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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01592747




Registration number
NCT01592747
Ethics application status
Date submitted
3/05/2012
Date registered
7/05/2012
Date last updated
24/04/2019

Titles & IDs
Public title
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
Scientific title
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated With Memantine
Secondary ID [1] 0 0
MEM-MD-68
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autistic Disorder 0 0
Autism 0 0
Asperger's Disorder 0 0
Asperger Syndrome 0 0
Autism Spectrum Disorders 0 0
Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Autistic spectrum disorders
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Memantine Hydrochloride (HCl)
Treatment: Drugs - Memantine Hydrochloride (HCl)
Treatment: Drugs - Placebo capsules

Experimental: Memantine 1 - Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight-based dose achieved in lead-in Study MEM-MD-91. Dosing will be once daily for up to 12 weeks.

Experimental: Memantine 2 - Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%. Dosing will be once daily for up to 12 weeks.

Placebo comparator: Placebo - Dosing will be once daily for up to 12 weeks.


Treatment: Drugs: Memantine Hydrochloride (HCl)
Extended Release Dose ranging from 3-15mg/day; administered orally

Treatment: Drugs: Memantine Hydrochloride (HCl)
Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.

Treatment: Drugs: Placebo capsules
Once daily, oral administration.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases)
Timepoint [1] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [1] 0 0
Time to First Loss of Therapeutic (LTR) Response
Timepoint [1] 0 0
Baseline to week 12
Secondary outcome [2] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Speech Subscale at Week 12
Timepoint [2] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [3] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Syntax Subscale at Week 12
Timepoint [3] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [4] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Semantics Subscale at Week 12
Timepoint [4] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [5] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Coherence Subscale at Week 12
Timepoint [5] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [6] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Initiation Subscale at Week 12
Timepoint [6] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [7] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Scripted Language Subscale at Week 12
Timepoint [7] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [8] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Context Subscale at Week 12
Timepoint [8] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [9] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Nonverbal Communication Subscale at Week 12
Timepoint [9] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [10] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Social Relations Subscale at Week 12
Timepoint [10] 0 0
Baseline (Visit 1) to week 12
Secondary outcome [11] 0 0
Change From Baseline in Children's Communication Checklist-2 (CCC-2) - Interests Subscale at Week 12
Timepoint [11] 0 0
Baseline (Visit 1) to week 12

Eligibility
Key inclusion criteria
1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 (NCT01592786)
2. Met responder criterion at two consecutive visits separated by at least two weeks in lead-in study MEM-MD-91
3. Provide written informed assent, when developmentally appropriate, to participate in the study before conduct of any study-specific procedures. The parent/guardian/LAR must provide written informed consent before the patient's participation in the study. A separate written informed consent for the caregiver must also be obtained before the conduct of any study specific procedures
4. Have a knowledgeable caregiver who is capable of providing reliable information about the patient's condition, attending all clinic visits with the patient, and overseeing the administration of study drug. Every effort should be made to maintain the same caregiver as used in the lead-in study throughout this study
5. Have normal results from the physical examination, laboratory tests, ECG, and vital signs at Visit 1 of this study (last visit of Study MEM-MD-91). Any abnormal findings must be deemed not clinically significant by the Investigator and documented
6. Be able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), as well as have a caregiver and parent/guardian/LAR who is able to speak and understand English sufficiently (or their native language if this can be accommodated by the site), to comprehend the nature of the study and to allow for the completion of all study assessments
7. 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
8. Females who are 9 years and older or who have had onset of menses must have a negative urine pregnancy test at Visit 1
9. Age of 6 years to 12 years at the time of entry into lead in study MEM-MD-91
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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
2. Significant risk of suicidality based on the Investigator's judgment, the 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 C-SSRS (Columbia-Suicide Severity Rating Scale) or any suicidal behavior.
3. Patients with evidence or history of malignancy (other than excised basal cell carcinoma) or any significant hematologic, endocrine, cardiovascular (including any rhythm disorder), neurologic, respiratory, renal, hepatic, or gastrointestinal disease
4. Female patients of child-bearing potential who are not using or not willing to use a conventional method of contraception approved by the PI. Abstinence is an acceptable method of contraception
5. Patients requiring treatment with prohibited concomitant medications
6. Patients who, in the opinion of the Investigator, might not be suitable for the study
7. Employee or immediate relative of an employee of Forest Laboratories, Inc., any of its affiliates or partners, or the study center

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
479
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Utah
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
United States of America
State/province [30] 0 0
West Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussel
Country [33] 0 0
Belgium
State/province [33] 0 0
Bruxelles
Country [34] 0 0
Colombia
State/province [34] 0 0
Bello
Country [35] 0 0
Colombia
State/province [35] 0 0
Bogotá
Country [36] 0 0
Estonia
State/province [36] 0 0
Tallinn
Country [37] 0 0
France
State/province [37] 0 0
Bron Cedex
Country [38] 0 0
Hungary
State/province [38] 0 0
Budapest
Country [39] 0 0
Iceland
State/province [39] 0 0
Kopavogur
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
Country [41] 0 0
Italy
State/province [41] 0 0
Siena
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Gyeongsangnam-do
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
New Zealand
State/province [44] 0 0
Wellington
Country [45] 0 0
Poland
State/province [45] 0 0
Gdansk
Country [46] 0 0
Poland
State/province [46] 0 0
Kobierzyce
Country [47] 0 0
Poland
State/province [47] 0 0
Warszawa
Country [48] 0 0
Serbia
State/province [48] 0 0
Belgrade
Country [49] 0 0
Serbia
State/province [49] 0 0
Nis
Country [50] 0 0
Serbia
State/province [50] 0 0
Novi Sad
Country [51] 0 0
South Africa
State/province [51] 0 0
Western Cape
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Ukraine
State/province [53] 0 0
Kharkiv
Country [54] 0 0
Ukraine
State/province [54] 0 0
Kherson,Vil. Stepanivka
Country [55] 0 0
Ukraine
State/province [55] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Forest Laboratories
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).
Trial website
https://clinicaltrials.gov/study/NCT01592747
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Jordan Lateiner, MS, MBA
Address 0 0
Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01592747