Epilepsy, Complex PartialPhase 20602NCT01002820
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
A Phase 2 study testing ganaxolone in people with Epilepsy, Complex Partial, run by Marinus Pharmaceuticals at 7 sites in United States.
Trial summary
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Epilepsy, Complex Partial
- What is being tested?
- ganaxolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2009to Aug 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as:
- having had no major adverse events thought to be drug related
- deriving benefit from ganaxolone treatment
- be properly informed of the nature and risks of the study and give written informed consent prior to study entry
- must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test
Who cannot join
- significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
- unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
- history of chronic non-compliance with drug regimens
- females currently breastfeeding
- AST or ALT levels greater than 3 times the upper limit of normal at screen
- Inability to withhold grapefruit or grapefruit products during the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Albany Medical Center, Dept of Neurology
Albany, New York, 12208
Ohio State University
Columbus, Ohio, 43210
University of Kentucky, Dept of Neurology
Lexington, Kentucky, 40536
University of Southern California, Dept of Neurology
Los Angeles, California, 90033
Riddle Health Care Center II
Philadelphia, Pennsylvania, 19063
Thomas Jefferson University, Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, 19107
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
- Conditions
- Epilepsy, Complex Partial
- Being tested
- ganaxolone
- Keywords
- Epileptic Seizures, Seizure Disorder, Seizures, Convulsions, Anticonvulsant, Anticonvulsive, Antiepileptic, Ganaxolone
- Medical subject headings
- Epilepsy, Complex Partial, Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ganaxoloneDrug
Also called CCD 1042, CAS 383-98323-2, 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-one
liquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year
| Study group | Role | What they receive |
|---|---|---|
| participants | Experimental | all subjects participating in 0602 are receiving ganaxolone for seizure control Receives: Drug: ganaxolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators Global Assessment
Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline.
Measured: Screening through 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epilepsy, Complex PartialStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marinus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002820
- Sponsor's protocol ID
- 1042-0602
- Acronym
- 0602
- Status last verified
- May 2022
- First submitted
- 16 Oct 2009
- Last updated
- 7 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment Protocol for Ganaxolone as add-on Therapy in Adult Patients With Uncontrolled Partial-onset Seizures Deriving Benefit From Protocol 1042-0601
- ClinicalTrials.gov ID
- NCT01002820
- Acronym / sponsor ID
- 0602 / 1042-0602
- Conditions
- Epilepsy, Complex Partial
- Keywords
- Epileptic Seizures, Seizure Disorder, Seizures, Convulsions, Anticonvulsant, Anticonvulsive, Antiepileptic, Ganaxolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Marinus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Posted 7 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participants | Experimental | Drug: ganaxoloneall subjects participating in 0602 are receiving ganaxolone for seizure control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- subjects who have completed all study visits from previous protocol 1042-0601 and have been deemed eligible by the Investigator as:
- having had no major adverse events thought to be drug related
- deriving benefit from ganaxolone treatment
- be properly informed of the nature and risks of the study and give written informed consent prior to study entry
- must be willing to use a medically acceptable method of birth control and if female of child-bearing potential, have a negative qualitative serum pregnancy test
Key exclusion criteria (6 listed)
- significant medical or surgical condition at screening or that develops during protocol participation that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems, or other conditions that would place the subject under increased risk
- unwilling to use a double-barrier method of birth control or submit to a serum pregnancy test
- history of chronic non-compliance with drug regimens
- females currently breastfeeding
- AST or ALT levels greater than 3 times the upper limit of normal at screen
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 |
|---|---|---|
| ganaxoloneAlso: CCD 1042, CAS 383-98323-2, 3 alpha-hydroxy, 3 beta-methyl, 5 alpha-pregnan-20-oneliquid suspension, 50 mg/mL, up to 500 mg/day TID or 1500 mg/day, up to 1 year | Drug | participants |
Primary outcome
Investigators Global Assessment
Time frame: Screening through 52 weeks
Investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. The investigator's global assessment of the patient's response to ganaxolone treatment was collected during the study to support continued trial participation. Responses categories were Improved Markedly, Improved Moderately, Improved Slightly and No change from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ganaxolone in people with Epilepsy, Complex Partial, run by Marinus Pharmaceuticals at 7 sites in United States.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Investigators Global Assessment (time frame: Screening through 52 weeks). 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 7 Sep 2022.