Trial · NCT01300923
Acamprosate in Youth With Fragile X Syndrome
NCT01300923, Phase 2, Completed, Indiana University; results first posted 2017-04-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acamprosate in Youth With Fragile X Syndrome. Trials, record NCT01300923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01300923
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acamprosate in Youth With Fragile X Syndrome
- NCT number
- NCT01300923
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Fragile X Syndrome, Autism Spectrum Disorders
- Interventions
- Acamprosate
- First posted
- 2011-02-23
- Last updated
- 2019-07-30
- Results first posted
- 2017-04-28
- Limitations and caveats
Psychophysiological measures proved non-feasible as subjects could not tolerate the procedures. The paradigms were tried on 2 subjects in the ADS arm, as data collected was not usable. Subsequently, neurobiological characterization was halted.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Global Impression- Severity Scale (CGI-S) | Week 10 | The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. |
| Secondary | The Aberrant Behavior Checklist (ABC) | Week 10 | The Aberrant Behavior Checklist (ABC) is a 58-item rating scale used to assess maladaptive behaviors across five original subscales: Irritability (15 items from 0-45), Social Withdrawal (16 items from 0-48), Stereotypy (7 items from 0-21), Hyperactivity (16 items from 0-48), Inappropriate Speech (4 items from 0-12). Additionally, Social Avoidance, a newly developed four-item subscale (from 0-12) of the ABC that captures core social avoidance aspects of Fragile X Syndrome is reported. All items on the ABC are rated from 0 (not at all a problem) to 3 (the problem is severe in degree). Higher scores indicate greater maladaptive behaviors. Differences between Baseline and Week 10 are used as an indicator of change. |
| Secondary | Social Responsiveness Scale | Week 10 | The 65-item SRS is a standardized measure of the core symptoms of autism. Each item is scored on a 4-point Likert scale. The score of each individual item is summed to create a total raw score. A total scores results are as follows: 0-62: Within normal limits 63-79: Mild range of impairment 80-108: Moderate range of impairment 109-149: Severe range of impairment |
| Secondary | Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD | Week 10 | The Children's Yale-Brown Obsessive Compulsive Scales-Modified (CY-BOCS) is a 5-item, semi-structured clinician rating scale modified designed to rate the current severity of repetitive behavior in children and adolescents with PDD. Once the current repetitive behaviors are identified, they are separately rated on 5 items: Time Spent, Interference, Distress, Resistance, and Control. Each of these items is scored on a 5-point scale form 0 (least symptomatic) to 4 (most symptomatic). The CY-BOCS yields a Total Score from 0 to 20 and is sensitive to change. |
| Secondary | ADHD Rating Scale 4th Edition | Week 10 | The ADHD Rating Scale is an 18-item scale directly derived from DSM-IV criteria for Attention Deficit Hyperactivity Disorder. The ADHD Rating Scale-IV is completed by the parent and scored by a clinician. The scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). If 3 or more items are skipped, the clinician should use extreme caution in interpreting the scale. The total score can range from 0 to 54, with a higher score indicating greater severity. |
| Secondary | Vineland Adaptive Behavior Scales-II (VABS-II) Communication Domain | Week 10 | The VABS-II is a semi-structured interview designed to assess adaptive functioning in communication, daily living, socialization and motor skills. Recognizing that language is a major area of impairment in the study population, the Communication Domain (99 Items from 0-198), in particular the Expressive Subdomain (54 Items from 0-108) are of interest in this study. Items arranged in a developmental sequence are rated on a 3-point scale. Each item is scored from 0 (never performs the behavior) to 3 (usually performs the behavior independently). Higher scores indicate higher adaptive functioning. Differences between Baseline and Week 10 are used as an indicator of change. |
