NCT05558371 (ICCRN) is a clinical trial of No intervention. in CDKL5, sponsored by University of Colorado, Denver.

Who is sponsoring NCT05558371?

NCT05558371 is sponsored by University of Colorado, Denver.

What drugs are being tested in NCT05558371?

Interventions in NCT05558371: No intervention..

What condition does NCT05558371 study?

NCT05558371 studies CDKL5, CDKL5 Deficiency Disorder, CDD.

Is NCT05558371 still recruiting?

NCT05558371 is currently recruiting now. Last updated 6 December 2023.

Last reviewed 2023-12-06 · How we verify

NCT05558371: ICCRN

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

International CDKL5 Clinical Research Network

Recruiting now Last updated 6 December 2023

What this trial tests

trial testing No intervention. in CDKL5 in 1,000 participants. Currently enrolling.

Timeline

15 February 2021

Primary endpoint
15 February 2026

15 February 2027

Quick facts

Lead sponsor	University of Colorado, Denver
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	15 February 2021
Primary completion	15 February 2026
Estimated completion	15 February 2027
Sites	9 locations across United States, Australia

Drugs / interventions tested

No intervention.

Conditions studied

CDKL5 — all drugs for CDKL5 →
CDKL5 Deficiency Disorder — all drugs for CDKL5 Deficiency Disorder →
CDD — all drugs for CDD →

Sponsor

University of Colorado, Denver

Who can join

Adults 1 Month to 100, any sex, with CDKL5 or CDKL5 Deficiency Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pathogenic variants in the Cyclin-dependent kinase like 5 (CDKL5) gene cause CDKL5 deficiency disorder (CDD, MIM 300672, 105830), a severe developmental and epileptic encephalopathy associated with cognitive and motor impairments and cortical visual impairment. While capability for disease modifying therapies is accelerating, there is a critical barrier for clinical trial readiness that may result in failure of these therapies, not due to lack of efficacy but due to lack of validated outcome measures and biomarkers. The measures and biomarkers validated here will be adaptable to other developmental and epileptic encephalopathies.

Publications & conference data

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

CDKL5 Deficiency Disorder: Some Lessons Learned 20 Years After the First Description.
Pestana Knight EM, Olson HE. · · 2024 · cited 2× · PMID 38411242 · DOI 10.1352/1944-7558-129.2.101
The long odyssey for the DEE-CDKL5 diagnosis: A call for action.
Valente KD, Melo F, Marin R, Vega G, et al · · 2024 · cited 1× · PMID 39248178 · DOI 10.1002/epi4.13031
Beyond Seizures as an Outcome Measure: A Global Severity Scoring System for CDKL5 Deficiency Disorder.
Jacoby P, Marsh ED, Demarest S, Saldaris JM, et al · · 2025 · PMID 41235743 · DOI 10.1002/brb3.71061

Verify or expand the search:

Other trials of No intervention.

Trials testing the same drug.

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Other recruiting trials for CDKL5

Currently open trials in the same condition.

NCT06448663 — Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD) · NA · recruiting

Other University of Colorado, Denver trials

Trials by the same sponsor.

NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
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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 NCT05558371 (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 University of Colorado, Denver
Last refreshed: 6 December 2023

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/NCT05558371.

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