Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

NCT ID: NCT00584948

Last Updated: 2017-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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Conditions

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Fragile X-Associated Tremor/Ataxia Syndrome Fragile X Premutation Carriers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Memantine

Group Type EXPERIMENTAL

Memantine

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Placebo

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.

Intervention Type DRUG

Other Intervention Names

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Namenda

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Previous reaction to memantine
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Randi J Hagerman, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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UC Davis MIND Institute

Sacramento, California, United States

Site Status

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24345444 (View on PubMed)

Other Identifiers

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1RL1AG032115-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200715426-1

Identifier Type: -

Identifier Source: org_study_id

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