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Completed

NCT Number: NCT02680379

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

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.

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Key information

Conditions

Fragile X Syndrome Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Sex Chromosome Disorders X-Linked Intellectual Disability

Age range

8 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre de Recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Molecular diagnosis of fragile X syndrome
  • The participant must be accompanied his parent, legal tutor or legal representative.
  • Identify a caregiver who spends at least six hours per day with the participant (may be the parent, legal tutor, legal representative or an other person).
  • IQ < 70
  • ABC-C score > 20
  • CGI-Severity score ≥ 4

Exclusion criteria

  • Pregnant or breastfeeding participants
  • Previous intolerance/allergy to statins, minocycline or tetracyclines
  • Participants who have taken lovastatin or minocycline in the last 12 weeks
  • Personal history of myopathy, myalgia or high creatine kinase (CK) levels
  • Renal disease / liver disease / disturbed hepatorenal tests
  • Participants taking more than three psychoactive medications (except anticonvulsants)
  • Untreated or uncontrolled hypothyroidism
  • Any other active medical condition
  • Modification of psychoactive treatment in the last 6 weeks prior to randomization
  • Participants under the age of 13 years who have incomplete formation of the crown of their teeth (except possibly their 3rd molars) as shown by panorex
  • Concomitant use of prohibited drugs
  • 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).

Treatment and study plan

Minocycline, then Minocycline/Lovastatin

Drug

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 names: Minocin

Lovastatin, then Minocycline/Lovastatin

Drug

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 names: Mevacor

Primary outcomes

  1. 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

Secondary outcomes

  1. Clinical Global Impression Scale improvement (CGI-I)

    Time frame: baseline, 8 weeks, 12 weeks, 20 weeks

  2. Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks

    Time frame: baseline, 8 weeks, 20 weeks

  3. Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks

    Time frame: baseline, 8 weeks, 20 weeks

  4. Behavior Rating Inventory of Executive Function (BRIEF)

    Time frame: Before treatment and at the end of treatment (weeks 20)

  5. Change from baseline Vineland II; adaptive behaviour scale at 20 weeks

    Time frame: baseline, 20 weeks

Other outcomes

  1. (optional) Change in brain activity using Functional Magnetic Resonance Imaging (fMRI) at 8 and 20 weeks

    Time frame: baseline, 8 weeks, 20 weeks

    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.

  2. (optional) Change in neurochemistry using Transcranial Magnetic Stimulation (TMS) at 8 and 20 weeks

    Time frame: baseline, 8 weeks, 20 weeks

    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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • FRAXA Research Foundation

Registry information

Official study 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)

Acronym: LovaMiX

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 11, 2016
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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