Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Autism Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01592773
• Other study ID #: MEM-MD-69
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2012
• Last updated: January 30, 2015
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: January 2015
• Source: Forest Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Public Health Agency of CanadaColombia: Ministry of Health and Social ProtectionEstonia: The State Agency of MedicineFrance: Ministry of HealthHungary: Research Ethics Medical CommitteeIceland: Ministry of Health and Social SecurityItaly: Ethics CommitteeNew Zealand: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSerbia: Medicines and Medical Devices AgencySingapore: Ministry of HealthSouth Africa: Medicines Control CouncilSouth Korea: Korea Food and Drug Administration (KFDA)Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 747
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asperger Syndrome
• Asperger's
• Asperger's Disorder
• Autism
• Autism Spectrum Disorder (ASD)
• Autistic Disorder
• Child Development Disorders, Pervasive
• Developmental Disabilities
• Disease
• Pediatric Autism
• Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Intervention

Drug:
• Memantine Hydrochloride (HCl)
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.

Locations

Country	Name	City	State
Belgium	Forest Investigative Site 204	Brussels
Belgium	Forest Investigative Site 203	Jette
Canada	Forest Investigative Site 155	Toronto	Ontario
Colombia	Forest Investigative Site 228	Antioquia	Bello
Colombia	Forest Investigative Site 227	Barranquilla
Colombia	Forest Investigative Site 226	Bogota
Estonia	Forest Investigative Site 276	Tallinn
France	Forest Investigative Site 329	Bron Cedex	Rhone
Hungary	Forest Investigative Site 376	Budapest
Hungary	Forest Investigative Site 378	Budapest
Hungary	Forest Investigative Site 381	Budapest
Hungary	Forest Investigative Site 382	Gyula
Iceland	Forest Investigative Site 401	Kopavogur
Italy	Forest Investigative Site 453	Roma
Italy	Forest Investigative Site 452	Siena
Korea, Republic of	Forest Investigative Site 701	Seoul
Korea, Republic of	Forest Investigative Site 702	Seoul
Korea, Republic of	Forest Investigative Site 703	Seoul
Korea, Republic of	Forest Investigative Site 704	Yangsan-si	Gyeongsangnam-do
New Zealand	Forest Investigative Site 526	Wellington
Poland	Forest Investigative Site 578	Gdansk
Poland	Forest Investigative Site 579	Gdansk
Poland	Forest Investigative Site 580	Kielce
Poland	Forest Investigative Site 576	Tyniec Maly
Poland	Forest Investigative Site 577	Warsaw
Serbia	Forest Investigative Site 626	Belgrade
Serbia	Forest Investigative Site 627	Belgrade
Serbia	Forest Investigative Site 629	Nis
Serbia	Forest Investigative Site 628	Novi Sad
South Africa	Forest Investigative Site 676	Bellville Cape Town
Spain	Forest Investigative Site 729	Barcelona
Spain	Forest Investigative Site 728	Sabadell
Spain	Forest Investigative Site 730	Torremolinos
Ukraine	Forest Investigative Site 803	Donetsk
Ukraine	Forest Investigative Site 807	Kharkiv
Ukraine	Forest Investigative Site 802	Kherson
Ukraine	Forest Investigative Site 804	Kyiv
Ukraine	Forest Investigative Site 801	Odessa
United States	Forest Investigative Site 081	Albuquerque	New Mexico
United States	Forest Investigative Site 107	Albuquerque	New Mexico
United States	Forest Investigative Site 069	Avon Lake	Ohio
United States	Forest Investigative Site 071	Bothell	Washington
United States	Forest Investigative Site 078	Boulder	Colorado
United States	Forest Investigative Site 075	Bradenton	Florida
United States	Forest Investigative Site 098	Bronx	New York
United States	Forest Investigative Site 073	Centennial	Colorado
United States	Forest Investigative Site 072	Chapel Hill	North Carolina
United States	Forest Investigative Site 105	Charleston	South Carolina
United States	Forest Investigative Site 119	Charleston	West Virginia
United States	Forest Investigative Site 064	Charlottesville	Virginia
