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Study to Assess Intracerebroventricular (ICV) Delivery of CT-010 in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization

NCT04153175 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-13

No results posted yet for this study

Summary

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.

Conditions

  • Refractory Epilepsy

Interventions

COMBINATION_PRODUCT

ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)

Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of CT-010.

COMBINATION_PRODUCT

Placebo delivery via an implantable pump and a cranial port and dual lumen catheter (CIC)

Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of a placebo (saline).

Sponsors & Collaborators

  • Cerebral Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-21
Primary Completion
2024-03-01
Completion
2024-03-01
FDA Drug
Yes

Countries

  • Australia
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153175 on ClinicalTrials.gov