EpilepsyPhase 2NCT00162981
Clobazam in Subjects With Lennox-Gastaut Syndrome
A Phase 2 study testing Clobazam Low Dose and Clobazam High Dose in people with Epilepsy and Epilepsy, Generalized, run by Lundbeck LLC at 14 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. Read more about this study
- Who is it for?
- Ages 2 to 30 years
- Conditions the study is for
- Epilepsy, Epilepsy, Generalized, Seizures
- What is being tested?
- Clobazam Low Dose and Clobazam High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2005to Oct 2006
- 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 2 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject must have been <11 years of age at the onset of LGS
- Subject must have LGS
- Subject must be on at least 1 stable dose AED
- Parent or caregiver must be able to keep an accurate seizure diary
Who cannot join
- Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation
- Subject has had an episode of status epilepticus within 12 weeks of baseline
- Subject has had an anoxic episode requiring resuscitation within 1 year of screening
- Subject has had a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines
- Subject is taking more than 3 concurrent AEDs. Note: Vagal Nerve Stimulation (VNS) or ketogenic diet is allowed and each will be counted as one of the three allowed AEDs
- If the subject is on the ketogenic diet, has been for less than 4 weeks prior to screening or suffers from frequent stooling
Show all 10Show fewer
- If the subject has a VNS, the settings have not been stable for at least 4 weeks prior to screening
- Subject has taken corticotropins in the 6 months prior to screening
- Subject is currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for urinary tract infections or asthma
- If the subject is taking felbamate, has been taking it for less than 1 year prior to screening or previous treatment with felbamate resulted in withdrawal due to liver or bone marrow adverse events
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Childrens Hospital Boston
Boston, Massachusetts, 02115
Children's Hospital
Columbus, Ohio, 43205
Dallas Pediatric Neurology Associates
Dallas, Texas, 75230
Childrens Hospital Los Angeles
Los Angeles, California, 90027
University of Tennessee Health Science Center
Memphis, Tennessee, 38105
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
Monarch Medical Research
Norfolk, Virginia, 23510
Barrow Neurological Institute
Phoenix, Arizona, 85013
Texas Child Neurology, LLP
Plano, Texas, 75075
Virginia Commonwealth University
Richmond, Virginia, 23298
Minnesota Epilepsy Group, P.A.
Saint Paul, Minnesota, 55102
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida, 33609
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
Read the detailed description
LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment.
More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.
- Conditions
- Epilepsy, Epilepsy, Generalized, Seizures
- Being tested
- Clobazam Low Dose, Clobazam High Dose
- Medical subject headings
- Epilepsy, Epilepsy, Generalized, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clobazam Low DoseDrug
Also called Onfi™
5 to 10 mg/day with doses in the morning and at bedtime; orally
Clobazam High DoseDrug
Also called Onfi™
5 to 40 mg/day with doses in the morning and at bedtime; orally
| Study group | Role | What they receive |
|---|---|---|
| Clobazam Low Dose | Experimental | Not described Receives: Drug: Clobazam Low Dose |
| Clobazam High Dose | Experimental | Not described Receives: Drug: Clobazam High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction in Number of Drop Seizures.
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Measured: 4-week baseline period and 4-week maintenance period
A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Measured: 4-week baseline period and the 4-week maintenance period
Secondary outcomes (3)
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
Measured: 4-week baseline period and 4-week maintenance period
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".
Measured: Week 3
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
The parent/caregiver was asked to rate the patient's overall change in symptoms and overall change in seizure activity and Quality of Life since the beginning of clobazam treatment by checking "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionAug 2006
- Study completionOct 2006
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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundbeck LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162981
- Sponsor's protocol ID
- 13108A
- Other IDs
- OV1002
- Status last verified
- Jan 2012
- First submitted
- 9 Sep 2005
- Last updated
- 9 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Conry JA, Ng YT, Paolicchi JM, Kernitsky L, Mitchell WG, Ritter FJ, Collins SD, Tracy K, Kormany WN, Abdulnabi R, Riley B, Stolle J. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia. 2009 May;50(5):1158-66. doi: 10.1111/j.1528-1167.2008.01935.x. Epub 2008 Dec 15.
PubMed 19170737
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Clobazam in Subjects With Lennox-Gastaut Syndrome
- ClinicalTrials.gov ID
- NCT00162981
- Acronym / sponsor ID
- 13108A
- Conditions
- Epilepsy, Epilepsy, Generalized, Seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Lundbeck LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Posted 9 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. for up to 15 weeks. Subjects will be randomly assigned to either a low dose or a high dose. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, subjects will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.
Detailed description
LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment.
More effective and better tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam is unique in that it is the only non-1, 4-benzodiazepine used in the treatment of epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clobazam Low Dose | Experimental | Drug: Clobazam Low Dose |
| Clobazam High Dose | Experimental | Drug: Clobazam High Dose |
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subject must have been <11 years of age at the onset of LGS
- Subject must have LGS
- Subject must be on at least 1 stable dose AED
- Parent or caregiver must be able to keep an accurate seizure diary
Key exclusion criteria (10 listed)
- Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation
- Subject has had an episode of status epilepticus within 12 weeks of baseline
- Subject has had an anoxic episode requiring resuscitation within 1 year of screening
- Subject has had a clinically significant history of an allergic reaction or significant sensitivity to benzodiazepines
- Subject is taking more than 3 concurrent AEDs. Note: Vagal Nerve Stimulation (VNS) or ketogenic diet is allowed and each will be counted as one of the three allowed AEDs
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 |
|---|---|---|
| Clobazam Low DoseAlso: Onfi™5 to 10 mg/day with doses in the morning and at bedtime; orally | Drug | Clobazam Low Dose |
| Clobazam High DoseAlso: Onfi™5 to 40 mg/day with doses in the morning and at bedtime; orally | Drug | Clobazam High Dose |
Primary outcome
Percent Reduction in Number of Drop Seizures.
Time frame: 4-week baseline period and 4-week maintenance period
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
Time frame: 4-week baseline period and the 4-week maintenance period
Number of drop seizures (average per week) was obtained from seizure diaries. The average drop in seizures per week for patients who did not complete the maintenance period was calculated based on the time from the beginning of the maintenance period to date of withdrawal.
3 secondary outcomes
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.
Time frame: 4-week baseline period and 4-week maintenance period
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Time frame: Week 3
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
Time frame: Week 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19170737Conry JA, Ng YT, Paolicchi JM, Kernitsky L, Mitchell WG, Ritter FJ, Collins SD, Tracy K, Kormany WN, Abdulnabi R, Riley B, Stolle J. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia. 2009 May;50(5):1158-66. doi: 10.1111/j.1528-1167.2008.01935.x. Epub 2008 Dec 15.
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
14 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 Clobazam Low Dose and Clobazam High Dose in people with Epilepsy and Epilepsy, Generalized, run by Lundbeck LLC at 14 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 4 inclusion and 10 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 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 9 Feb 2012). 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?
Percent Reduction in Number of Drop Seizures. (time frame: 4-week baseline period and 4-week maintenance period). The study lists 2 primary outcomes in all. 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 NCT00162981, 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 9 Feb 2012.