Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT02998151
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Neurophysiological and Acute Pharmacological Studies in FXS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005600', 'term': 'Fragile X Syndrome'}], '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': 'D000077443', 'term': 'Acamprosate'}, {'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D008911', 'term': 'Minocycline'}, {'id': 'D001418', 'term': 'Baclofen'}], 'ancestors': [{'id': 'D013654', 'term': 'Taurine'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'craig.erickson@cchmc.org', 'phone': '513-636-0523', 'title': 'Dr. Craig Erickson', 'organization': "Cincinnati Children's Hospital Medical Center"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected up to four weeks after the final dosing visit.', 'description': 'Participants were asked about adverse events in person 4 hours after each dose and at the end of each dosing visit, and via phone calls conducted one day after and 8 days after each dosing visit. Additionally, participants were contacted by phone 4 weeks after the final dosing visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo: placebo pill', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acamprosate', 'description': 'Acamprosate: two 666mg pills', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lovastatin', 'description': 'Lovastatin: two 20mg pills', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 4, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Minocycline', 'description': 'Minocycline: two 135mg pills', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 4, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Baclofen', 'description': 'Baclofen: one 30mg pill', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Mania', 'notes': 'excessive talking or hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in EEG Relative Gamma Power', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: placebo pill'}, {'id': 'OG001', 'title': 'Acamprosate', 'description': 'Acamprosate: two 666mg pills'}, {'id': 'OG002', 'title': 'Lovastatin', 'description': 'Lovastatin: two 20mg pills'}, {'id': 'OG003', 'title': 'Minocycline', 'description': 'Minocycline: two 135mg pills'}, {'id': 'OG004', 'title': 'Baclofen', 'description': 'Baclofen: one 30mg pill'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0024', 'spread': '.0265', 'groupId': 'OG000'}, {'value': '-0.0077', 'spread': '0.0252', 'groupId': 'OG001'}, {'value': '-0.0039', 'spread': '0.0225', 'groupId': 'OG002'}, {'value': '0.0019', 'spread': '0.0235', 'groupId': 'OG003'}, {'value': '-0.0160', 'spread': '0.0346', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 4-hour post-dose', 'description': 'EEG relative gamma power at rest was calculated as the percent of power in the gamma frequencies relative to the sum of power in all frequency bands, averaged across electrodes, and calculated separately at pre-dose and post-dose timepoints. To assess the impact of drug, the pre-dose relative gamma power was subtracted from post-dose relative gamma power. Higher numbers indicate more relative gamma power post-dose; lower numbers indicate more relative gamma power pre-dose.', 'unitOfMeasure': 'percent of power in gamma frequencies', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing 1 placebo, 1 lovastatin who contributed data with excessive movement or other artifact, or were unable to complete the task.'}, {'type': 'PRIMARY', 'title': 'Clinical Global Impressions-Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: placebo pill'}, {'id': 'OG001', 'title': 'Acamprosate', 'description': 'Acamprosate: two 666mg pills'}, {'id': 'OG002', 'title': 'Lovastatin', 'description': 'Lovastatin: two 20mg pills'}, {'id': 'OG003', 'title': 'Minocycline', 'description': 'Minocycline: two 135mg pills'}, {'id': 'OG004', 'title': 'Baclofen', 'description': 'Baclofen: one 30mg pill'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '.61', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '.62', 'groupId': 'OG001'}, {'value': '3.97', 'spread': '.50', 'groupId': 'OG002'}, {'value': '3.81', 'spread': '.49', 'groupId': 'OG003'}, {'value': '3.94', 'spread': '.43', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hour post-dose', 'description': "The Clinical Global Impressions - Improvement (CGI-I) requires the clinician to assess how much the patient's illness has changed relative to pre-dose, from 1 (very much improved) to 7 (very much worse).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'CGI-I was not collected for one participant on their minocycline day and another participant on their baclofen day.'}, {'type': 'SECONDARY', 'title': 'Woodcock Johnson Test of Cognitive Abilities - Auditory Attention Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: placebo pill'}, {'id': 'OG001', 'title': 'Acamprosate', 'description': 'Acamprosate: two 666mg pills'}, {'id': 'OG002', 'title': 'Lovastatin', 'description': 'Lovastatin: two 20mg pills'}, {'id': 'OG003', 'title': 'Minocycline', 'description': 'Minocycline: two 135mg pills'}, {'id': 'OG004', 'title': 'Baclofen', 'description': 'Baclofen: one 30mg pill'}], 'classes': [{'categories': [{'measurements': [{'value': '32.84', 'spread': '5.77', 'groupId': 'OG000'}, {'value': '33.07', 'spread': '5.48', 'groupId': 'OG001'}, {'value': '32.93', 'spread': '5.31', 'groupId': 'OG002'}, {'value': '33.24', 'spread': '6.04', 'groupId': 'OG003'}, {'value': '33', 'spread': '5.17', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4-hour post-dose', 'description': 'Woodcock Johnson Test of Cognitive Abilities III Auditory Attention subscale. Participants must identify orally presented words amid increasingly intense background noise. The scores for this subtask range from 0-50, with higher scores indicating a better outcome. Raw scores for this subscale are reported (rather than standard scores, or age- or grade-equivalents).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is missing from 2 placebo, 1 acamprosate, 1 lovastatin, 2 minocycline, and 1 baclofen.'}, {'type': 'SECONDARY', 'title': 'Change From Pre-dose in the Repeatable Battery for the Assessment of Neuropsychological Status at 4 Hours Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: placebo pill'}, {'id': 'OG001', 'title': 'Acamprosate', 'description': 'Acamprosate: two 666mg pills'}, {'id': 'OG002', 'title': 'Lovastatin', 'description': 'Lovastatin: two 20mg pills'}, {'id': 'OG003', 'title': 'Minocycline', 'description': 'Minocycline: two 135mg pills'}, {'id': 'OG004', 'title': 'Baclofen', 'description': 'Baclofen: one 30mg pill'}], 'classes': [{'categories': [{'measurements': [{'value': '-.20', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '5.17', 'groupId': 'OG001'}, {'value': '-1.25', 'spread': '3.85', 'groupId': 'OG002'}, {'value': '-.69', 'spread': '5.58', 'groupId': 'OG003'}, {'value': '-.88', 'spread': '3.35', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 4-hour post dose', 'description': 'Four 10-item lists of unrelated words were presented orally to the examinee who was then required to immediately recall words presented, at both pre-dose and post-dose timepoints. The impact of drug was assessed by subtracting the number of words remembered post-dose from the number of words remembered pre-dose. Lower numbers indicate more words remembered post-dose; higher numbers indicate more words remembered pre-dose.', 'unitOfMeasure': 'number of words remembered', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant is missing from placebo, acamprosate, lovastatin, and minocycline conditions due to being unable to repeat list words back to experimenter (nonverbal). Baclofen and placebo are each additionally missing one participant who did not complete the pre-dose or post-dose task.'}, {'type': 'SECONDARY', 'title': 'Test of Attentional Performance for Children (KiTAP) Test of Alertness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo: placebo pill'}, {'id': 'OG001', 'title': 'Acamprosate', 'description': 'Acamprosate: two 666mg pills'}, {'id': 'OG002', 'title': 'Lovastatin', 'description': 'Lovastatin: two 20mg pills'}, {'id': 'OG003', 'title': 'Minocycline', 'description': 'Minocycline: two 135mg pills'}, {'id': 'OG004', 'title': 'Baclofen', 'description': 'Baclofen: one 30mg pill'}], 'classes': [{'categories': [{'measurements': [{'value': '13.76', 'spread': '188.37', 'groupId': 'OG000'}, {'value': '-28.64', 'spread': '137.21', 'groupId': 'OG001'}, {'value': '18.59', 'spread': '169.39', 'groupId': 'OG002'}, {'value': '26.85', 'spread': '226.69', 'groupId': 'OG003'}, {'value': '-31.44', 'spread': '171.91', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Predose, 4-hour post-dose', 'description': 'Computerized task where an examinee is required to push a key when a target stimulus is presented on the screen. Scores are presented as change in median reaction time (RT), in milliseconds.', 'unitOfMeasure': 'change in median RT in milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant is missing from the placebo, acamprosate, lovastatin, and minocycline conditions due to being unable to participate in the task. An additional one participant each is missing from placebo, acamprosate, and lovastatin conditions due to uncollected data at either the pre-dose or post-dose timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'This study was designed as a 4-intervention crossover, with all study participants receiving all possible interventions. These were originally placebo, acamprosate, minocycline, and lovastatin. Midway through the study (n=16) it was determined that acamprosate was undetectable in serum and this arm was replaced by baclofen. Remaining participants (n=13) received baclofen and 5 participants were re-enrolled to receive baclofen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Placebo', 'achievements': [{'comment': 'Two participants withdrew from the study before receiving placebo.', 'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Acamprosate', 'comment': 'Acamprosate was discontinued due to undetectable serum levels after dosage.', 'achievements': [{'comment': "Every participant received acamprosate prior to acamprosate's discontinuance.", 'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Lovastatin', 'achievements': [{'comment': 'All participants received lovastatin.', 'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'Minocycline', 'achievements': [{'comment': 'Two participants withdrew from the study before receiving minocycline.', 'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Baclofen', 'comment': 'Baclofen replaced acamprosate after it was determined acamprosate was undetectable in serum after dosage.', 'achievements': [{'comment': 'All 13 remaining participants received baclofen after acamprosate was discontinued. Five participants were re-enrolled to receive baclofen.', 'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'comment': 'Five participants completed all 5 study arms; however, 26 completed all that were originally asked of them (4 visits, with 5 of those 26 re-enrolling to complete baclofen as well).', 'achievements': [{'comment': 'Acamprosate was discontinued mid-study due to undetectable serum levels and replaced with baclofen. Participants who already completed acamprosate were given the option to re-enroll and receive baclofen. Five participants received all 5 interventions; 26 received 4+ interventions.', 'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Participant declined to re-enroll for baclofen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Participant was not offered acamprosate; acamprosate was discontinued and replaced with baclofen', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'Participants engaged in a baseline visit to gather preliminary data and ensure study compliance. Participants were then randomly assigned to different sequences for receiving acamprosate, lovastatin, minocycline, baclofen, and placebo. There was a 2-week washout period between visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants received, in random order, a single dose of placebo, acamprosate, lovastatin, minocycline, or baclofen, with a two-week washout period between doses. Midway through the study (n=16) it was determined that acamprosate was undetectable in serum and this intervention was replaced by baclofen. Remaining participants (n=13) received baclofen and 5 participants were re-enrolled to receive baclofen or a second round of placebo, so investigators and participants would remain blinded to drug status during the baclofen visit. The second round of placebo was not analyzed.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24.71', 'spread': '8.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Woodcock Johnson Test of Cognitive Abilities - Auditory Attention Task', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.89', 'spread': '4.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measure Description: Woodcock Johnson Test of Cognitive Abilities III Auditory Attention subscale. Participants must identify orally presented words amid increasingly intense background noise. The scores for this subtask range from 0-50, with higher scores indicating a better outcome. Raw scores for this subscale are reported (rather than standard scores, or age- or grade-equivalents).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One participant did not complete the Woodcock Johnson.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-27', 'size': 181447, 'label': 'Study Protocol and Statistical Analysis Plan: Latest study protocol with baclofen', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-26T14:07', 'hasProtocol': True}, {'date': '2015-12-01', 'size': 550754, 'label': 'Study Protocol and Statistical Analysis Plan: Previous study protocol with original arms', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-01-26T14:32', 'hasProtocol': True}, {'date': '2019-08-30', 'size': 183307, 'label': 'Informed Consent Form: Latest consent form with baclofen', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-01-26T14:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study was designed as a 4-intervention crossover, with all study participants receiving all possible interventions. These were originally placebo, acamprosate, minocycline, and lovastatin. Midway through the study (n=16) it was determined that acamprosate was undetectable in serum and this intervention was replaced by baclofen. Remaining participants (n=13) received baclofen and 5 participants were re-enrolled to receive baclofen or a second round of placebo, so investigators and participants would remain blinded to drug status during the baclofen visit. The second round of placebo was not analyzed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2016-12-01', 'resultsFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2016-12-15', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-27', 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in EEG Relative Gamma Power', 'timeFrame': 'Pre-dose, 4-hour post-dose', 'description': 'EEG relative gamma power at rest was calculated as the percent of power in the gamma frequencies relative to the sum of power in all frequency bands, averaged across electrodes, and calculated separately at pre-dose and post-dose timepoints. To assess the impact of drug, the pre-dose relative gamma power was subtracted from post-dose relative gamma power. Higher numbers indicate more relative gamma power post-dose; lower numbers indicate more relative gamma power pre-dose.'}, {'measure': 'Clinical Global Impressions-Improvement', 'timeFrame': '4-hour post-dose', 'description': "The Clinical Global Impressions - Improvement (CGI-I) requires the clinician to assess how much the patient's illness has changed relative to pre-dose, from 1 (very much improved) to 7 (very much worse)."}], 'secondaryOutcomes': [{'measure': 'Woodcock Johnson Test of Cognitive Abilities - Auditory Attention Task', 'timeFrame': '4-hour post-dose', 'description': 'Woodcock Johnson Test of Cognitive Abilities III Auditory Attention subscale. Participants must identify orally presented words amid increasingly intense background noise. The scores for this subtask range from 0-50, with higher scores indicating a better outcome. Raw scores for this subscale are reported (rather than standard scores, or age- or grade-equivalents).'}, {'measure': 'Change From Pre-dose in the Repeatable Battery for the Assessment of Neuropsychological Status at 4 Hours Post Dose', 'timeFrame': 'Pre-dose, 4-hour post dose', 'description': 'Four 10-item lists of unrelated words were presented orally to the examinee who was then required to immediately recall words presented, at both pre-dose and post-dose timepoints. The impact of drug was assessed by subtracting the number of words remembered post-dose from the number of words remembered pre-dose. Lower numbers indicate more words remembered post-dose; higher numbers indicate more words remembered pre-dose.'}, {'measure': 'Test of Attentional Performance for Children (KiTAP) Test of Alertness', 'timeFrame': 'Predose, 4-hour post-dose', 'description': 'Computerized task where an examinee is required to push a key when a target stimulus is presented on the screen. Scores are presented as change in median reaction time (RT), in milliseconds.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fragile X Syndrome']}, 'referencesModule': {'references': [{'pmid': '36167501', 'type': 'DERIVED', 'citation': 'Jonak CR, Pedapati EV, Schmitt LM, Assad SA, Sandhu MS, DeStefano L, Ethridge L, Razak KA, Sweeney JA, Binder DK, Erickson CA. Baclofen-associated neurophysiologic target engagement across species in fragile X syndrome. J Neurodev Disord. 2022 Sep 27;14(1):52. doi: 10.1186/s11689-022-09455-9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to utilize neurophysiologic assessments, behavioral measures and clinical measures to assess how much deficits associated with Fragile X Syndrome from pre-dose to post-dose using pharmacology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects ages 15-55, with fragile X syndrome (FXS) who completed the study entitled "Mechanisms and brain circuits underlying fragile X syndrome (IRB # 2015-8425). FXS is defined as full FMR1 mutations (\\>200 CGG repeats) confirmed by genetic testing.\n* General good health as determined by physical exam, medical history and laboratory work up.\n\nExclusion Criteria:\n\n* Subjects with a history of intolerance to acamprosate, lovastatin, or minocycline will be excluded.\n* Subjects will also be excluded if they have taken any investigational drug within 3 months, have a history of substance abuse or dependence within 6 months, or significant psychiatric or central nervous system neurological disease unrelated to FXS.\n* Uncontrolled seizures impact EEG data as do anticonvulsants, barbiturates, lithium and benzodiazepines and are exclusions (within 5 half-lives). Those taking other psychiatric medications must be on stable doses for 4 weeks before any testing.\n* For female subjects of child bearing potential, a positive urine pregnancy test.\n* Potential subjects with a creatinine clearance \\< 50 mL/min will be excluded.\n* Identified medical issues, inability to tolerate study procedures or study drug per the discretion of the Principal Investigator.'}, 'identificationModule': {'nctId': 'NCT02998151', 'briefTitle': 'Neurophysiological and Acute Pharmacological Studies in FXS Patients', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Neurophysiological and Acute Pharmacological Studies in FXS Patients', 'orgStudyIdInfo': {'id': 'CIN001 - {LAM}'}, 'secondaryIdInfos': [{'id': 'U54HD082008', 'link': 'https://reporter.nih.gov/quickSearch/U54HD082008', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All Study Participants', 'description': 'Participants received, in random order, a single dose of placebo, acamprosate, lovastatin, minocycline, or baclofen, with a two-week washout period between doses. Midway through the study (n=16) it was determined that acamprosate was undetectable in serum and this intervention was replaced by baclofen. Remaining participants (n=13) received baclofen and 5 participants were re-enrolled to receive baclofen or a second round of placebo, so investigators and participants would remain blinded to drug status during the baclofen visit. The second round of placebo was not analyzed.', 'interventionNames': ['Drug: Acamprosate', 'Drug: Lovastatin', 'Drug: Minocycline', 'Drug: Placebo', 'Drug: Baclofen']}], 'interventions': [{'name': 'Acamprosate', 'type': 'DRUG', 'description': 'two 666mg pills', 'armGroupLabels': ['All Study Participants']}, {'name': 'Lovastatin', 'type': 'DRUG', 'description': 'two 20mg pills', 'armGroupLabels': ['All Study Participants']}, {'name': 'Minocycline', 'type': 'DRUG', 'description': 'two 135mg pills', 'armGroupLabels': ['All Study Participants']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo pill', 'armGroupLabels': ['All Study Participants']}, {'name': 'Baclofen', 'type': 'DRUG', 'description': 'one 30mg pill', 'armGroupLabels': ['All Study Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Craig A Erickson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}