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Trial · NCT00584948

Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

NCT00584948, Not applicable, Completed, University of California, Davis; results first posted 2017-04-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome. Trials, record NCT00584948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00584948

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome
NCT number
NCT00584948
Status
Completed
Phases
Not applicable
Enrollment
94 participants, actual
Lead sponsor
University of California, Davis
Conditions
Fragile X-Associated Tremor/Ataxia Syndrome, Fragile X Premutation Carriers
Interventions
Memantine, Placebo
First posted
2008-01-02
Last updated
2017-05-30
Results first posted
2017-04-10

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)One Year
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.
PrimaryChange From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale1 year
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

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)One Yearunits on a scaleMEAN
PRIMARYChange From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale1 yearm/s^2MEAN

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)MemantineBaseline17.44Standard Deviation 5.19units on a scale
Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)PlaceboBaseline16.12Standard Deviation 5.43units on a scale
Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)MemantineOne Year15.66Standard Deviation 4.11units on a scale
Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II)PlaceboOne Year15.72Standard Deviation 3.93units on a scale
Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor ScaleMemantineBaseline1.31Standard Deviation 1.02m/s^2
Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor ScalePlaceboBaseline1.05Standard Deviation 0.73m/s^2
Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor ScaleMemantineOne Year1.77Standard Deviation 1.78m/s^2
Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor ScalePlaceboOne Year1.89Standard Deviation 2.19m/s^2

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDMemantine47
Overall StudySTARTEDPlacebo47
Overall StudyCOMPLETEDMemantine34
Overall StudyCOMPLETEDPlacebo36
Overall StudyNOT COMPLETEDMemantine13
Overall StudyNOT COMPLETEDPlacebo11

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherConstipationGastrointestinal disordersMemantine64710
otherConstipationGastrointestinal disordersPlacebo2474
seriousMotor Vehicle AccidentMusculoskeletal and connective tissue disordersMemantine1471
seriousMotor Vehicle AccidentMusculoskeletal and connective tissue disordersPlacebo0470
seriousLung CancerRespiratory, thoracic and mediastinal disordersMemantine1471
seriousLung CancerRespiratory, thoracic and mediastinal disordersPlacebo0470
seriousOvarian CancerReproductive system and breast disordersMemantine0470
seriousOvarian CancerReproductive system and breast disordersPlacebo1471
seriousPneumoniaRespiratory, thoracic and mediastinal disordersMemantine0470
seriousPneumoniaRespiratory, thoracic and mediastinal disordersPlacebo1471

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityMemantine
Total, all-cause mortalityPlacebo
Total, other adverse eventsMemantine647
Total, other adverse eventsPlacebo247
Total, serious adverse eventsMemantine247
Total, serious adverse eventsPlacebo347

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
24345444DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
RL1AG032115Characterization and Treatment of CNS Abnormalities in Premutation Carriers (4 ofHAGERMAN, RANDI J.UNIVERSITY OF CALIFORNIA AT DAVISNATIONAL INSTITUTE ON AGING2007 to 2011

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Memantine vs Placebo: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00584948

GET https://conductscience.org/api/trials/v1/NCT00584948/registered