Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 9:30 PM
Study NCT ID:
NCT01053156
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2010-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Minocycline to Treat Children With Fragile X Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005600', 'term': 'Fragile X Syndrome'}, {'id': 'C562573', 'term': 'cyclopia sequence'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'randi.hagerman@ucdmc.ucdavis.edu', 'phone': '916-703-0247', 'title': 'Randi J. Hagerman MD, Medical Director of the MIND Institute', 'organization': 'MIND Institute, University of California Davis Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Results may be potentially biased by study design weaknesses, including unblinding of subjects when they completed the study, drug-related side effects unblinding and preliminary efficacy analysis results known to investigators.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.', 'otherNumAtRisk': 66, 'otherNumAffected': 53, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.', 'otherNumAtRisk': 66, 'otherNumAffected': 53, 'seriousNumAtRisk': 66, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Upset/ Vomiting/Loss of Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Rash/ Itching/ Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever/Chills/URI/Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sunburn/Sun Sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased agitation, aggression, tantrums, uncooperative, irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blue-grey/Grey hue to teeth or other tissues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Seizure', 'notes': 'The patient was on placebo when this occurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Global Impression Scale (CGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.49', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '3 months (post first treatment) and 6 months (post second treatment)', 'description': 'The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 "very much improved" to 7 "very much worse". Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Any participant who completed at least the first arm of the trial were included in the intention to treat analysis'}, {'type': 'PRIMARY', 'title': 'Visual Analogue Scale- Behavior 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.28', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '4.44', 'spread': '0.30', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the first behavior that the caregivers noted, out of three.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Any participant who completed at least the first arm of the trial were included in the intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale- Behaviors 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.62', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '4.91', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '4.16', 'spread': '0.29', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the second behavior that the caregivers noted, out of three.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Expressive Vocabulary Test-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.92', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '68.86', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '67.91', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': "The EVT-2 standard score assesses language development through a participant's one word synonym response to visual stimuli. Standard scores range from 20-160. A standard score of 100 is average, with a 15 point standard deviation. Higher values represent a better outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.88', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '70.85', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '71.43', 'spread': '0.90', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'The VABS-II Adaptive Behavior Composite Score was used to assess adaptive skills. An Adaptive Behavior Composite Score may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.22', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '44.22', 'spread': '3.02', 'groupId': 'OG001'}, {'value': '41.81', 'spread': '2.94', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': "The ABC-C composite scores were used to quantify the severity of a patient's behaviors. A composite score consists of subscale scores including Irritability and Agitation, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity and Noncompliance, and Inappropriate Speech. The composite score may range from 0-174. Lower scores indicate improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale Behavior 3- VAS3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.80', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '4.88', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '4.13', 'spread': '0.35', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the third behavior that caregivers noted, out of three.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'This behavior was not provided by all of the participating caregivers, and so the number is less than the participants analyzed for other measures.'}, {'type': 'SECONDARY', 'title': 'VAS Categorized by Behavior: Aggression/ ADHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '4.26', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with aggression or ADHD behaviors.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding ADHD or Aggression symptoms were placed into this category. As not every caregiver named a behavior related to ADHD or aggression, this number is less than the number of participants.'