Trial · NCT00858689
Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome
NCT00858689, Not applicable, Completed, FRAXA Research Foundation; results first posted 2016-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome. Trials, record NCT00858689. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00858689
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Add-on Pilot Trial of Minocycline to Treat Fragile X Syndrome
- NCT number
- NCT00858689
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 20 participants, actual
- Lead sponsor
- FRAXA Research Foundation
- Conditions
- Fragile X Syndrome
- Interventions
- Minocycline
- First posted
- 2009-03-10
- Last updated
- 2016-02-18
- Results first posted
- 2016-02-18
- Limitations and caveats
- This was an open-label trial. Further study in a randomized controlled trial is warranted.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of ABC Irritability Subtest Score at 8 Weeks | Baseline and 8 weeks | The 15-item Irritability Scale includes questions about aggression, self-injury, tantrums, agitation, and unstable mood on a scale of 0 to 45 with higher scores indicating greater severity. This scale has been successfully used in previous medication studies in children with autism and in patients with FXS and in a controlled trial of ampakine CX516 in FXS. All ABC subscales showed good reliability when used by parents and caregivers of individuals with FXS to assess behavior in the CX516 study NCT00054730, and yielded intraclass correlation coefficient (ICC) values of 0.7-0.9. |
| Primary | ABC Irritability Subtest Score | 8 weeks | ABC Irritability subtest score was used |
| Primary | ABC Irritability Subtest Score | 1 year | ABC (Aberrant behavior checklist) Irritability subtest score was used |
| Secondary | Parent Defined Target Symptoms Scale-Visual | Baseline | |
| Secondary | Clinical Global Impression Scale | Baseline | |
| Secondary | Stanford Binet 5 (SB5) | Baseline | |
| Secondary | The Peabody Picture Vocabulary Test Third Edition (PPVT-III) | Baseline | |
| Secondary | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Baseline | |
| Secondary | Non-Verbal Associative Learning Task (NVALT) | Baseline | |
| Secondary | Vineland Adaptive Behaviour Scales (VABS) | Baseline |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of ABC Irritability Subtest Score at 8 Weeks | Baseline and 8 weeks | ABC-I change in subjects completing 8 weeks of minocycline treatment | units on a scale | MEAN |
| PRIMARY | ABC Irritability Subtest Score | 8 weeks | completed 8 weeks of minocycline treatment | units on a scale | MEAN |
| PRIMARY | ABC Irritability Subtest Score | 1 year | |||
| SECONDARY | Parent Defined Target Symptoms Scale-Visual | Baseline | |||
| SECONDARY | Clinical Global Impression Scale | Baseline | |||
| SECONDARY | Stanford Binet 5 (SB5) | Baseline | |||
| SECONDARY | The Peabody Picture Vocabulary Test Third Edition (PPVT-III) | Baseline | |||
| SECONDARY | The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Baseline | |||
| SECONDARY | Non-Verbal Associative Learning Task (NVALT) | Baseline | |||
| SECONDARY | Vineland Adaptive Behaviour Scales (VABS) | Baseline |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of ABC Irritability Subtest Score at 8 Weeks | Minocyline 50 mg or 100 mg PO BID | -14.37 | Standard Deviation 7.84 | units on a scale | |
| ABC Irritability Subtest Score | Minocyline 50 mg or 100 mg PO BID | 7.74 | Standard Deviation 4.82 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Minocyline 50 mg or 100 mg PO BID | 20 | |
| Overall Study | COMPLETED | Minocyline 50 mg or 100 mg PO BID | 19 | |
| Overall Study | NOT COMPLETED | Minocyline 50 mg or 100 mg PO BID | 1 |
Source ClinicalTrials.gov
Adverse events1
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 | Increased serum ANA titre | Immune system disorders | Minocyline 50 mg or 100 mg PO BID | 2 | 20 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Minocyline 50 mg or 100 mg PO BID | ||
| Total, other adverse events | Minocyline 50 mg or 100 mg PO BID | 2 | 20 |
| Total, serious adverse events | Minocyline 50 mg or 100 mg PO BID | 0 | 20 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20937127 | RESULT |
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/NCT00858689
GET https://conductscience.org/api/trials/v1/NCT00858689/registered?page=2