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NCT04153175
Study to Assess Intracerebroventricular (ICV) Delivery of CT-010 in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
Phase 2 trial testing ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC) in Refractory Epilepsy in 30 participants. Terminated before completion.
1 March 2024
Quick facts
| Lead sponsor | Cerebral Therapeutics LLC |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 21 August 2020 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 11 locations across Israel, Australia |
Drugs / interventions tested
- ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)
- Placebo delivery via an implantable pump and a cranial port and dual lumen catheter (CIC)
Conditions studied
- Refractory Epilepsy — all drugs for Refractory Epilepsy →
Sponsor
Cerebral Therapeutics LLC — full company profile →
Who can join
Adults 18 to 70, any sex, with Refractory Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 2 double-blind, randomized, placebo-controlled study to assess the safety and efficacy of ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC) in subjects with focal seizures, with temporal lobe onset with or without secondary generalization. Up to 70 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to either CT-010 or placebo treatment. Up to 20 clinical centers will be enrolled.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Crossing the blood-brain barrier: emerging therapeutic strategies for neurological disease.
Pedder JH, Sonabend AM, Cearns MD, Michael BD, et al · · 2025 · cited 35× · PMID 39862873 · DOI 10.1016/s1474-4422(24)00476-9 -
Novel Developments to Enable Treatment of CNS Diseases with Targeted Drug Delivery.
Meyer AH, Feldsien TM, Mezler M, Untucht C, et al · · 2023 · cited 15× · PMID 37111587 · DOI 10.3390/pharmaceutics15041100 -
Comparison of <i>MALAT1</i> antisense oligonucleotide distribution following intracerebroventricular and lumbar intrathecal routes of administration.
Boyd MM, Mazur C, Pribnow K, Zanon RL, et al · · 2025 · PMID 41216427 · DOI 10.1016/j.omtn.2025.102742
Verify or expand the search:
- PubMed search for NCT04153175
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Refractory Epilepsy
Currently open trials in the same condition.
- NCT06425029 — Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application · NA · recruiting
- NCT06524479 — Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG · NA · recruiting
- NCT06241963 — High Definition Transcranial Direct Current Stimulation (HD-tDCS) for Refractory Epilepsy · NA · recruiting
- NCT06396494 — An Automated Navigation System for Deep Brain Electrode Implantation · active not recruiting
- NCT05493722 — Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy · EARLY_PHASE1 · recruiting
Other Cerebral Therapeutics LLC trials
Trials by the same sponsor.
- NCT04529954 — Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion · Phase 1, PHASE2 · terminated
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 NCT04153175 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Cerebral Therapeutics LLC
- Last refreshed: 13 March 2024
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/NCT04153175.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing