Trial record 1 of 1 for:    00584948
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Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of California, Davis.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Forest Laboratories
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584948
First received: December 22, 2007
Last updated: June 25, 2010
Last verified: June 2010

December 22, 2007
June 25, 2010
September 2007
September 2012   (final data collection date for primary outcome measure)
Improvement in neurocognitive functioning [ Time Frame: One Year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00584948 on ClinicalTrials.gov Archive Site
Improvement in Cognitive ERP Deficits [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome
Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine

The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fragile X-Associated Tremor/Ataxia Syndrome
  • Fragile X Premutation Carriers
Drug: Memantine
Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.
Other Name: Namenda
Not Provided
Seritan AL, Nguyen DV, Mu Y, Tassone F, Bourgeois JA, Schneider A, Cogswell JB, Cook KR, Leehey MA, Grigsby J, Olichney JM, Adams PE, Legg W, Zhang L, Hagerman PJ, Hagerman RJ. Memantine for fragile X-associated tremor/ataxia syndrome: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2014 Mar;75(3):264-71. doi: 10.4088/JCP.13m08546.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms

Exclusion Criteria:

  • Previous reaction to memantine
Both
30 Years and older
Yes
Contact: Jennifer B Cogswell 916-703-0331 jennifer.cogswell@ucdmc.ucdavis.edu
Contact: Louise Gane 916-703-0238 louise.gane@ucdmc.ucdavis.edu
United States
 
NCT00584948
200715426-1, 1 RL1 AG032115-01
Yes
Randi J. Hagerman, M.D., University of California, Davis
University of California, Davis
  • National Institute on Aging (NIA)
  • Forest Laboratories
Principal Investigator: Randi J Hagerman, MD University of California, Davis
University of California, Davis
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP