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NCT04823052: IMPACT-FXS
Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40
Phase 2 trial testing Sulindac (HLX-0201), dose strength 1 in Fragile X Syndrome. Withdrawn.
19 October 2022
Quick facts
| Lead sponsor | Healx Limited |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Start date | 25 May 2022 |
| Primary completion | 19 October 2022 |
| Estimated completion | 19 October 2022 |
| Sites | 10 locations across United States, Australia |
Drugs / interventions tested
- Sulindac (HLX-0201), dose strength 1 — full drug profile →
- Sulindac (HLX-0201), dose strength 2 — full drug profile →
- Placebo
- Gaboxadol (HLX-0206) — full drug profile →
Conditions studied
- Fragile X Syndrome — all drugs for Fragile X Syndrome →
Sponsor
Healx Limited — full company profile →
Who can join
Adults 13 to 40, male only, with Fragile X Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to investigate the safety, tolerability and efficacy of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in males with Fragile X Syndrome (FXS) with confirmed full FMR1 mutation treated over a 10 week period in an outpatient setting.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
The future of pharmaceuticals: Artificial intelligence in drug discovery and development.
Fu C, Chen Q. · · 2025 · cited 18× · PMID 40893437 · DOI 10.1016/j.jpha.2025.101248 -
Neurodevelopment and early pharmacological interventions in Fragile X Syndrome.
Milla LA, Corral L, Rivera J, Zuñiga N, et al · · 2023 · cited 9× · PMID 37599992 · DOI 10.3389/fnins.2023.1213410 -
A New Era of Artificial Intelligence (AI): Transforming Drug Discovery and Development.
Ali S, Tian X, Chen H, Zhou J. · · 2025 · cited 7× · PMID 41306069 · DOI 10.1021/acs.jmedchem.5c03159
Verify or expand the search:
- PubMed search for NCT04823052
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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)
- Trial protocol + status: ClinicalTrials.gov NCT04823052 (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 Healx Limited
- Last refreshed: 8 December 2022
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/NCT04823052.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing