EpilepsyPhase 4NCT00630630
Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy
A Phase 4 study testing Levetiracetam in people with Epilepsy, run by UCB Pharma.
Trial summary
The relationship between hormone cycling/fluctuations and the occurrence of seizures in women has received considerable discussion in the medical literature. This study investigated the efficacy and tolerability of LEV treatment for subjects with catamenial exacerbation of partial onset seizures. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Epilepsy
- What is being tested?
- Levetiracetam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Nov 2003
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Non-pregnant and non-nursing females between the ages of 18 - 45 years of age;
- out-patients with epilepsy experiencing uncontrolled simple and/or complex partial seizures with or without secondary generalization for a minimum of 2 years;
- classifiable epilepsy according to the International Classification of Epileptic Seizures;
- minimum of 2 seizures per 4 weeks during the Baseline Period, without exceeding 100 seizures per 4 weeks. The majority of seizures (>50%) must be partial onset, with or without secondary generalization;
- exhibited, during the Baseline Period, a catamenial epilepsy type C1 pattern defined as at least a 70% increase of weekly seizure frequency during the menstrual phase compared to the luteal and follicular phases combined;
- concurrent C2 catamenial epilepsy, defined as a 70% increase in daily seizure average during the ovulatory phase in comparison to the follicular and luteal phases combined, was permitted;
- taking a minimum of one and a maximum of two antiepileptic drugs at a stable dose for a period of 4 weeks prior to the selection visit and during the duration of the trial;
- vagal nerve stimulator (VNS) was permitted.
Who cannot join
- using felbatol and presented clinically significant abnormalities with WBCs, RBCs, platelets, and/or hepatic function during felbatol treatment, and taking felbatol less than one year from the date of the Selection Visit;
- partial onset seizures uncountable due to clustering during the last 3 months;
- hormonal contraceptives that block menses within 6 months of the selection visit with no washout period permitted;
- menstrual cycle length less than 21 days and greater than 35 days during the baseline evaluation;
- alternative medications documented or purported to impact reproductive hormone levels, within the prior 2 months with no washout period permitted;
- significantly irregular menstrual cycles or a history of frequent amenorrhea defined as two episodes within the preceding 6 months;
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- not taking hormonal contraceptives with more than one anovulatory cycle during the Baseline Period;
- clinically significant medical condition requiring treatment, except for the study indication, which would prevent clear interpretation of the study results;
- using the following classes of medications influencing the central nervous system: antipsychotics (typical and atypical), psychostimulants (except those containing methylphenidate, dextroamphetamine, or amphetamine used in the treatment of Attention Deficit Disorder), and hypnotics;
- chronically dosing with benzodiazepines;
- hospitalized for depression within 3 months prior to the selection visit.
- history of attempting suicide within the last 3 years, or suicidal ideation within the last 3 months;
- recent history (within the past two years) or presence of significant alcohol abuse or drug abuse;
- clinical history of significantly impaired renal function with a estimate of creatinine clearance below 80 ml/min;
- history of clinically significant cardiac conditions;
- ALT/SGPT, AST/SGOT, alkaline phosphatase, or ?-GT value of more than 3 times the upper limit of the central laboratory reference value;
- presence of a terminal illness;
- presence of any clinically significant allergic condition to levetiracetam or pyrrolidone derivatives;
- neutrophil count of less than 1800 per ?L.
About this study
Official title: A Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Adult Female Subjects (18 to 40 Years of Age) With C1 Catamenial Epilepsy
The relationship between hormone cycling/fluctuations and the occurrence of seizures in women has received considerable discussion in the medical literature. This study investigated the efficacy and tolerability of LEV treatment for subjects with catamenial exacerbation of partial onset seizures.
- Conditions
- Epilepsy
- Being tested
- Levetiracetam, Placebo
- Keywords
- Levetiracetam, Keppra
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra, ucbL059
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Levetiracetam |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in catamenial seizure frequency.
Secondary outcomes (8)
Responder rate
Number of days free from seizures per week
Ratio of catamenial seizure frequency to non-catamenial seizure frequency
Catamenial seizure frequency during each cycle
Seizure frequency of catamenial and non-catamenial combined
Non-catamenial seizure frequency
Catamenial seizure frequency separately for ovulatory and anovulatory cycles
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startNov 2002
- Primary completionNov 2003
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630630
- Sponsor's protocol ID
- N01088
- Status last verified
- Sep 2009
- First submitted
- 27 Feb 2008
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Adult Female Subjects (18 to 40 Years of Age) With C1 Catamenial Epilepsy
- ClinicalTrials.gov ID
- NCT00630630
- Acronym / sponsor ID
- N01088
- Conditions
- Epilepsy
- Keywords
- Levetiracetam, Keppra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Nov 2003 (actual)
- Study completion
- Nov 2003 (actual)
- First posted
- 7 Mar 2008 (estimated)
- 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.
The relationship between hormone cycling/fluctuations and the occurrence of seizures in women has received considerable discussion in the medical literature. This study investigated the efficacy and tolerability of LEV treatment for subjects with catamenial exacerbation of partial onset seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levetiracetam |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Non-pregnant and non-nursing females between the ages of 18 - 45 years of age;
- out-patients with epilepsy experiencing uncontrolled simple and/or complex partial seizures with or without secondary generalization for a minimum of 2 years;
- classifiable epilepsy according to the International Classification of Epileptic Seizures;
- minimum of 2 seizures per 4 weeks during the Baseline Period, without exceeding 100 seizures per 4 weeks. The majority of seizures (>50%) must be partial onset, with or without secondary generalization;
- exhibited, during the Baseline Period, a catamenial epilepsy type C1 pattern defined as at least a 70% increase of weekly seizure frequency during the menstrual phase compared to the luteal and follicular phases combined;
Key exclusion criteria (19 listed)
- using felbatol and presented clinically significant abnormalities with WBCs, RBCs, platelets, and/or hepatic function during felbatol treatment, and taking felbatol less than one year from the date of the Selection Visit;
- partial onset seizures uncountable due to clustering during the last 3 months;
- hormonal contraceptives that block menses within 6 months of the selection visit with no washout period permitted;
- menstrual cycle length less than 21 days and greater than 35 days during the baseline evaluation;
- alternative medications documented or purported to impact reproductive hormone levels, within the prior 2 months with no washout period permitted;
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 |
|---|---|---|
| LevetiracetamAlso: Keppra, ucbL059 | Drug | 1 |
| Placebo | Other | 2 |
Primary outcome
Percent change in catamenial seizure frequency.
8 secondary outcomes
Responder rate
Number of days free from seizures per week
Ratio of catamenial seizure frequency to non-catamenial seizure frequency
Catamenial seizure frequency during each cycle
Seizure frequency of catamenial and non-catamenial combined
Non-catamenial seizure frequency
Catamenial seizure frequency separately for ovulatory and anovulatory cycles
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levetiracetam in people with Epilepsy, run by UCB Pharma.
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 8 inclusion and 19 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 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change in catamenial seizure frequency.. 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 26 Nov 2013.