}, {'type': 'SECONDARY', 'title': 'VAS Categorized by Behavior:Anxiety/ Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.47', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '5.26', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '4.05', 'spread': '0.46', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with anxiety or mood related behaviors.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding anxiety or mood symptoms were placed into this category. As not every caregiver named a behavior related to anxiety or mood, this number is less than the number of participants.'}, {'type': 'SECONDARY', 'title': 'VAS Categorized by Behavior:Language/ Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '4.67', 'spread': '0.34', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with language or cognitive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors regarding language or cognition symptoms were placed into this category. As not every caregiver named a behavior related to language or cognition, this number is less than the number of participants.'}, {'type': 'SECONDARY', 'title': 'VAS Categorized by Behavior: Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Prior to any intervention being started.'}, {'id': 'OG001', 'title': 'Minocycline', 'description': 'Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing \\>45 kg receiving 100 mg once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.49', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '5.84', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '3.41', 'spread': '0.54', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with other behaviors that were not able to be categorized.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'In this ad hoc analysis, the various behaviors captured on the VAS were categorized and any behaviors not falling into the other categories were placed into this category. As not every caregiver named a behavior unrelated to the other categories, this number is less than the number of participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Minocycline First, Then Placebo Second', 'description': 'Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.'}, {'id': 'FG001', 'title': 'Placebo First, Minocycline Second', 'description': 'Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months'}], 'periods': [{'title': 'First Intervention (Week 1-12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Second Intervention (Week 13-24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Recruitment occurred from January 2010 to June 2011, with the last participants completing the study in December 2011. The study site was a single site, the MIND Institute at the University of California Davis Medical Center.', 'preAssignmentDetails': 'Inclusion criteria: FXS confirmed by FMR1 DNA, age 3.5-16 years and stable pharmacological regimen \\> 4 weeks prior to study. Exclusion criteria:previous minocycline treatment, plans to change pharmacological intervention or allergy to tetracyclines. 66 patients enrolled; 55 patients with any data on outcome measures analyzed (11 withdrawn).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Minocycline First, Placebo Second', 'description': 'Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.'}, {'id': 'BG001', 'title': 'Placebo First, Minocycline Second', 'description': 'Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.01', 'spread': '3.76', 'groupId': 'BG000'}, {'value': '9.4', 'spread': '3.39', 'groupId': 'BG001'}, {'value': '9.21', 'spread': '3.57', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The baseline participants are different in number from those started in the participant flow module because in our intent to treat analysis, only those who completed one or more treatment periods were included in the analysis.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-25', 'studyFirstSubmitDate': '2010-01-19', 'resultsFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-06-30', 'studyFirstPostDateStruct': {'date': '2010-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression Scale (CGI)', 'timeFrame': '3 months (post first treatment) and 6 months (post second treatment)', 'description': 'The CGI-I utilizes history from primary caregivers and incorporates it into a seven step clinical rating for follow up throughout treatment, from 1 "very much improved" to 7 "very much worse". Lower scores indicate more improvement. Scores were obtained post treatments. Scores from when the patients were on minocycline either first or second were combined and averaged to determine a least squares mean and placebo scores were obtained in the same manner.'}, {'measure': 'Visual Analogue Scale- Behavior 1', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the first behavior that the caregivers noted, out of three.'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale- Behaviors 2', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the second behavior that the caregivers noted, out of three.'}, {'measure': 'Expressive Vocabulary Test-2', 'timeFrame': 'Baseline, 3 months and 6 months', 'description': "The EVT-2 standard score assesses language development through a participant's one word synonym response to visual stimuli. Standard scores range from 20-160. A standard score of 100 is average, with a 15 point standard deviation. Higher values represent a better outcome."}, {'measure': 'Vineland Adaptive Behavior Scale-II (VABS-II)Adaptive Behavior Composite Score', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': 'The VABS-II Adaptive Behavior Composite Score was used to assess adaptive skills. An Adaptive Behavior Composite Score may range from 20-160 with an average of 100 with a standard deviation of 15. Higher scores show improvement.'}, {'measure': 'Aberrant Behavior Checklist-Community Edition (ABC-C)Composite Score', 'timeFrame': 'Baseline, 3 months, and 6 months', 'description': "The ABC-C composite scores were used to quantify the severity of a patient's behaviors. A composite score consists of subscale scores including Irritability and Agitation, Lethargy and Social Withdrawal, Stereotypic Behavior, Hyperactivity and Noncompliance, and Inappropriate Speech. The composite score may range from 0-174. Lower scores indicate improvement."}, {'measure': 'Visual Analogue Scale Behavior 3- VAS3', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the third behavior that caregivers noted, out of three.'}, {'measure': 'VAS Categorized by Behavior: Aggression/ ADHD', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with aggression or ADHD behaviors.'}, {'measure': 'VAS Categorized by Behavior:Anxiety/ Mood', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with anxiety or mood related behaviors.'}, {'measure': 'VAS Categorized by Behavior:Language/ Cognition', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with language or cognitive symptoms.'}, {'measure': 'VAS Categorized by Behavior: Other', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'A VAS is used to represent a caregiver\'s assessment of given behaviors, which were chosen by the parents. Caregivers marked a 10 cm horizontal line representing a visual continuum of each behavior from "worst behavior" to "behavior not a problem." Greater values indicate greater improvement. This measure represents the least squares mean of all behaviors having to do with other behaviors that were not able to be categorized.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fragile X syndrome', 'minocycline', 'targeted treatment'], 'conditions': ['Fragile X Syndrome']}, 'referencesModule': {'references': [{'pmid': '18835858', 'type': 'BACKGROUND', 'citation': 'Bilousova TV, Dansie L, Ngo M, Aye J, Charles JR, Ethell DW, Ethell IM. Minocycline promotes dendritic spine maturation and improves behavioural performance in the fragile X mouse model. J Med Genet. 2009 Feb;46(2):94-102. doi: 10.1136/jmg.2008.061796. Epub 2008 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. We are investigating its use in FXS because it lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also strengthens brain connections in the animal models of FXS. We hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile X patients.', 'detailedDescription': 'This is a single center study at the UC Davis MIND Institute in patients age 3.5-16 years of age with fragile X syndrome (FXS), funded by a National Fragile X Foundation Grant. It is a controlled trial of minocycline, an antibiotic commonly used in children for infection or for treatment of neurodegenerative disorders. We are investigating its use in FXS because it lowers matrix metalloproteinase 9 (MMP9) levels, which are high in FXS, and it also strengthens brain connections in the animal models of FXS. We hypothesize that minocycline will likely be helpful for language, behavior and/or cognition in fragile X patients.\n\nThe aim of this study is to carry out a double-blind placebo controlled trial of minocycline treatment in children with FXS who are 3.5 to 16 years of age. At baseline, we will assess behavior and perceptual and cognitive development. After the children have been treated for 3 months with either minocycline or placebo, they undergo the same baseline testing. They will then cross over and be treated for a second 3 months. We will carry out testing again at the end of the second 3 month period. We will also assess the side effects of minocycline treatment throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '42 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have fragile X syndrome with molecular documentation\n* Current pharmacological treatment regimen has been stable for at least 4 weeks\n\nExclusion Criteria:\n\n* Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study\n* subjects who are unable to take oral medication\n* subjects who have been on minocycline previously\n* subjects who are allergic to minocycline or tetracyclines\n* subjects who are pregnant\n* subjects with history of lupus or hepatic dysfunction'}, 'identificationModule': {'nctId': 'NCT01053156', 'briefTitle': 'Trial of Minocycline to Treat Children With Fragile X Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Randomized Double-Blind Controlled Cross Over Trial of Minocycline in Children With Fragile X Syndrome', 'orgStudyIdInfo': {'id': '200917522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo pill', 'description': 'All patients will be on placebo for 3 months in this crossover study.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Minocycline', 'description': 'All patients will be on minocycline for 3 months in this crossover trial.', 'interventionNames': ['Drug: minocycline hydrochloride']}], 'interventions': [{'name': 'minocycline hydrochloride', 'type': 'DRUG', 'description': 'Minocycline hydrochloride dosed orally once a day for 3 months.', 'armGroupLabels': ['Minocycline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be given daily for 3 months.', 'armGroupLabels': ['Placebo pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'M.I.N.D. Institute at University of California at Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Randi J Hagerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.I.N.D. Institute at University of California at Davis, Sacramento CA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'The National Fragile X Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}