An interventional study of Memantine and Placebo in Fragile X-Associated Tremor/Ataxia Syndrome and Fragile X Premutation Carriers, sponsored by University of California, Davis. Completed at 2 sites in United States. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment
The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.
295 studies on the registry are indexed under Ataxia; 51 are open to participants now.
This study's enrollment of 94 is above the median of 26 across 216 interventional studies indexed under Ataxia.
Browse Ataxia studies →University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Memantine
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.
Also known as: Namenda
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.
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.
Time frame: 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
Time frame: 1 year
| Milestone | Memantine | Placebo |
|---|---|---|
| Started | 47 | 47 |
| Completed | 34 | 36 |
| Not completed | 13 | 11 |
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.
| units on a scale | Memantine | Placebo |
|---|---|---|
| Baseline | 17.44 ± 5.19 | 16.12 ± 5.43 |
| One Year | 15.66 ± 4.11 | 15.72 ± 3.93 |
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
| m/s^2 | Memantine | Placebo |
|---|---|---|
| Baseline | 1.31 ± 1.02 | 1.05 ± 0.73 |
| One Year | 1.77 ± 1.78 | 1.89 ± 2.19 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memantine | — | 2/47 (4.3%) | 6/47 (12.8%) |
| Placebo | — | 3/47 (6.4%) | 2/47 (4.3%) |
| Event | Memantine | Placebo |
|---|---|---|
| Motor Vehicle AccidentMusculoskeletal and connective tissue disorders | 1/47 | 0/47 |
| Lung CancerRespiratory, thoracic and mediastinal disorders | 1/47 | 0/47 |
| Ovarian CancerReproductive system and breast disorders | 0/47 | 1/47 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/47 | 1/47 |
| AppendicitisGastrointestinal disorders | 0/47 | 1/47 |
| Event | Memantine | Placebo |
|---|---|---|
| ConstipationGastrointestinal disorders | 6/47 | 2/47 |
| Age, Continuous(years) | Memantine | Placebo | Total |
|---|---|---|---|
| Mean | 64.7 ± 9.7 | 66.3 ± 7.0 | 65.5 ± 8.4 |
| Sex: Female, Male(Participants) | Memantine | Placebo | Total |
|---|---|---|---|
| Female | 15 | 19 | 34 |
| Male | 32 | 28 | 60 |
| Race (NIH/OMB)(Participants) | Memantine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 47 | 47 | 94 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Memantine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 |
| Not Hispanic or Latino | 46 | 43 | 89 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Memantine | Placebo | Total |
|---|---|---|---|
| United States | 47 | 47 | 94 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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University of California, Davis