Trial · NCT01531582
Minocycline in the Treatment of Angelman Syndrome
NCT01531582, Not applicable, Completed, University of South Florida; results first posted 2023-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Minocycline in the Treatment of Angelman Syndrome. Trials, record NCT01531582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01531582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Minocycline in the Treatment of Angelman Syndrome
- NCT number
- NCT01531582
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of South Florida
- Conditions
- Angelman Syndrome
- Interventions
- minocycline
- First posted
- 2012-02-13
- Last updated
- 2023-04-18
- Results first posted
- 2023-04-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 weeks & 16 weeks | The primary outcome measure consists of improvement in raw and standard scores on the Bayley Scales of Infant and Toddler Development when post Minocycline administration results are compared to baseline results. This is an individually administered test used to asses developmental functioning. The Bayley scales are typically used for ages 1-42 months, and can be utilized to identify developmental delay by evaluating five major areas of development: cognitive, communication, physical, social/emotional, and adaptive. The score ranges for each subscale are as follows: Cognitive, 0-91; Communication, 0-75; Receptive Language, 0-49; Expressive Language, 0-48; Gross Motor, 0-72; Fine Motor, 0-66; Self-Care, 0-72; and Self-Direction, 0-75. Fine and Gross Motor scores were summed for the Motor domain; Receptive and Expressive Language were combined for the Language domain. Increase in raw score indicates improvement in the specific subdomain for each of the listed scales. |
| Secondary | Normalization of the EEG (Electroencephalogram) Signature | Baseline, 8 and 16 weeks | A scoring system was used to evaluate several aspects of the EEG recordings regardless of whether or not they were a part of AS specific EEG patterns. Points were assigned when a particular characteristic was observed. For instance, when evaluating the EEG background, 1 point was assigned if primarily theta waves (mild slowing, \>50%) were observed. When a mixture of theta and delta waves (moderate slowing) were observed, 2 points were assigned. When primarily delta waves (severe slowing, \>50%) were recorded 3 points were assigned. Other EEG characteristics were also examined including occipital rhythm (normal-1, slow-2 and absent-3), rhythmic theta (present \<50% of time-1, present \>50% of time-2) rhythmic delta (present-3) and epileptiform abnormalities (present-1, focal-1, multifocal-1, generalized-1, seizure-2). The points were totaled resulting in a total score, ranging from 0 (most normal) to 24 (most abnormal). |
| Secondary | Vineland Adaptive Behavior Scale, 4th Edition (Vineland-II)Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 and 16 weeks | This test is to measure the adaptive behaviors; the ability to adapt to changes in one's environment, learn new everyday skills and level of independence. It measures social and personal skills via five major domains: communication, daily living skills, socialization, motor skills, and a maladaptive behavioral index. These scales can be used to support the diagnosis of intellectual and developmental disability. The score ranges for each subdomain are as follows: Receptive Communication, 0-108; Expressive Communication, 0-308; Fine Motor, 0-196; Gross Motor, 0-228; Personal Daily Living Skills, 0-268; Domestic Daily Living Skills, 0-184; Community Daily Living Skills, 0-348; Internalizing Maladaptive Behavior, 0-22; and Externalizing Maladaptive Behavior, 0-20. These raw scores are allocated into the five major domains, and standardized for analysis of results.Increase in raw score indicates improvement in the specific subdomain for each, except for Maladaptive Behavior Scales. |
| Secondary | Preschool Language Scale, Fourth Edition (PLS-4)Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 and 16 weeks | This test is used to evaluate the development of expressive and receptive language development. It also can be used to assess behaviors considered to be language precursors. The PLS use a play-based assessment to provide a comprehensive developmental language appraisal. These scales assess auditory and expressive comprehension. The score ranges for the two subdomains of this measure depend on 16 chronological age ranges from birth - 7 years, with a score range of 0-62 in Auditory Comprehension and 0-68 for Expressive Communication in a 7 year old. Minimum range: 50 (lower language abilities) Maximum range: 150 (higher language abilities). The PLS use a play-based assessment to provide a comprehensive developmental language appraisal. Increase in raw score indicates improvement in the specific subdomain. These raw scores are standardized for analysis and comparison. Standardization does not impact the interpretation of the results |
| Secondary | Clinical Global Impressions Severity Scale Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 & 16 weeks | The CGI is a brief assessment used by the clinician to describe the participants condition before and after the administration of a study medication.It is a research rating tool that physicians use to provide a timely assessment of a clinician's view of a particular patient's global functioning before and after the usage of a study medication. The CGI is used to measure the change since the initiation of treatment; both measures 10 questions on a seven-point Likert-type scale ranging from ranging from 1 to 7 points, equaling 10-70 points total, from which the mean is attained. A decrease in mean score indicates improvement in the specific sub-domain. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 weeks & 16 weeks | Scores on Scale | MEAN | |
| SECONDARY | Normalization of the EEG (Electroencephalogram) Signature | Baseline, 8 and 16 weeks | Score | MEAN | |
| SECONDARY | Vineland Adaptive Behavior Scale, 4th Edition (Vineland-II)Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 and 16 weeks | Scores on Scale | MEAN | |
| SECONDARY | Preschool Language Scale, Fourth Edition (PLS-4)Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 and 16 weeks | Scores on Scale | MEAN | |
| SECONDARY | Clinical Global Impressions Severity Scale Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline, 8 & 16 weeks | Scores on Scale | MEAN |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline Measures | Cognitive | 26.4 | Standard Deviation 2.48 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | 8 Weeks After Treatment With Minocycline | Cognitive | 31.7 | Standard Deviation 1.83 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | 16 Weeks-After 8 Week Washout | Cognitive | 30.7 | Standard Deviation 2.09 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline Measures | Communication | 18.9 | Standard Deviation 1.6 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | 8 Weeks After Treatment With Minocycline | Communication | 22.8 | Standard Deviation 1.69 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | 16 Weeks-After 8 Week Washout | Communication | 23.5 | Standard Deviation 1.88 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline Measures | Receptive Language | 13.4 | Standard Deviation 0.61 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | 8 Weeks After Treatment With Minocycline | Receptive Language | 13.7 | Standard Deviation 0.81 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | 16 Weeks-After 8 Week Washout | Receptive Language | 13.8 | Standard Deviation 0.68 | Scores on Scale |
| Bayley Scales of Infant and Toddler Development, 2nd Edition (BSID-II) Score at Baseline, 8 Weeks After Treatment, and at 16 Week Follow-up | Baseline Measures | Expressive Language | 10.1 | Standard Deviation 0.76 | Scores on Scale |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Children With Angelman Syndrome | 25 | |
| Overall Study | COMPLETED | Children With Angelman Syndrome | 24 | |
| Overall Study | NOT COMPLETED | Children With Angelman Syndrome | 1 |
Source ClinicalTrials.gov
Adverse events8
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 | Lethargy/Sleepiness | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 2 | 25 | |
| other | Difficulty Ambulating | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 2 | 25 | |
| other | Darkening/discoloration over the anterior tibia | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 1 | 25 | |
| other | Commencement of Menstruation | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 1 | 25 | |
| other | Urinary Tract Infection | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 1 | 25 | |
| other | Influenza Type A | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 1 | 25 | |
| other | Feminine yeast Infection | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 1 | 25 | |
| serious | Seizure | Congenital, familial and genetic disorders | Children With Angelman Syndrome Receiving Minocycline | 3 | 25 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Children With Angelman Syndrome Receiving Minocycline | ||
| Total, other adverse events | Children With Angelman Syndrome Receiving Minocycline | 9 | 25 |
| Total, serious adverse events | Children With Angelman Syndrome Receiving Minocycline | 3 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25491305 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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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