United States	Forest Investigative Site 028	Clinton	Utah
United States	Forest Investigative Site 001	Columbus	Ohio
United States	Forest Investigative Site 068	Dothan	Alabama
United States	Forest Investigative Site 082	Evansville	Indiana
United States	Forest Investigative Site 123	Fort Wayne	Indiana
United States	Forest Investigative Site 080	Gainesville	Florida
United States	Forest Investigative Site 054	Glendale	California
United States	Forest Investigative Site 053	Gresham	Oregon
United States	Forest Investigative Site 130	Henderson	Nevada
United States	Forest Investigative Site 051	Houston	Texas
United States	Forest Investigative Site 109	Imperial	California
United States	Forest Investigative Site 056	Indianapolis	Indiana
United States	Forest Investigative Site 066	Irvine	California
United States	Forest Investigative Site 117	Jacksonville	Florida
United States	Forest Investigative Site 132	Johnstown	Pennsylvania
United States	Forest Investigative Site 095	Lake Charles	Louisiana
United States	Forest Investigative Site 104	Las Vegas	Nevada
United States	Forest Investigative Site 102	Libertyville	Illinois
United States	Forest Investigative Site 097	Lincoln	Nebraska
United States	Forest Investigative Site 116	Lincoln	Nebraska
United States	Forest Investigative Site 077	Little Rock	Arkansas
United States	Forest Investigative Site 096	Los Angeles	California
United States	Forest Investigative Site 061	Louisville	Kentucky
United States	Forest Investigative Site 065	Maitland	Florida
United States	Forest Investigative Site 131	McMurray	Pennsylvania
United States	Forest Investigative Site 100	Media	Pennsylvania
United States	Forest Investigative Site 090	Memphis	Tennessee
United States	Forest Investigative Site 118	Miami	Florida
United States	Forest Investigative Site 063	Middleton	Wisconsin
United States	Forest Investigative Site 023	Naperville	Illinois
United States	Forest Investigative Site 057	Nashville	Tennessee
United States	Forest Investigative Site 136	Neptune	New Jersey
United States	Forest Investigative Site 091	New Orleans	Louisiana
United States	Forest Investigative Site 059	Newton	Massachusetts
United States	Forest Investigative Site 113	Norfolk	Virginia
United States	Forest Investigative Site 085	Oakland Park	Florida
United States	Forest Investigative Site 141	Ogden	Utah
United States	Forest Investigative Site 019	Oklahoma City	Oklahoma
United States	Forest Investigative Site 115	Orange City	Florida
United States	Forest Investigative Site 062	Orlando	Florida
United States	Forest Investigative Site 125	Orlando	Florida
United States	Forest Investigative Site 005	Phoenix	Arizona
United States	Forest Investigative Site 124	Roanoke	Virginia
United States	Forest Investigative Site 086	Rockville	Maryland
United States	Forest Investigative Site 029	Salt Lake City	Utah
United States	Forest Investigative Site 021	San Francisco	California
United States	Forest Investigative Site 026	Santa Ana	California
United States	Forest Investigative Site 108	Springfield	Massachusetts
United States	Forest Investigative Site 002	Stanford	California
United States	Forest Investigative Site 067	Tampa	Florida
United States	Forest Investigative Site 070	The Woodlands	Texas
United States	Forest Investigative Site 127	Toms River	New Jersey
United States	Forest Investigative Site 055	Tucson	Arizona
United States	Forest Investigative Site 092	Tulsa	Oklahoma
United States	Forest Investigative Site 052	Washington	District of Columbia
United States	Forest Investigative Site 101	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Forest Laboratories

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Colombia,  Estonia,  France,  Hungary,  Iceland,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Serbia,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients With Any Treatment-emergent Adverse Event	Number of patients who experienced 1 or more Treatment Emergent Adverse Event	Visit 1 (Week 0) up to 30 days after Visit 8 (up to Week 48) or Final Visit	Yes