NCT00584948

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

5 years

First QC Date

December 22, 2007

Results QC Date

June 27, 2014

Last Update Submit

May 24, 2017

Conditions

Fragile X-Associated Tremor/Ataxia SyndromeFragile X Premutation Carriers

Keywords

FXTAS, Fragile X Premutation

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)

    The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance.

    One Year

  • Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale

    The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2

    1 year

Study Arms (2)

Memantine

EXPERIMENTAL
Drug: Memantine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MemantineDRUG

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.

Also known as: Namenda
Memantine
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5

You may not qualify if:

  • Previous reaction to memantine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC Davis MIND Institute

Sacramento, California, 95817, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

    PMID: 24345444DERIVED

MeSH Terms

Conditions

Fragile X Tremor Ataxia Syndrome

Interventions

Memantine

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Randi J Hagerman, MD
Organization
University of California, Davis Medical Center
randi.hagerman@ucdmc.ucdavis.edu
916-703-0247

Study Officials

  • Randi J Hagerman, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 2, 2008

Study Start

September 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 30, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-05

Locations

US(2)