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NCT05630066: Aldebaran
A Study to Investigate the Pharmacokinetics (PK) and Safety and to Provide Proof of Mechanism of Alogabat in Children and Adolescents Aged 5-17 Years With Angelman Syndrome (AS) With Deletion Genotype.
Phase 2 trial testing Alogabat in Angelman Syndrome in 48 participants. Completed in 2 December 2025.
2 December 2025
Quick facts
| Lead sponsor | Hoffmann-La Roche |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 48 |
| Start date | 27 July 2023 |
| Primary completion | 2 December 2025 |
| Estimated completion | 2 December 2025 |
| Sites | 19 locations across France, Italy, Germany, Australia, United States, Spain |
Drugs / interventions tested
- Alogabat — full drug profile →
Conditions studied
- Angelman Syndrome — all drugs for Angelman Syndrome →
Sponsor
Hoffmann-La Roche — full company profile →
Who can join
Adults 5 to 17, any sex, with Angelman Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two-part, Phase IIa, multicenter, 12-week, open-label study. Up to 56 participants with deletion AS aged 5-17 years (inclusive) will be enrolled in the study.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Preclinical pharmacology of alogabat: a novel GABA<sub>A</sub>-α5 positive allosteric modulator targeting neurodevelopmental disorders with impaired GABA<sub>A</sub> signaling.
Cecere G, Ballard TM, Knoflach F, Honer M, et al · · 2025 · cited 3× · PMID 40761395 · DOI 10.3389/fphar.2025.1626078 -
Using the Bayley-4 and Vineland-3 in Angelman syndrome: barriers, solutions, and challenging items.
Halpin SN, Potter SN, Gwaltney A, Sadhwani A, et al · · 2025 · cited 1× · PMID 40462183 · DOI 10.1186/s13023-025-03817-x -
Crossing the finish line towards a disease-modifying treatment for Angelman syndrome.
Judson MC, de Almeida LP, Burdine RD, Chamberlain SJ, et al · · 2026 · PMID 41795090 · DOI 10.1186/s11689-026-09681-5
Verify or expand the search:
- PubMed search for NCT05630066
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Angelman Syndrome
Currently open trials in the same condition.
- NCT07181837 — A Phase 1/2 Study of the Safety and Efficacy of MVX-220 in Angelman Syndrome · Phase 1, PHASE2 · recruiting
- NCT06353620 — Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy · recruiting
- NCT06115109 — Angelman Natural History Study - FAST Spain · recruiting
- NCT05293184 — The Global Angelman Syndrome Registry · recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
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- NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
- NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
- NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
- NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · 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 NCT05630066 (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 Hoffmann-La Roche
- Last refreshed: 4 December 2025
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/NCT05630066.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing