM MD 67,or
- completed the open-label Study MEM-MD-91, or
- completed the double-blind Study MEM-MD-68, or
- discontinued study MEM-MD-68 by meeting requirements for loss of therapeutic response
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.
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 Hydrochloride (HCl)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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients who completed Study MEM-MD-67, MEM-MD-68, MEM-MD-91, or discontinued Study MEM-MD-68 due to meeting the criterion for loss of therapeutic response.
- Having normal results from a physical examination and laboratory tests at Visit 1 of this study (last visit of the preceding study). Any abnormal findings must be deemed not clinically significant by the Investigator and documented as such.
- Have a family that is sufficiently organized and stable to guarantee adequate safety monitoring and continuous attendance to clinic visits for the duration of the study
Key exclusion criteria (3 listed)
- Patients who discontinued a preceding memantine study due to an adverse event possibly related to study drug
- Patients with a concurrent medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger the patient's well being
- Significant risk of suicidality based on the Investigator's judgment, Aberrant Behavior Checklist-irritability subscale (ABC-I), or if appropriate, as indicated by a response of "yes" to questions 4 or 5 in the suicidal ideation section of the Children's Columbia-Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior
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 Hydrochloride (HCl)Also: NamendaDuring 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. | Drug | Memantine |
Primary outcome
Patients With Any Treatment-emergent Adverse Event
Time frame: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
- 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.
Jordan Lateiner, MS, MBA study director
Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
106 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine Hydrochloride (HCl) in people with Autism Spectrum Disorder (ASD) and Autism, run by Forest Laboratories at 106 sites in 16 countries.
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 3 inclusion and 3 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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Poland, Ukraine, Hungary, Serbia and 11 more countries. 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 16 Feb 2015). 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?
Patients With Any Treatment-emergent Adverse Event (time frame: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit). 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 NCT01592773, 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 16 Feb 2015.