Partial EpilepsyPhase 2NCT00465517
A Randomized, Controlled Trial of Ganaxolone in Adult Uncontrolled Partial-Onset Seizures
A Phase 2 study testing Ganaxolone in people with Partial Epilepsy and Catamenial Epilepsy, run by Marinus Pharmaceuticals at 27 sites in United States.
Trial summary
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Partial Epilepsy, Catamenial Epilepsy
- What is being tested?
- Ganaxolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 27 sitesUnited States
- Study dates
- Feb 2007to Nov 2008
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of epilepsy with POS with or without secondary generalized seizures according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and CT or MRI of the brain to rule out progressive structural lesions and EEG with results consistent with partial-onset epilepsy.
- During the 8 week baseline period preceding randomization visit (Visit 4), participants should have a documented seizure frequency of ≥ 3CPS per 4 weeks on average.
- Participants should not be seizure free for more than 28 consecutive days during treatment with a stable dose of AEDs [Note: Participants with historically sufficiently high seizure frequency who fall short 1 seizure in any 4 weeks period or with a seizure-free period > 28 consecutive days may be allowed to enter the study after discussion with the Medical Monitor. Prolongation of the screening period for questionable cases may also be allowed by the Medical Monitor.]
- Treatment with a stable dose of up to 3 (FDA approved) current AEDs for 1 month prior to screening.
- Maintenance of current AEDs without a change in dosing for the duration of study.
- Concomitant vigabatrin not permitted;
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- Felbamate is allowed if the participant has been on felbamate for at least 18 months and has stable laboratory tests) for the course of the study. [Note: A shorter period for stable laboratory results may be allowed by the Medical Monitor, depending on the extent of dose change and the half-life of the AED.]
- Participants receiving treatment with a vagal nerve stimulator (VNS) may be included as long as the VNS has been in place for at least 12 months prior to entry into the study, the VNS battery is not due for replacement during 0600 subject participation, and stimulation parameters have been kept constant for 1 month prior to screening. VNS will be counted as 1 of the 3 concomitant AEDs.
- Male or female, 18 to 69 years of age (inclusive). [Note: Participants who are > 69 years of age but are of good health condition may be allowed to enter the study after discussion with and approval by the Medical Monitor.]
- A 12-lead electrocardiogram (ECG) w/o clinically significant abnormalities.
- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.
- Able to participate for the full term of study.
- Able to keep a seizure \& medication diary throughout the course of the study.
- Sexually active women of childbearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine sample collected at the initial screening visit. A woman of childbearing potential is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or adequate barrier methods (e.g., diaphragm and foam). An oral contraceptive alone is not considered adequate for the purpose of this study. Use of oral contraceptives in combination with another method (eg, a spermicidal cream) is acceptable.in participants who are not sexually active, abstinence is an acceptable form of birth control and serum β-HCG must be tested per protocol.
- Participants with a history of depression who are stable and may be taking 1 anti-depressant medication.
Who cannot join
- Presence of non-motor simple partial seizures only.
- History of pseudoseizures in the last 5 years.
- History of a primary generalized seizure in the last 5 years.
- Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed).
- Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease.
- Status epilepticus within the last year prior to randomization.
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- Clinically unstable psychiatric disorder within the last 2 years.
- Suicidal attempt within the last 5 years or current significant suicidal ideation.
- History of psychosis within the last 5 years. [Note: Participants who suffered a psychosis that can well be explained by exogenous factors may be allowed to enter the study after discussion with and approval by the Medical Monitor.]
- Current use of neuroleptics for psychosis.
- A significant medical or surgical condition at screening which might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or hepatic systems or other conditions that would place the subject at increased risk.
- Known sensitivity or allergy to progesterone or related steroid compounds.
- History of drug use or alcohol abuse within the past 5 years.
- Sexually active WCBP who are unwilling to use a double-barrier method and establish that they are currently not pregnant by submitting to a pregnancy test.
- Females who are currently breastfeeding.
- history of chronic noncompliance with drug regimens.
- Exposure to any other investigational drug or device within 30 days prior to screening.
- Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3 times upper limits of normal (ULN) at screening.
- Benzodiazepines may be used intermittently for the control of seizure clustering as a one time rescue up to a maximum of 4 occasions as follows:
- Participants who need benzodiazepines for control of seizures more than once per month or more than 4 times total during the Titration and Maintenance Phases will be discontinued.
- Once during the Titration Phase
- No more than once per month during the Maintenance Phase
- Each occasion may be a period of 24 hours, during which up to 3 doses of benzodiazepine may be used.
