Trial Outcomes & Findings for Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) (NCT NCT01592773)
NCT ID: NCT01592773
Last Updated: 2015-02-16
Results Overview
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
747 participants
Primary outcome timeframe
Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit
Results posted on
2015-02-16
Participant Flow
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.
Participant milestones
| Measure |
Memantine
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
|
|---|---|
|
Overall Study
STARTED
|
747
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
666
|
Reasons for withdrawal
| Measure |
Memantine
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
|
|---|---|
|
Overall Study
Study Terminated by Sponsor
|
582
|
|
Overall Study
Withdrawal by Subject
|
35
|
|
Overall Study
Lost to Follow-up
|
19
|
|
Overall Study
Adverse Event
|
17
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Inclusion/exclusion not meet
|
1
|
|
Overall Study
Other Reason
|
1
|
Baseline Characteristics
Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Baseline characteristics by cohort
| Measure |
Memantine
n=747 Participants
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
|
|---|---|
|
Age, Continuous
|
9.0 years
STANDARD_DEVIATION 1.9 • n=39 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
627 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
636 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
42 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
44 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
3 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
20 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
88 participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
659 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
586 participants
n=39 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=39 Participants
|
|
Region of Enrollment
Colombia
|
8 participants
n=39 Participants
|
|
Region of Enrollment
Estonia
|
5 participants
n=39 Participants
|
|
Region of Enrollment
France
|
9 participants
n=39 Participants
|
|
Region of Enrollment
Hungary
|
14 participants
n=39 Participants
|
|
Region of Enrollment
Iceland
|
5 participants
n=39 Participants
|
|
Region of Enrollment
Italy
|
6 participants
n=39 Participants
|
|
Region of Enrollment
Korea, Republic of
|
22 participants
n=39 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=39 Participants
|
|
Region of Enrollment
Poland
|
36 participants
n=39 Participants
|
|
Region of Enrollment
Serbia
|
21 participants
n=39 Participants
|
|
Region of Enrollment
South Africa
|
1 participants
n=39 Participants
|
|
Region of Enrollment
Spain
|
14 participants
n=39 Participants
|
|
Region of Enrollment
Ukraine
|
14 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final VisitPopulation: Analysis was performed on the 747 patients who took at least 1 dose of investigational product (Safety Population).
Number of patients who experienced 1 or more Treatment Emergent Adverse Event
Outcome measures
| Measure |
Memantine
n=747 Participants
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
|
|---|---|
|
Patients With Any Treatment-emergent Adverse Event
|
424 participants
|
Adverse Events
Memantine
Serious events: 8 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Memantine
n=747 participants at risk
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Nervous system disorders
Abnormal behaviour
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Infections and infestations
Appendicitis
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Investigations
Dehydration
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Nervous system disorders
Dysphoria
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Nervous system disorders
Homicidal ideation
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Injury, poisoning and procedural complications
Rectal prolapse
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Nervous system disorders
Suicidal ideation
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Gastrointestinal disorders
Vomiting
|
0.13%
1/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
Other adverse events
| Measure |
Memantine
n=747 participants at risk
To maintain the blind of the preceding study, patients who participated in MEM-MD-68 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 the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage.
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
6.8%
51/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
General disorders
Pyrexia
|
6.3%
47/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
55/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
|
Nervous system disorders
Headache
|
5.5%
41/747 • Adverse Event data was collected from October 2012 to February 2014 at 106 sites in the US and 15 other countries.
Safety results are based on the safety population (ie, all patients who took at least one dose of investigational product).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the PI will be subject to mutual agreement between the PI and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER