Trial · NCT00853580
A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1
NCT00853580, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2018-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1. Trials, record NCT00853580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00853580
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1
- NCT number
- NCT00853580
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 146 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Neurofibromatosis Type 1
- Interventions
- Lovastatin ™, placebo
- First posted
- 2009-03-02
- Last updated
- 2018-03-12
- Results first posted
- 2018-03-12
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery). | Baseline and Post-treatment (16 weeks) | A computerized test of visuospatial learning. Participants had to remember patterns associated with different locations on the screen, and during the test phase, as each pattern is presented, point to the appropriate location. The test starts at a very simple level and gradually increases in difficulty. Higher number of errors indicates poorer performance. Scale does not have a maximum range. |
| Primary | Score! (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Score! is a measure of sustained attention. Participants were required to silently count a series of aurally presented tones and say the total number of tones counted at the end of each trial. The number of tones ranged from 9 to 15, with a total of 10 trials (range 0-10). Higher values represent better performance. |
| Secondary | Spatial Working Memory (Cambridge Neuropsychological Test Automated Battery) | Baseline and Post-treatment (16 weeks) | A computerized measure of spatial working memory. This task assessed the participant's ability to retain spatial information and to manipulate remembered items in working memory. In this test, participants were shown an array of boxes on a computer screen and they were required to search through the boxes for hidden tokens. One box at a time was touched until a blue token was found inside. Participants then commenced a new search for the next token. The key instruction was that, once a token had been located, that box would not be used again to hide another token. Unit of measure was between search errors, determined by the number of boxes a participant reopens in which a token had previously been found. Higher score indicated poorer performance. Scale does not have a maximum range. |
| Secondary | Stockings of Cambridge (Cambridge Neuropsychological Test Automated Battery) Automated Battery). | Baseline and Post-treatment (16 weeks) | A computerized measure of spatial planning based on the "Tower of London" test. It required participants to move balls in a lower display to match a pattern shown in the upper display in a certain number of moves. More specifically, the participant was shown two displays containing three coloured balls. The displays were presented in such a way that they could be perceived as stacks of coloured balls held in socks suspended from a beam. The test administrator first demonstrated to the participant how to move the balls in the lower display to copy the pattern in the upper display and completed one demonstration problem, where the solution required one move. The participant then completed problems that increased in difficulty, from one through to five move problems. The unit of measure was the mean number of moves taken to complete a problem that could not be completed in less than five moves. The higher the score, the poorer the performance (range 5-12). |
| Secondary | Stop Signal Task (Cambridge Neuropsychological Test Automated Battery) | Baseline and Post-treatment (16 weeks) | A computerized measure of inhibitory control. The participant quickly responded to an arrow stimulus by pressing one of two buttons (left or right), depending on the direction in which the arrow pointed on the screen. If an audio tone is present, the subject was supposed to withhold the response. The difficulty of the task was manipulated by altering the delay before a stop signal (auditory tone) was presented, known as the stop signal delay. The outcome from this measure was stop signal reaction time (last half of test), which was computed by subtracting the mean stop signal delay at which the participant was able to stop on 50% of trials from the mean reaction time on go trials. Poorer response inhibition was reflected by a larger stop signal reaction time. Scale does not have a maximum range. |
| Secondary | Sky Search (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Sky Search is a measure of selective visual attention. Participants were presented with a A3 sheet with target stimuli (spaceships in identical pairs) randomly distributed among many distractors (spaceships in non-identical pairs). They were required to circle as many of the targets as possible as quickly as possible. The outcome measure (attention score), was a timing score reflecting the average time taken per target found. Higher scores represent poorer performance. Raw data are reported. Scale does not have a maximum range. |
| Secondary | Sky Search DT (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Sky Search DT is a test of divided attention. Children completed a parallel version of the Sky Search subtest while at the same time, silently counted the number of tones in a similar way to the Score! subtest. Higher scores represent poorer performance. Raw data are reported. Scale does not have a maximum range. |
| Secondary | Creature Counting (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Creature Counting is a measure of attentional control. Participants were required to count "creatures" from top of the page to the bottom, using arrows as cues to switch from counting up to counting down (and vice versa). There were seven testing trials. The outcome variable was the total number of correct trials (range 0-7). Higher scores represent better performances. |
| Secondary | Commission Errors (Conners Continuous Performance Test, Second Edition; CPT-II) | Baseline and Post-treatment (16 weeks) | A computerised measure of impulse control. Letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Commission errors represented the number of times a participant incorrectly responded to the non-target (letter 'X'). T-scores are reported, as generated by the test software. Higher scores indicate poorer performances. |
| Secondary | Omission Errors (Conners Continuous Performance Test, Second Edition; CPT-II) | Baseline and Post-treatment (16 weeks) | A computerised measure of vigilance and concentration. Letters were presented serially on a screen in a random order. All letters were considered target stimuli, except for the letter 'X' which is a non-target stimulus. Participants responded to target stimuli by pressing the space bar of a computer keyboard (90% of the stimuli) while withholding responses to non-target stimuli (10% of the test). Omission errors represented the number of times a participant fails to respond to target letters (all other than 'X'). T-scores are reported, as generated by the test software. Higher scores indicate poorer performances. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery). | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | PAL Total Errors | MEAN |
| PRIMARY | Score! (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | Units on a scale | MEAN |
| SECONDARY | Spatial Working Memory (Cambridge Neuropsychological Test Automated Battery) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | Errors | MEAN |
| SECONDARY | Stockings of Cambridge (Cambridge Neuropsychological Test Automated Battery) Automated Battery). | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | Moves | MEAN |
| SECONDARY | Stop Signal Task (Cambridge Neuropsychological Test Automated Battery) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | Milliseconds | MEAN |
| SECONDARY | Sky Search (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | Scores on a scale | MEAN |
| SECONDARY | Sky Search DT (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | Scores on a scale | MEAN |
| SECONDARY | Creature Counting (Test of Everyday Attention for Children) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | Scores on a scale | MEAN |
| SECONDARY | Commission Errors (Conners Continuous Performance Test, Second Edition; CPT-II) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | T score | MEAN |
| SECONDARY | Omission Errors (Conners Continuous Performance Test, Second Edition; CPT-II) | Baseline and Post-treatment (16 weeks) | Intention to treat using the modified intention-to-treat population (defined as all subjects that had baseline data). Missing post-treatment values were imputed using linear regression with age, sex and baseline values used as predictors (20 imputations). | T score | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group80
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery). | Lovastatin | Baseline | 15.8 | Standard Error 22.4 | PAL Total Errors |
| Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery). | Placebo | Baseline | 17.0 | Standard Error 15.4 | PAL Total Errors |
| Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery). | Lovastatin | Post-treatment | 10.3 | Standard Error 8.4 | PAL Total Errors |
| Paired Associate Learning (Cambridge Neuropsychological Test Automated Battery). | Placebo | Post-treatment | 11.7 | Standard Error 11.7 | PAL Total Errors |
| Score! (Test of Everyday Attention for Children) | Lovastatin | Baseline | 6.0 | Standard Deviation 2.0 | Units on a scale |
| Score! (Test of Everyday Attention for Children) | Placebo | Baseline | 5.7 | Standard Deviation 2.4 | Units on a scale |
| Score! (Test of Everyday Attention for Children) | Lovastatin | Post-treatment | 7.3 | Standard Deviation 2.1 | Units on a scale |
| Score! (Test of Everyday Attention for Children) | Placebo | Post-treatment | 6.8 | Standard Deviation 2.5 | Units on a scale |
| Spatial Working Memory (Cambridge Neuropsychological Test Automated Battery) | Lovastatin | Baseline | 47.0 | Standard Deviation 15.9 | Errors |
| Spatial Working Memory (Cambridge Neuropsychological Test Automated Battery) | Placebo | Baseline | 47.9 | Standard Deviation 16.2 | Errors |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lovastatin | 74 | |
| Overall Study | STARTED | Placebo | 72 | |
| Overall Study | COMPLETED | Lovastatin | 67 | |
| Overall Study | COMPLETED | Placebo | 56 | |
| Overall Study | NOT COMPLETED | Lovastatin | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | General | General disorders | Lovastatin | 29 | 74 | |
| other | General | General disorders | Placebo | 23 | 70 | |
| other | Cardiovascular | Cardiac disorders | Lovastatin | 7 | 74 | |
| other | Cardiovascular | Cardiac disorders | Placebo | 7 | 70 | |
| other | Gastrointestinal | Gastrointestinal disorders | Lovastatin | 33 | 74 | |
| other | Gastrointestinal | Gastrointestinal disorders | Placebo | 32 | 70 | |
| other | Hematologic | Blood and lymphatic system disorders | Lovastatin | 10 | 74 | |
| other | Hematologic | Blood and lymphatic system disorders | Placebo | 12 | 70 | |
| other | Hepatobiliary | Hepatobiliary disorders | Lovastatin | 3 | 74 | |
| other | Hepatobiliary | Hepatobiliary disorders | Placebo | 4 | 70 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lovastatin | 0 | 74 |
| Total, all-cause mortality | Placebo | 0 | 70 |
| Total, other adverse events | Lovastatin | 65 | 74 |
| Total, other adverse events | Placebo | 59 | 70 |
| Total, serious adverse events | Lovastatin | 6 | 74 |
| Total, serious adverse events | Placebo | 1 | 70 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27956565 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lovastatin vs Placebo: deaths from any cause | Trial comparisons |
| Lovastatin vs Placebo: serious adverse events | Trial comparisons |
Tests6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paired Associate Learning | Primary outcome | ConductCognition |
| Continuous Performance Test | Secondary outcome | ConductCognition |
| Line Angle Matching | Secondary outcome | ConductCognition |
| Stop-Signal Task | Secondary outcome | ConductCognition |
| Tower Planning | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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.
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