- If a participant is taking a benzodiazepine chronically for epilepsy and non-epilepsy conditions, it will be counted as 1 of the 3 AEDs and the dose cannot be changed during the study.
- Participant has history of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
- Inability to withhold grapefruit and grapefruit juice from diet for the entire clinical trial.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Neurosciences Institute at Albany Medical Center
Albany, New York, 12208
Emory HealthCare
Atlanta, Georgia, 30322
Anchutz Outpatient Pavillion Neurosciences Clinic/ University of Colorado Hospital
Aurora, Colorado, 80010-0045
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
University of Alabama
Birmingham, Alabama, 35294-0021
Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, 63017
Ohio State University Medical Center
Columbus, Ohio, 43210
Neurological Clinic of Texas, P.A.
Dallas, Texas, 75230
2799 West Grand blvd. CFP 071
Detroit, Michigan, 48202
University of Florida McKnight Brain Institute
Gainesville, Florida, 32610-0236
Overlook Hospital and Hackensack Medical Center
Hackensack, New Jersey, 07601
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Kentucky, Dept. of Neurology
Lexington, Kentucky, 40536
Arkansas Epilepsy Program
Little Rock, Arkansas, 72205
University of Southern California Adult Comprehensive Epilepsy Center
Los Angeles, California, 90033
Riddle Health Care Center for Neuroscience
Media, Pennsylvania, 19063
Vanderbilt University Medical Ctr
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
Drexel University / Hahneman Hospital
Philadelphia, Pennsylvania, 19102
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Virginia Commonwealth University
Richmond, Virginia, 23298
University of California-Davis
Sacramento, California, 95817
Minnesota Epilepsy Group, PA
Saint Paul, Minnesota, 55102-2383
Intercoastal Medicine
Sarasota, Florida, 34232
Southern Illinois University Medical Center
Springfield, Illinois, 62702
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Subjects With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.
Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
- Conditions
- Partial Epilepsy, Catamenial Epilepsy
- Being tested
- Ganaxolone, Placebo
- Keywords
- Partial onset seizures, Complex-partial seizures, Anticonvulsant, Partial seizures, Catamenial epilepsy
- Medical subject headings
- Epilepsies, Partial, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanaxoloneDrug
Oral suspension 200-500 mg 3x/day
PlaceboOther
non-active placebo
| Study group | Role | What they receive |
|---|---|---|
| ganaxolone | Experimental | active study drug Receives: Drug: Ganaxolone |
| non-active drug | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)] during Weeks 1 through 10.
Measured: Week 1 through Week 10
Secondary outcomes (15)
Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including POS with or without secondary generalization, but not non-motor SPS] during the Weeks 3 through 10
Measured: Week 3 through Week 10
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline and at Week 1 through Week 10
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Summary of change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline and at Week 3 through Week 10
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline and at Week 1 through Week 10
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Summary of percent change from Baseline in mean weekly seizure frequency is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline and at Week 3 through Week 10
Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10
Mean weekly Seizure Frequency for each week post-dosing During Weeks 1 to 10 is presented.
Measured: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10
Seizure subtypes included Complex partial seizures (CPS), Generalized tonic-clonic seizure (GTCS), and Simple partial seizure (SPS)-motor. Percent Change from Baseline in Mean Weekly Seizure frequency by seizure subtype is presented. Baseline was defined as the Day 0 assessment before study drug infusion. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Measured: Baseline and at Week 1 through Week 10
Number of Responders During Weeks 1 Through 10
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Measured: Baseline and at Week 1 through Week 10
Number of Responders During Weeks 3 Through 10
Responders were defined as participants experiencing ≥50% of reduction in mean weekly seizure frequency from the Baseline. Baseline was defined as the Day 0 assessment before study drug infusion.
Measured: Baseline and at Week 3 through Week 10
Number of Seizure-free Participants Up to Week 2
Number of seizure-free participants is presented.
Measured: Up to Week 2
Number of Seizure-free Participants During Weeks 3 Through 10
Number of seizure-free participants is presented.
Measured: Week 3 through Week 10
Number of Seizure-free Participants During Weeks 1 Through 10
Number of seizure-free participants is presented.
Measured: Week 1 through Week 10
Number of Seizure-free Days Up to Week 2
Summary of Seizure-Free days is presented.
Measured: Up to Week 2
Number of Seizure-free Days During Week 3 Through 10
Summary of Seizure-Free days is presented.
Measured: Week 3 through Week 10
Number of Seizure-free Days During Week 1 Through 10
Summary of Seizure-Free days is presented.
