Fragile X SyndromePhase 2LovaMiXNCT02680379
Combined Treatment of Minocycline and Lovastatin to Treat Individuals With Fragile X Syndrome
A Phase 2 study testing Minocycline, then Minocycline/Lovastatin and Lovastatin, then Minocycline/Lovastatin in people with Fragile X Syndrome, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 45 years
- Conditions the study is for
- Fragile X Syndrome
- What is being tested?
- Minocycline, then Minocycline/Lovastatin and Lovastatin, then Minocycline/Lovastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Nov 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Fragile X Syndrome
- Being tested
- Minocycline, then Minocycline/Lovastatin, Lovastatin, then Minocycline/Lovastatin
- Keywords
- Fragile X Syndrome, Autism, FMR1, FRAXA
- Medical subject headings
- Fragile X Syndrome, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline, then Minocycline/LovastatinDrug
Also called Minocin
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.
Lovastatin, then Minocycline/LovastatinDrug
Also called Mevacor
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.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline, then Minocycline/Lovastatin | Experimental | Participants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months. Receives: Drug: Minocycline, then Minocycline/Lovastatin |
| Lovastatin, then Minocycline/Lovastatin | Experimental | Participants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months Receives: Drug: Lovastatin, then Minocycline/Lovastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Aberrant Behavior Checklist-Community (ABC-C) total score at 8,12 and 20 weeks
Measured: baseline, 8 weeks, 12 weeks, 20 weeks
Secondary outcomes (5)
Clinical Global Impression Scale improvement (CGI-I)
Measured: baseline, 8 weeks, 12 weeks, 20 weeks
Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks
Measured: baseline, 8 weeks, 20 weeks
Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks
Measured: baseline, 8 weeks, 20 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Measured: Before treatment and at the end of treatment (weeks 20)
Change from baseline Vineland II; adaptive behaviour scale at 20 weeks
Measured: baseline, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fragile X SyndromeStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- FRAXA Research Foundation
- Responsible party
- Principal investigator, Francois Corbin, Université de Sherbrooke
- Investigators
- François Corbin, MD/PhD, Principal investigator, Fragile X Clinic, Centre de recherche du CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680379
- Sponsor's protocol ID
- 2016-1177
- Acronym
- LovaMiX
- Status last verified
- Oct 2018
- First submitted
- 25 Jan 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Morin-Parent F, Champigny C, Cote S, Mohamad T, Hasani SA, Caku A, Corbin F, Lepage JF. Neurophysiological effects of a combined treatment of lovastatin and minocycline in patients with fragile X syndrome: Ancillary results of the LOVAMIX randomized clinical trial. Autism Res. 2024 Sep;17(9):1944-1956. doi: 10.1002/aur.3222. Epub 2024 Sep 9.
PubMed 39248107
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02680379
- Acronym / sponsor ID
- LovaMiX / 2016-1177
- Conditions
- Fragile X Syndrome
- Keywords
- Fragile X Syndrome, Autism, FMR1, FRAXA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- FRAXA Research Foundation
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 11 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline, then Minocycline/Lovastatin | Experimental | Drug: Minocycline, then Minocycline/LovastatinParticipants will take minocycline then a combined treatment of minocycline/lovastatin for 3 months. |
| Lovastatin, then Minocycline/Lovastatin | Experimental | Drug: Lovastatin, then Minocycline/LovastatinParticipants will lovastatin then a combined treatment of minocycline/lovastatin for 3 months |
Who may qualify
- Ages
- 8 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline, then Minocycline/LovastatinAlso: MinocinParticipants 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. | Drug | Minocycline, then Minocycline/Lovastatin |
| Lovastatin, then Minocycline/LovastatinAlso: MevacorParticipants 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. | Drug | Lovastatin, then Minocycline/Lovastatin |
Primary outcome
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
5 secondary outcomes
Clinical Global Impression Scale improvement (CGI-I)
Time frame: baseline, 8 weeks, 12 weeks, 20 weeks
Change from baseline Social Responsiveness Scale (SRS) at 8 and 20 weeks
Time frame: baseline, 8 weeks, 20 weeks
Anxiety, depression and mood scale (ADAMS), change from baseline to 8 and 20 weeks
Time frame: baseline, 8 weeks, 20 weeks
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Before treatment and at the end of treatment (weeks 20)
Change from baseline Vineland II; adaptive behaviour scale at 20 weeks
Time frame: baseline, 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 39248107Morin-Parent F, Champigny C, Cote S, Mohamad T, Hasani SA, Caku A, Corbin F, Lepage JF. Neurophysiological effects of a combined treatment of lovastatin and minocycline in patients with fragile X syndrome: Ancillary results of the LOVAMIX randomized clinical trial. Autism Res. 2024 Sep;17(9):1944-1956. doi: 10.1002/aur.3222. Epub 2024 Sep 9.
- Investigator profileLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Corbin, MD/PhD principal investigator
Fragile X Clinic, Centre de recherche du CHUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline, then Minocycline/Lovastatin and Lovastatin, then Minocycline/Lovastatin in people with Fragile X Syndrome, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.