| Secondary | Peabody Picture Vocabulary | Week 10 | The Peabody Picture Vocabulary Test is one of the most commonly used assessment tests that measure verbal ability in standard American English vocabulary. This test has been nationally standardized using examinees from various age groups, from children to adults. Thus, the raw scores are equated to mental age, using the norms obtained from standardization. The total standard scores range from 40 (worse receptive vocabulary) to 160 (better receptive vocabulary). The scores can also be converted to percentile rank. |
| Secondary | Brain-derived Neurotrophic Factor (BDNF) | Screen and Week 10 | BDNF is a protein that supports the survival of existing neurons and growth and differentiation of new neurons and synapses. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Global Impression- Severity Scale (CGI-S) | Week 10 | units on a scale | MEAN | |
| SECONDARY | The Aberrant Behavior Checklist (ABC) | Week 10 | units on a scale | MEAN | |
| SECONDARY | Social Responsiveness Scale | Week 10 | units on a scale | MEAN | |
| SECONDARY | Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD | Week 10 | units on a scale | MEAN | |
| SECONDARY | ADHD Rating Scale 4th Edition | Week 10 | units on a scale | MEAN | |
| SECONDARY | Vineland Adaptive Behavior Scales-II (VABS-II) Communication Domain | Week 10 | units on a scale | MEAN | |
| SECONDARY | Peabody Picture Vocabulary | Week 10 | units on a scale | MEAN | |
| SECONDARY | Brain-derived Neurotrophic Factor (BDNF) | Screen and Week 10 | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Global Impression- Severity Scale (CGI-S) | Acamprosate Treatment Group | 7.0 | Standard Deviation 8.9 | units on a scale | |
| The Aberrant Behavior Checklist (ABC) | Acamprosate Treatment Group | ABC Irritability | 7.0 | Standard Deviation 8.9 | units on a scale |
| The Aberrant Behavior Checklist (ABC) | Acamprosate Treatment Group | ABC Social Withdrawal | 4.1 | Standard Deviation 6.5 | units on a scale |
| The Aberrant Behavior Checklist (ABC) | Acamprosate Treatment Group | ABC Stereotypy | 6.0 | Standard Deviation 6.3 | units on a scale |
| The Aberrant Behavior Checklist (ABC) | Acamprosate Treatment Group | ABC Hyperactivity | 11.0 | Standard Deviation 8.6 | units on a scale |
| The Aberrant Behavior Checklist (ABC) | Acamprosate Treatment Group | ABC Inappropriate Speech | 4.8 | Standard Deviation 3.4 | units on a scale |
| The Aberrant Behavior Checklist (ABC) | Acamprosate Treatment Group | ABC Social Avoidance | 1.6 | Standard Deviation 2.7 | units on a scale |
| Social Responsiveness Scale | Acamprosate Treatment Group | 76.4 | Standard Deviation 26.8 | units on a scale | |
| Children's Yale-Brown Obsessive Compulsive Scale Modified for PDD | Acamprosate Treatment Group | 9.8 | Standard Deviation 4.1 | units on a scale | |
| ADHD Rating Scale 4th Edition | Acamprosate Treatment Group | 16.7 | Standard Deviation 8.0 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acamprosate | 12 | |
| Overall Study | STARTED | Autism Spectrum Disorder (ADS) | 2 | |
| Overall Study | COMPLETED | Acamprosate | 12 | |
| Overall Study | COMPLETED | Autism Spectrum Disorder (ADS) | 0 | |
| Overall Study | NOT COMPLETED | Acamprosate | 0 | |
| Overall Study | NOT COMPLETED | Autism Spectrum Disorder (ADS) | 2 |
Source ClinicalTrials.gov
Adverse events9
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 | Irritability | Psychiatric disorders | Acamprosate | 4 | 12 | 4 |
| other | Increased repetitive behavior | Psychiatric disorders | Acamprosate | 2 | 12 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Acamprosate | 1 | 12 | 1 |
| other | mild constipation | Gastrointestinal disorders | Acamprosate | 1 | 12 | 1 |
| other | Increased anxiety | Psychiatric disorders | Acamprosate | 1 | 12 | 1 |
| other | Insomnia | Psychiatric disorders | Acamprosate | 1 | 12 | 1 |
| other | Nightmares | Psychiatric disorders | Acamprosate | 1 | 12 | 1 |
| other | Rhinitis | Infections and infestations | Acamprosate | 1 | 12 | 1 |
| other | Urinary Urgency | Renal and urinary disorders | Acamprosate | 1 | 12 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acamprosate | ||
| Total, other adverse events | Acamprosate | 9 | 12 |
| Total, serious adverse events | Acamprosate | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23436129 | BACKGROUND |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
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 |
|---|---|
| Vocabulary Test | Secondary outcome |
Source 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.
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/NCT01300923
GET https://conductscience.org/api/trials/v1/NCT01300923/registered