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Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine

Information source: Forest Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autism Spectrum Disorder (ASD); Autism; Autistic Disorder; Asperger's Disorder; Asperger's; Pediatric Autism; Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS); Pervasive Child Development Disorder

Intervention: Memantine Hydrochloride (HCl) (Drug); Memantine Hydrochloride (HCl) (Drug); Placebo capsules (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Forest Laboratories

Official(s) and/or principal investigator(s):
Jordan Lateiner, MS, MBA, Study Director, Affiliation: Forest Research Institute, Inc.- A Subsidiary of Forest Laboratories, Inc.

Summary

This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). The objective is to evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary outcome measure in this study will be the proportion of patients meeting the criterion for Loss of Therapeutic Response (LTR) by the end of the study.

Secondary outcome:

Children's Communication Checklist-2 (CCC-2)

Time to the first visit when a patient shows LTR following randomization to memantine or placebo (time to the first LTR)

Detailed description: This clinical study will be a 12-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) conducted at approximately 180 study centers. Patients who completed at least 12 weeks of study drug exposure during lead-in study MEM-MD-91 and meet protocol specified responder criteria.

Eligibility

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Completed at least 12 weeks of exposure to study drug in lead-in study MEM-MD-91 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 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 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

Locations and Contacts

Forest Investigative Site 204, Brussel 1020, Belgium

Forest Investigative Site 203, Bruxelles 1090, Belgium

Forest Investigative Site 202, Hoboken 2660, Belgium

Forest Investigative Site 227, Barranquilla, Colombia

Forest Investigative Site 228, Bello, Colombia

Forest Investigative Site 276, Tallinn 10617, Estonia

Forest Investigative Site 329, Bron Cedex 69677, France

Forest Investigative Site 376, Budapest 1083, Hungary

Forest Investigative Site 378, Budapest 1089, Hungary

Forest Investigative Site 379, Budapest 1021, Hungary

Forest Investigative Site 381, Budapest 1026, Hungary

Forest Investigative Site 382, Gyula 5700, Hungary

Forest Investigative Site 401, Kopavogur 200, Iceland

Forest Investigative Site 453, Roma 165, Italy

Forest Investigative Site 452, Siena 53100, Italy

Forest Investigative Site 701, Seoul 138-736, Korea, Republic of

Forest Investigative Site 702, Seoul 110744, Korea, Republic of

Forest Investigative Site 703, Seoul 120-752, Korea, Republic of

Forest Investigative Site 526, Wellington 6012, New Zealand

Forest Investigative Site 578, Gdansk 80-952, Poland

Forest Investigative Site 579, Gdansk 80-542, Poland

Forest Investigative Site 580, Kielce 25-317, Poland

Forest Investigative Site 576, Kobierzyce 55-040, Poland

Forest Investigative Site 577, Warszawa 02-957, Poland

Forest Investigative Site 626, Belgrade 11000, Serbia

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Forest Investigative Site 628, Novi Sad 21000, Serbia

Forest Investigative Site 729, Barcelona 8221, Spain

Forest Investigative Site 803, Donetsk 83008, Ukraine

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Forest Investigative Site 802, Kherson,Vil. Stepanivka 73488, Ukraine

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Forest Investigative Site 068, Dothan, Alabama 36303, United States

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Forest Investigative Site 730, Torremolinos, Málaga 29620, Spain

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Forest Investigative Site 081, Albuquerque, New Mexico 87108-5129, United States

Forest Investigative Site 107, Albuquerque, New Mexico 87109, United States

Forest Investigative Site 098, Bronx, New York 10467, United States

Forest Investigative Site 083, New York, New York 10032, United States

Forest Investigative Site 072, Chapel Hill, North Carolina 27514, United States

Forest Investigative Site 137, Fargo, North Dakota 58103, United States

Forest Investigative Site 069, Avon Lake, Ohio 44012, United States

Forest Investigative Site 015, Cleveland, Ohio 44106, United States

Forest Investigative Site 126, Cleveland, Ohio 44109, United States

Forest Investigative Site 134, Cleveland, Ohio 44106, United States

Forest Investigative Site 001, Columbus, Ohio 43210, United States

Forest Investigative Site 019, Oklahoma City, Oklahoma 73116, United States

Forest Investigative Site 092, Tulsa, Oklahoma 74104, United States

Forest Investigative Site 152, Toronto, Ontario M4G1R8, Canada

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Forest Investigative Site 053, Gresham, Oregon 97030, United States

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Forest Investigative Site 132, Johnstown, Pennsylvania 15904, United States

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Forest Investigative Site 100, Media, Pennsylvania 19063, United States

Forest Investigative Site 151, Montreal, Quebec H1Y3L1, Canada

Forest Investigative Site 105, Charleston, South Carolina 29407, United States

Forest Investigative Site 128, Sioux Falls, South Dakota 57105, United States

Forest Investigative Site 090, Memphis, Tennessee 38119, United States

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Forest Investigative Site 070, The Woodlands, Texas 77381, United States

Forest Investigative Site 028, Clinton, Utah 84015, United States

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Forest Investigative Site 064, Charlottesville, Virginia 22903, United States

Forest Investigative Site 113, Norfolk, Virginia 23507, United States

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Forest Investigative Site 071, Bothell, Washington 98011, United States

Forest Investigative Site 121, Seattle, Washington 98121, United States

Forest Investigative Site 119, Charleston, West Virginia 25304, United States

Forest Investigative Site 676, Cape Town, Western Cape 7530, South Africa

Forest Investigative Site 063, Middleton, Wisconsin 53562, United States

Forest Investigative Site 138, Milwaukee, Wisconsin 53201, United States

Additional Information

Starting date: September 2012
Last updated: October 31, 2013

Page last updated: August 23, 2015

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