Trial Outcomes & Findings for Open-label Study of Safety and Tolerability of Memantine in Children With Autism (NCT NCT01999894)
NCT ID: NCT01999894
Last Updated: 2014-03-18
Results Overview
Number of patients who experienced one or more TEAEs during the study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)
Results posted on
2014-03-18
Participant Flow
Patients who completed the lead-in study MEM-MD-57A (NCT00872898) were eligible to enroll in this study. A total of 19 study centers in the United States enrolled patients.
Patients receiving placebo in the lead-in study underwent a double-blind up-titration targeting same weight-based dose assigned at lead-in study. Patients receiving a stable dose of active were not re-titrated but double-blind was maintained. Patients who were not dosed for more than 3 days between the studies underwent an open-label titration.
Participant milestones
| Measure |
Memantine
Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
Memantine
Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Other Reason
|
3
|
|
Overall Study
Inclusion/exclusion criteria not met
|
1
|
Baseline Characteristics
Open-label Study of Safety and Tolerability of Memantine in Children With Autism
Baseline characteristics by cohort
| Measure |
Memantine
n=102 Participants
Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
|---|---|
|
Age, Continuous
Years
|
9.1 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
86 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Latino
|
91 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 1) to 30 days after Visit 8 (Week 48)Population: The Safety Population consists of 102 enrolled patients who received at least one dose of study drug.
Number of patients who experienced one or more TEAEs during the study
Outcome measures
| Measure |
Memantine
n=102 Participants
Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
|---|---|
|
Number of Patients Who Experienced a Treatment-emergent Adverse Event (TEAE)
|
85 participants
|
Adverse Events
Placebo to Memantine
Serious events: 1 serious events
Other events: 37 other events
Deaths: 0 deaths
Memantine to Memantine
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo to Memantine
n=50 participants at risk
Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
Memantine to Memantine
n=52 participants at risk
Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
|---|---|---|
|
Infections and infestations
Lobar pneumonia
|
2.0%
1/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
0.00%
0/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
Other adverse events
| Measure |
Placebo to Memantine
n=50 participants at risk
Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
Memantine to Memantine
n=52 participants at risk
Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.0%
5/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
3.8%
2/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
6/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
3.8%
2/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
General disorders
Irritability
|
4.0%
2/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
9.6%
5/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
General disorders
Pyrexia
|
2.0%
1/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
9.6%
5/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Immune system disorders
Seasonal allergy
|
14.0%
7/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
3.8%
2/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
3/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
7.7%
4/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
5/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
19.2%
10/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Investigations
Weight increased
|
10.0%
5/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
7.7%
4/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Nervous system disorders
Headache
|
8.0%
4/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
5.8%
3/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
6.0%
3/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
5.8%
3/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Psychiatric disorders
Aggression
|
10.0%
5/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
5.8%
3/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Psychiatric disorders
Agitation
|
4.0%
2/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
7.7%
4/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Psychiatric disorders
Insomnia
|
10.0%
5/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
5.8%
3/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
5/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
9.6%
5/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
5/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
5.8%
3/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Infections and infestations
Ear Infection
|
2.0%
1/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
7.7%
4/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Infections and infestations
Influenza
|
6.0%
3/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
3.8%
2/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
7.7%
4/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Infections and infestations
Bronchitis
|
6.0%
3/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
0.00%
0/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
4.0%
2/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
5.8%
3/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Psychiatric disorders
Stereotypy
|
2.0%
1/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
7.7%
4/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Psychiatric disorders
Anxiety
|
6.0%
3/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
1.9%
1/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
4/50 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
1.9%
1/52 • Adverse event data was collected over a 40 month period from November 2009 to March 2013 at 19 study sites in the US.
|
Additional Information
Ephraim Katz, PhD / Associate Director
Forest Research Institute
Phone: 201-427-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All data generated in this study are 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 Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
- Publication restrictions are in place
Restriction type: OTHER