Trial record 2 of 3 for:    minocycline and autism

Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome (LovaMiX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Université de Sherbrooke
Sponsor:
Collaborator:
FRAXA Research Foundation
Information provided by (Responsible Party):
Francois Corbin, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT02680379
First received: January 25, 2016
Last updated: June 21, 2016
Last verified: June 2016
  Purpose
The purpose of this study is to determine whether Lovastatin, Minocycline and the combination Lovastatin/Minocycline are effective in treating behavioral symptoms in Fragile X individuals.

Condition Intervention Phase
Fragile X Syndrome
Drug: Minocycline, then Minocycline/Lovastatin
Drug: Lovastatin, then Minocycline/Lovastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Exploring the Safety and Synergistic Effect of a Minocycline/Lovastatin Combined Treatment on the Behavior of Individuals With Fragile X Syndrome; Validation of New Biochemical and Neurophysiological Markers (LovaMix)

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks [ Time Frame: baseline, 8 weeks, 12 weeks, 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Scale improvement (CGI-I) [ Time Frame: baseline, 8 weeks, 12 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Change from baseline Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Before treatment and at the end of treatment (weeks 20) ] [ Designated as safety issue: No ]
  • Change from baseline Vineland II; adaptive behaviour scale at 20 weeks [ Time Frame: baseline, 20 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • (optional) Change in brain activity using Functional Magnetic Resonance Imaging (fMRI) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ] [ Designated as safety issue: No ]
    fMRI is a non-invasive method of assessing brain activity by detecting signal changes in blood flow and oxygenation known as BOLD (Blood-Oxygen-Level Dependent) contrast imaging.

  • (optional) Change in neurochemistry using Transcranial Magnetic Stimulation (TMS) at 8 and 20 weeks [ Time Frame: baseline, 8 weeks, 20 weeks ] [ Designated as safety issue: No ]
    Using an unpainful magnetic stimulation on the primary motor cortex, TMS will be used to assess intracortical facilitation and inhibition, corresponding respectively to glutamate and GABAergic processes.


Estimated Enrollment: 26
Study Start Date: March 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Minocycline, then Minocycline/Lovastatin
Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months.
Drug: Minocycline, then Minocycline/Lovastatin
Participants of this group will take 1 tablet of minocycline 50mg daily for 4 weeks, minocycline 100mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40mg for the following 12 weeks.
Other Name: Minocin
Experimental: Lovastatin, then Minocycline/Lovastatin
Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months
Drug: Lovastatin, then Minocycline/Lovastatin
Participants of this group will take 1 tablet of lovastatin 20 mg daily for 4 weeks, lovastatin 40 mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40 mg for the following 12 weeks.
Other Name: Mevacor

  Eligibility

Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a molecular diagnosis for fragile X syndrome
  • The participant must be accompanied by his sponsor who may be the person having parental authority, his tutor (for minor) or representative (for major inapt)
  • Identify a caregiver who spends at least six hours per day with the participant. The sponsor and the caregiver may be the same person
  • Intelligence quotient (IQ) < 70
  • ABC-C > 20
  • CGI-S ≥ 4

Exclusion Criteria:

  • Pregnant or breastfeeding subjects
  • Intolerance / allergy previous to statins, minocycline or tetracycline
  • Taking lovastatin or taking minocycline in the last 12 weeks
  • Personal history of myopathy, myalgia or high creatine kinase (CK) level
  • Renal disease / liver / hepatorenal balance disturbed, as antinuclear antibody (ANA) > 40
  • Concomitant use of prohibited drugs *
  • Taking two or more psychoactive medications except anticonvulsants
  • Untreated hypothyroidism and / or uncontrolled
  • Any other active medical condition
  • Amendment psychoactive treatment in the last 6 weeks prior to randomization * Prohibited drugs include other hypolipemic including gemfibrozil (or other fibrates) and niacin (nicotinic acid), angiotensin converting enzyme (ACE), cyclosporine, danazol, amiodarone, verapamil and inhibitors P450 (CYP3A4) (itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, inhibitors of HIV protease and nefazodone).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02680379

Contacts
Contact: Francois Corbin, MD/PhD info@cliniquexfragilequebec.org

Locations
Canada, Quebec
Centre de Recherche du CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Sylvie Auger, Research Coordinator    (1) 819-346-1110 ext 12737    info@cliniquexfragilequebec.org   
Principal Investigator: Francois Corbin, MD/PhD         
Sponsors and Collaborators
Université de Sherbrooke
FRAXA Research Foundation
Investigators
Principal Investigator: François Corbin, MD/PhD Fragile X Clinic, Centre de recherche du CHUS
  More Information

Additional Information:
Responsible Party: Francois Corbin, Dr Francois Corbin, MD, PHD, FRCPC, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT02680379     History of Changes
Other Study ID Numbers: 2016-1177 
Study First Received: January 25, 2016
Last Updated: June 21, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Université de Sherbrooke:
Fragile X Syndrome
Autism
FMR1
FRAXA

Additional relevant MeSH terms:
Minocycline
Syndrome
Fragile X Syndrome
Disease
Pathologic Processes
Mental Retardation, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Heredodegenerative Disorders, Nervous System
Lovastatin
L 647318
Dihydromevinolin
Anti-Bacterial Agents
Anti-Infective Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016