Measured: Week 1 through Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2008
- Study completionNov 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 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
- NCT00465517
- Sponsor's protocol ID
- 1042-0600
- Other IDs
- V 1.3
- Status last verified
- Feb 2023
- First submitted
- 24 Apr 2007
- Last updated
- 15 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Maguire MJ, Nevitt SJ. Treatments for seizures in catamenial (menstrual-related) epilepsy. Cochrane Database Syst Rev. 2021 Sep 16;9(9):CD013225. doi: 10.1002/14651858.CD013225.pub3.
PubMed 34528245
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Subjects With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
- ClinicalTrials.gov ID
- NCT00465517
- Acronym / sponsor ID
- 1042-0600
- Conditions
- Partial Epilepsy, Catamenial Epilepsy
- Keywords
- Partial onset seizures, Complex-partial seizures, Anticonvulsant, Partial seizures, Catamenial epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Marinus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Posted 15 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.
Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ganaxolone | Experimental | Drug: Ganaxoloneactive study drug |
| non-active drug | Placebo comparator | Other: Placeboplacebo |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of epilepsy with POS with or without secondary generalized seizures according to the International League Against Epilepsy [ILAE] Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and CT or MRI of the brain to rule out progressive structural lesions and EEG with results consistent with partial-onset epilepsy.
- During the 8 week baseline period preceding randomization visit (Visit 4), participants should have a documented seizure frequency of ≥ 3CPS per 4 weeks on average.
- Participants should not be seizure free for more than 28 consecutive days during treatment with a stable dose of AEDs [Note: Participants with historically sufficiently high seizure frequency who fall short 1 seizure in any 4 weeks period or with a seizure-free period > 28 consecutive days may be allowed to enter the study after discussion with the Medical Monitor. Prolongation of the screening period for questionable cases may also be allowed by the Medical Monitor.]
- Treatment with a stable dose of up to 3 (FDA approved) current AEDs for 1 month prior to screening.
- Maintenance of current AEDs without a change in dosing for the duration of study.
Key exclusion criteria (26 listed)
- Presence of non-motor simple partial seizures only.
- History of pseudoseizures in the last 5 years.
- History of a primary generalized seizure in the last 5 years.
- Past use of vigabatrin without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (Concomitant use of vigabatrin is not allowed).
- Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or CNS disease deemed progressive, metabolic illness, or progressive degenerative disease.
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 |
|---|---|---|
| GanaxoloneOral suspension 200-500 mg 3x/day | Drug | ganaxolone |
| Placebonon-active placebo | Other | non-active drug |
Primary outcome
Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10
Time frame: Week 1 through Week 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency [including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)] during Weeks 1 through 10.
15 secondary outcomes
Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10
Time frame: Week 3 through Week 10
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Time frame: Baseline and at Week 1 through Week 10
Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Time frame: Baseline and at Week 3 through Week 10
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10
Time frame: Baseline and at Week 1 through Week 10
Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10
Time frame: Baseline and at Week 3 through Week 10
Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10
Time frame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10
Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10
Time frame: Baseline and at Week 1 through Week 10
Number of Responders During Weeks 1 Through 10
Time frame: Baseline and at Week 1 through Week 10
Number of Responders During Weeks 3 Through 10
Time frame: Baseline and at Week 3 through Week 10
Number of Seizure-free Participants Up to Week 2
Time frame: Up to Week 2
Number of Seizure-free Participants During Weeks 3 Through 10
Time frame: Week 3 through Week 10
Number of Seizure-free Participants During Weeks 1 Through 10
Time frame: Week 1 through Week 10
Number of Seizure-free Days Up to Week 2
Time frame: Up to Week 2
Number of Seizure-free Days During Week 3 Through 10
Time frame: Week 3 through Week 10
Number of Seizure-free Days During Week 1 Through 10
Time frame: Week 1 through Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34528245Maguire MJ, Nevitt SJ. Treatments for seizures in catamenial (menstrual-related) epilepsy. Cochrane Database Syst Rev. 2021 Sep 16;9(9):CD013225. doi: 10.1002/14651858.CD013225.pub3.
- information about ganaxoloneLink provided by the sponsor.
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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.
27 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 Partial Epilepsy and Catamenial Epilepsy, run by Marinus Pharmaceuticals at 27 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 15 inclusion and 26 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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. Some participants in this study may receive a placebo. 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 15 Mar 2023). 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?
Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10 (time frame: Week 1 through Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00465517, which also lists 1 linked publication.
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 15 Mar 2023.