NCT00858689 is a NA clinical trial of Minocycline in Fragile X Syndrome, sponsored by FRAXA Research Foundation.

Who is sponsoring NCT00858689?

NCT00858689 is sponsored by FRAXA Research Foundation.

What drugs are being tested in NCT00858689?

Interventions in NCT00858689: Minocycline.

What condition does NCT00858689 study?

NCT00858689 studies Fragile X Syndrome.

Is NCT00858689 still recruiting?

NCT00858689 is currently completed. Last updated 16 February 2016.

Are results published for NCT00858689?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2016-02-16 · How we verify

NCT00858689

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Add-on Pilot Trial of Minocycline in Fragile X Syndrome

Completed NA Results posted Last updated 16 February 2016

What this trial tests

NA trial testing Minocycline in Fragile X Syndrome in 20 participants. Completed in 1 January 2009.

Timeline

1 October 2007

Primary endpoint
1 November 2008

1 January 2009

Quick facts

Lead sponsor	FRAXA Research Foundation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 October 2007
Primary completion	1 November 2008
Estimated completion	1 January 2009
Sites	1 location across Canada

Drugs / interventions tested

Minocycline (MINOCYCLINE) — full drug profile →

Conditions studied

Fragile X Syndrome — all drugs for Fragile X Syndrome →

Sponsor

FRAXA Research Foundation

Who can join

Adults 13 to 35, any sex, with Fragile X Syndrome. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline of ABC Irritability Subtest Score at 8 Weeks
Time frame: Baseline and 8 weeks
The 15-item Irritability Scale includes questions about aggression, self-injury, tantrums, agitation, and unstable mood on a scale of 0 to 45 with higher scores indicating greater severity. This scale has been successfully used in previous medication studies in children with autism and in patients with FXS and in a controlled trial of ampakine CX516 in FXS. All ABC subscales showed good reliabilit
ABC Irritability Subtest Score
Time frame: 8 weeks
ABC Irritability subtest score was used
ABC Irritability Subtest Score
Time frame: 1 year
ABC (Aberrant behavior checklist) Irritability subtest score was used

Sponsor's own description

Fragile X Syndrome (FXS) is the most common known inherited form of mental impairment, developmental disability and autism. Minocycline is an antibiotic that has recently been used to treat the mouse model for Fragile X, and was found to reverse the structural abnormalities that are seen their brain cells. The purpose of this research study is to determine if minocycline is an effective treatment for patients with fragile X syndrome (FXS).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Open-label add-on treatment trial of minocycline in fragile X syndrome.
Paribello C, Tao L, Folino A, Berry-Kravis E, et al · · 2010 · cited 159× · PMID 20937127 · DOI 10.1186/1471-2377-10-91
Parent-reported outcome measures evaluating communication in individuals with rare neurodevelopmental disorders: A systematic review.
Saldaris JM, Ayalde J, Kankanange S, Keeley J, et al · · 2024 · cited 2× · PMID 39141588 · DOI 10.1111/1460-6984.13100

Verify or expand the search:

Other trials of Minocycline

Trials testing the same drug.

NCT05605366 — Minocycline In Neurocognitive Outcomes - Sickle Cell Disease · Phase 1 · not yet recruiting
NCT07305896 — Efficacy and Safety of Minocycline in the Treatment of Intracerebral Hemorrhage · NA · not yet recruiting
NCT07068607 — Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradicatio · Phase 4 · recruiting
NCT06523764 — Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment · Phase 4 · active not recruiting
NCT06120140 — Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small · Phase 2 · recruiting

Other recruiting trials for Fragile X Syndrome

Currently open trials in the same condition.

NCT06279858 — Probiotic Intervention for Microbiome Modifications and Clinical Improvements in Fragile X Syndrome · NA · recruiting
NCT06088589 — Speech-in-noise Perception in Autism and Fragile X · NA · recruiting
NCT06227780 — Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders · NA · recruiting
NCT05367960 — An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome · Phase 3 · active not recruiting
NCT06560242 — Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00858689 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by FRAXA Research Foundation
Last refreshed: 16 February 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00858689.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing