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

PHASE2TerminatedINTERVENTIONAL
Enrollment

747

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

March 31, 2014

Conditions
Autism Spectrum Disorder (ASD)AutismAutistic DisorderAsperger's DisorderAsperger'sPediatric AutismPervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Interventions
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."

Trial Locations (106)

200

Forest Investigative Site 401, Kopavogur

1020

Forest Investigative Site 204, Brussels

1026

Forest Investigative Site 381, Budapest

1083

Forest Investigative Site 376, Budapest

1089

Forest Investigative Site 378, Budapest

1090

Forest Investigative Site 203, Jette

4080

Forest Investigative Site 804, Kyiv

5700

Forest Investigative Site 382, Gyula

7530

Forest Investigative Site 676, Bellville Cape Town

7902

Forest Investigative Site 526, Wellington

10467

Forest Investigative Site 098, The Bronx

10617

Forest Investigative Site 276, Tallinn

11000

Forest Investigative Site 626, Belgrade

Forest Investigative Site 627, Belgrade

15317

Forest Investigative Site 131, McMurray

15904

Forest Investigative Site 132, Johnstown

18000

Forest Investigative Site 629, Niš

19063

Forest Investigative Site 100, Media

20852

Forest Investigative Site 086, Rockville

21000

Forest Investigative Site 628, Novi Sad

22903

Forest Investigative Site 064, Charlottesville

23507

Forest Investigative Site 113, Norfolk

24014

Forest Investigative Site 124, Roanoke

25304

Forest Investigative Site 119, Charleston

25317

Forest Investigative Site 580, Kielce

27514

Forest Investigative Site 072, Chapel Hill

29407

Forest Investigative Site 105, Charleston

29620

Forest Investigative Site 730, Torremolinos

32216

Forest Investigative Site 117, Jacksonville

32607

Forest Investigative Site 080, Gainesville

32751

Forest Investigative Site 075, Bradenton

Forest Investigative Site 065, Maitland

32763

Forest Investigative Site 115, Orange City

32803

Forest Investigative Site 125, Orlando

32806

Forest Investigative Site 062, Orlando

33155

Forest Investigative Site 118, Miami

33334

Forest Investigative Site 085, Oakland Park

33414

Forest Investigative Site 101, Wellington

33613

Forest Investigative Site 067, Tampa

36303

Forest Investigative Site 068, Dothan

37232

Forest Investigative Site 057, Nashville

38119

Forest Investigative Site 090, Memphis

40202

Forest Investigative Site 061, Louisville

43210

Forest Investigative Site 001, Columbus

44012

Forest Investigative Site 069, Avon Lake

46260

Forest Investigative Site 056, Indianapolis

46805

Forest Investigative Site 123, Fort Wayne

47713

Forest Investigative Site 082, Evansville

53100

Forest Investigative Site 452, Siena

53562

Forest Investigative Site 063, Middleton

55040

Forest Investigative Site 576, Tyniec Mały

60048

Forest Investigative Site 102, Libertyville

60563

Forest Investigative Site 023, Naperville

61153

Forest Investigative Site 807, Kharkiv

65014

Forest Investigative Site 801, Odesa

68516

Forest Investigative Site 116, Lincoln

68526

Forest Investigative Site 097, Lincoln

69500

Forest Investigative Site 329, Bron

70112

Forest Investigative Site 091, New Orleans

70605

Forest Investigative Site 095, Lake Charles

73116

Forest Investigative Site 019, Oklahoma City

73488

Forest Investigative Site 802, Kherson

74104

Forest Investigative Site 092, Tulsa

77090

Forest Investigative Site 051, Houston

77381

Forest Investigative Site 070, The Woodlands

80112

Forest Investigative Site 073, Centennial

80214

Forest Investigative Site 577, Warsaw

80304

Forest Investigative Site 078, Boulder

80542

Forest Investigative Site 579, Gdansk

80952

Forest Investigative Site 578, Gdansk

83008

Forest Investigative Site 803, Donetsk

84015

Forest Investigative Site 028, Clinton

84106

Forest Investigative Site 029, Salt Lake City

84176

Forest Investigative Site 227, Barranquilla

84405

Forest Investigative Site 141, Ogden

85006

Forest Investigative Site 005, Phoenix

85718

Forest Investigative Site 055, Tucson

87109

Forest Investigative Site 107, Albuquerque

89052

Forest Investigative Site 130, Henderson

89128

Forest Investigative Site 104, Las Vegas

90024

Forest Investigative Site 096, Los Angeles

91206

Forest Investigative Site 054, Glendale

92251

Forest Investigative Site 109, Imperial

92612

Forest Investigative Site 066, Irvine

92701

Forest Investigative Site 026, Santa Ana

97030

Forest Investigative Site 053, Gresham

98011

Forest Investigative Site 071, Bothell

110744

Forest Investigative Site 702, Seoul

120752

Forest Investigative Site 703, Seoul

138736

Forest Investigative Site 701, Seoul

72202-3591

Forest Investigative Site 077, Little Rock

94143-0984

Forest Investigative Site 021, San Francisco

94305-5719

Forest Investigative Site 002, Stanford

20010-2970

Forest Investigative Site 052, Washington D.C.

02459

Forest Investigative Site 059, Newton

01199

Forest Investigative Site 108, Springfield

07753

Forest Investigative Site 136, Neptune City

08755

Forest Investigative Site 127, Toms River

87108-5129

Forest Investigative Site 081, Albuquerque

M5B 1T8

Forest Investigative Site 155, Toronto

Unknown

Forest Investigative Site 228, Antioquia

Forest Investigative Site 226, Bogotá

00165

Forest Investigative Site 453, Roma

626-770

Forest Investigative Site 704, Yangsan

08221

Forest Investigative Site 729, Barcelona

08208

Forest Investigative Site 728, Sabadell

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY