Focal EpilepsyPhase 1/2NCT04529954
Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion
A Phase 1/2 study testing Valproic Acid delivered to ICV in people with Focal Epilepsy, run by Cerebral Therapeutics LLC at 8 sites in 2 countries.
Trial summary
This is a non-randomized open-label extension study for subjects having completed protocol DA071976 or CLN100P.01. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Focal Epilepsy
- What is being tested?
- Valproic Acid delivered to ICV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jan 2021to 1 Mar 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed the DA07976 or CLN100P.01 Study
- In the opinion of the investigator, if the subject were to be removed from study and associated therapy, subject would have worsening/increase in disabling seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
- Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium).
- Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver.
- Subject has hearing, vision, and physical abilities adequate to perform assessments, with or without corrective aids, including keeping a seizure and medication diary during study follow-up.
- Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements.
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- Needs be literate in English or native language of the country of the study enrollment to complete neuropsychological testing.
- Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual.
- Women of childbearing potential must be using a medically accepted method of contraception and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine or blood sample collected per SOE.
Who cannot join
- 1. Subject has any significant neurologic disease other than epilepsy. 2. Subject has had status epilepticus refractory to benzodiazepines and phenytoin in the past year 3. Subject is currently taking oral valproic acid or sodium divalproex. 4. Subject has known allergy to valproic acid, divalproex sodium, Epilim, or Depacon.
- 5. Subject has unstable depression or any major psychiatric disorder including psychosis, major depression, bipolar disorder that in the opinion of the Investigator would put the subject at risk as a participant in the study.
- 6. Subject has history or evidence of congestive heart failure, clinically significant peripheral edema, or anemia with a hematocrit <30%.
- 7. Subject has current diagnosis of cancer requiring treatment. 8. Subject in the opinion of the Investigator, is not a suitable candidate for cranial surgery for any reason.
- 9. Subject has known HIV infection or known or suspected prion disease. 10. Subject has known allergies to drugs or excipients. 11. Subject is breastfeeding, pregnant, or expressed intent on becoming pregnant during the course of the study and Investigator feels pregnancy is a likely outcome during the study 12. In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive CNS disease that in the opinion of the Investigator would put the subject at risk as a participant in the study.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia5 sites
Mater Brisbane
Brisbane, New South Wales
RBWH
Brisbane, New South Wales
SVHM
Melbourne, Victoria
The Alfred
Melbourne, Victoria
The Austin
Melbourne, Victoria
Israel3 sites
Hadassah Medical Center
Jerusalem
Sheeba Medical Center
Jerusalem
Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: An Open-Label Extension Study to Investigate the Long-Term Safety, and Tolerability of Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
This is a non-randomized open-label extension study for subjects having completed protocol DA071976 or CLN100P.01.
- Conditions
- Focal Epilepsy
- Being tested
- Valproic Acid delivered to ICV
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic Acid delivered to ICVDrug
Valproic Acid delivered to ICV via an implantable pump and catheter system
| Study group | Role | What they receive |
|---|---|---|
| Open-Label Safety | Experimental | Participants roll-over from DA071976 or CLN100P.02 Receives: Drug: Valproic Acid delivered to ICV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured as drug or device related SAEs
The primary objective is to assess long-term safety and tolerability of ICV delivery of Valproate as measured by drug and device related adverse events.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerebral Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529954
- Sponsor's protocol ID
- CLN100P.02
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2020
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Investigate the Long-Term Safety, and Tolerability of Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
- ClinicalTrials.gov ID
- NCT04529954
- Acronym / sponsor ID
- CLN100P.02
- Conditions
- Focal Epilepsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cerebral Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized open-label extension study for subjects having completed protocol DA071976 or CLN100P.01.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-Label Safety | Experimental | Drug: Valproic Acid delivered to ICVParticipants roll-over from DA071976 or CLN100P.02 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Completed the DA07976 or CLN100P.01 Study
- In the opinion of the investigator, if the subject were to be removed from study and associated therapy, subject would have worsening/increase in disabling seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
- Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium).
- Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver.
- Subject has hearing, vision, and physical abilities adequate to perform assessments, with or without corrective aids, including keeping a seizure and medication diary during study follow-up.
Key exclusion criteria (5 listed)
- 1. Subject has any significant neurologic disease other than epilepsy. 2. Subject has had status epilepticus refractory to benzodiazepines and phenytoin in the past year 3. Subject is currently taking oral valproic acid or sodium divalproex. 4. Subject has known allergy to valproic acid, divalproex sodium, Epilim, or Depacon.
- 5. Subject has unstable depression or any major psychiatric disorder including psychosis, major depression, bipolar disorder that in the opinion of the Investigator would put the subject at risk as a participant in the study.
- 6. Subject has history or evidence of congestive heart failure, clinically significant peripheral edema, or anemia with a hematocrit <30%.
- 7. Subject has current diagnosis of cancer requiring treatment. 8. Subject in the opinion of the Investigator, is not a suitable candidate for cranial surgery for any reason.
- 9. Subject has known HIV infection or known or suspected prion disease. 10. Subject has known allergies to drugs or excipients. 11. Subject is breastfeeding, pregnant, or expressed intent on becoming pregnant during the course of the study and Investigator feels pregnancy is a likely outcome during the study 12. In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive CNS disease that in the opinion of the Investigator would put the subject at risk as a participant in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic Acid delivered to ICVValproic Acid delivered to ICV via an implantable pump and catheter system | Drug | Open-Label Safety |
Primary outcome
Safety measured as drug or device related SAEs
Time frame: 2-years
The primary objective is to assess long-term safety and tolerability of ICV delivery of Valproate as measured by drug and device related adverse events.
Results and safety
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Valproic Acid delivered to ICV in people with Focal Epilepsy, run by Cerebral Therapeutics LLC at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured as drug or device related SAEs (time frame: 2-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.