CompletedNCT00518713Updated Feb 9, 2012Results posted

Clobazam in Patients With Lennox-Gastaut Syndrome

A Phase 3 interventional study of Clobazam Low Dose and Clobazam Medium Dose in Epilepsy, Epilepsy, Generalized and Seizures, sponsored by Lundbeck LLC. Completed at 53 sites in 5 countries. Open to participants aged 2 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-02-09.

Sponsored by Lundbeck LLC (part of H. Lundbeck A/S) · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 238
Allocation: Randomized
Ages: 2 Years to 60 Years
Sex: All

Study 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 patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients 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. No single antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Even with combination therapy, many LGS patients show resistance to treatment. Adjunctive therapy with newer anticonvulsant medications has demonstrated efficacy for some patients, although polytherapy and high medication doses are often associated with unfavorable adverse event profiles.

More effective and better-tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam may provide an improved safety profile compared to other AEDs currently approved for the treatment of LGS and may have less hypotonia and drooling effects than other benzodiazepines.

Conditions studied

Epilepsy
Epilepsy, Generalized
Seizures

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Keywords

Epilepsy
Lennox-Gastaut Syndrome
Drop seizures
Clobazam

In context

Epilepsy

1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.

This study's enrollment of 238 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Lundbeck LLC is the lead sponsor of 9 studies on the registry; none are open to participants now.

Browse Lundbeck LLC studies →All H. Lundbeck A/S studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient must have been \<11 years of age at the onset of LGS.
Patient must have LGS.
Patient must be on at least 1 AED.
Parent or caregiver must be able to keep an accurate seizure diary.

Exclusion criteria

Exclusion Criteria:

Etiology of patient's seizures is a progressive neurologic disease. Patients with tuberous sclerosis will not be excluded from study participation, unless there is a progressive tumor.
Patient has had an episode of status epilepticus within 12 weeks of baseline.
Patient has had an anoxic episode requiring resuscitation within 6 months of screening.
Patient has a history of an allergic reaction or significant sensitivity to benzodiazepines.
Patient is taking more than 3 concurrent AEDs.
Patient has been on the ketogenic diet for less than 30 days prior to screening or suffers from frequent stooling.
If the patient has a Vagal Nerve Stimulator (VNS), the settings have not been stable for at least 30 days prior to screening.
Patient has taken corticotropins in the 6 months prior to screening.
Patient is currently taking long-term systemic (excluding inhaled mediation for asthma treatment) or any other daily medication known to exacerbate epilepsy. An exception will be made of prophylactic medication, for example, for idiopathic nephrotic syndrome or asthma.
If the patient is taking felbamate, has been taking it for less than 1 year prior to screening.

Other protocol-defined inclusion and exclusion criteria may apply.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 238 participants (actual)

Study arms

Experimental
Clobazam Low Dose
Drug: Clobazam Low Dose
Experimental
Clobazam Medium Dose
Drug: Clobazam Medium Dose
Experimental
Clobazam High Dose
Drug: Clobazam High Dose
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugClobazam Low Dose
0.25 mg/kg/day; tablets; orally; for 15-18 weeks
Also known as: Onfi™
DrugClobazam Medium Dose
0.5 mg/kg/day; tablets; orally; for 15-18 weeks
Also known as: Onfi™
DrugClobazam High Dose
1.0 mg/kg/day; tablets; orally; for 15-18 weeks
Also known as: Onfi™
DrugPlacebo
tablets; orally; daily for 15-18 weeks

What researchers measure

Primary outcomes

Percent Reduction in Number of Drop Seizures (12-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.
Time frame: 4-week baseline period and 12-week maintenance period

Secondary outcomes

Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-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.
Time frame: 4-week baseline period and the first 4 weeks of the 12-week maintenance period
Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-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.
Time frame: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-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.
Time frame: 4-week baseline period and the last 4 weeks of the 12-week maintenance period
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-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.
Time frame: 4-week baseline period and the 12-week maintenance period
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-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.
Time frame: 4-week baseline period and the first 4 weeks of the 12-week maintenance period
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-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.
Time frame: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-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.
Time frame: 4-week baseline period and the last 4 weeks of the 12-week maintenance period
Tolerance
Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.
Time frame: 4-week baseline period and first 4/first 8 weeks of the maintenance period
Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
The physician 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".
Time frame: Week 15
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".
Time frame: Week 15

Other outcomes

Percent Reduction in the Number of Non-drop Seizures.
This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.
Time frame: 4-week baseline period and the 12-week maintenance period
Percent Reduction of Total (Drop and Non-Drop) Seizures.
This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.
Time frame: 4-week baseline period and 12-week maintenance period

Results

Posted Feb 9, 2012

Participant flow

Participant flow — Overall Study
Milestone	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Started	58	62	59	59
Modified intent-to-treat population	53	58	49	57
Completed	50	45	41	41
Not completed	8	17	18	18

Outcome measures

PrimaryPercent Reduction in Number of Drop Seizures (12-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.

Time frame:: 4-week baseline period and 12-week maintenance period
Reported as:: Least squares mean · Percent Reduction

Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).
Percent Reduction	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).	41.2 (-119 to 100)	49.4 (-262 to 100)	68.3 (-39 to 100)	12.1 (-374 to 100)

Statistical analysis

Clobazam Low Dose vs Placebo · ANCOVA · p = 0.0120
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.0015
Clobazam High Dose vs Placebo · ANCOVA · p = <0.0001

SecondaryPercent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).

Time frame:: 4-week baseline period and the first 4 weeks of the 12-week maintenance period
Reported as:: Least squares mean · Percent reduction

Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
Percent reduction	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).	47.8 (-103 to 100)	58.9 (-147 to 100)	71.0 (-58 to 100)	18.6 (-106 to 100)

Statistical analysis

Clobazam Low Dose vs Placebo · ANCOVA · p = 0.0027
Clobazam Medium Dose vs Placebo · ANCOVA · p = <0.0001
Clobazam High Dose vs Placebo · ANCOVA · p = <0.0001

SecondaryPercent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).

Time frame:: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Reported as:: Least squares mean · Percent reduction

Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
Percent reduction	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).	44.1 (-36 to 100)	38.8 (-433 to 100)	64.9 (-125 to 100)	21.1 (-284 to 100)

Statistical analysis

Clobazam Low Dose vs Placebo · ANCOVA · p = 0.1041
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.2207
Clobazam High Dose vs Placebo · ANCOVA · p = 0.0025

SecondaryPercent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).

Time frame:: 4-week baseline period and the last 4 weeks of the 12-week maintenance period
Reported as:: Least squares mean · Percent reduction

Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
Percent reduction	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Percent Reduction in Number of Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).	31.8 (-477 to 100)	56.0 (-228 to 100)	68.0 (-117 to 100)	-0.1 (-948 to 100)

Statistical analysis

Clobazam Low Dose vs Placebo · ANCOVA · p = 0.1469
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.0161
Clobazam High Dose vs Placebo · ANCOVA · p = 0.0024

SecondaryPercent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).

Time frame:: 4-week baseline period and the 12-week maintenance period
Reported as:: Number · Percent of responders

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (12-week Maintenance Period).
Percent of responders	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
≥ 25% reduction	34 (0.83 to 4.20)	46 (1.61 to 9.59)	41 (2.14 to 14.30)	28
≥ 50% reduction	23	34	38	18
≥ 75% reduction	15	22	31	6
100% reduction	4	7	12	2

Statistical analysis

Clobazam Low Dose vs Placebo · ANCOVA · p = 0.1324
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.0026
Clobazam High Dose vs Placebo · ANCOVA · p = 0.0004
Clobazam Low Dose vs Placebo · ANCOVA · p = 0.3383
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.0159
Clobazam High Dose vs Placebo · ANCOVA · p = <0.0001
Clobazam Low Dose vs Placebo · ANCOVA · p = 0.0279
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.0010
Clobazam High Dose vs Placebo · ANCOVA · p = <0.0001

SecondaryPercent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).

Time frame:: 4-week baseline period and the first 4 weeks of the 12-week maintenance period
Reported as:: Number · Percent of responders

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
Percent of responders	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
≥ 25% reduction	71.7	82.8	89.8	52.6
≥ 50% reduction	47.2	72.4	77.6	31.6
≥ 75% reduction	35.8	44.8	63.3	14.0
100% reduction	13.2	19.0	30.6	3.5

SecondaryPercent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).

Time frame:: 4-week baseline period and the middle 4 weeks of the 12-week maintenance period
Reported as:: Number · Percent Responders

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
Percent Responders	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
≥ 25% reduction	64.2	65.5	75.5	50.9
≥ 50% reduction	43.4	51.7	71.4	24.6
≥ 75% reduction	28.3	34.5	59.2	12.3
100% reduction	9.4	15.5	26.5	5.3

SecondaryPercent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).

Time frame:: 4-week baseline period and the last 4 weeks of the 12-week maintenance period
Reported as:: Number · Percent Responders

Percent of Patients Considered Treatment Responders Defined as Those With a >=25%, >=50%, >=75%, 100% Reduction in Drop Seizures (Last 4 Weeks of the 12-week Maintenance Period).
Percent Responders	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
≥ 25% reduction	66.0	60.3	71.4	43.9
≥ 50% reduction	45.3	50.0	67.3	29.8
≥ 75% reduction	28.3	36.2	57.1	12.3
100% reduction	13.2	15.5	20.4	5.3

SecondaryTolerance

Study responders who have ≥50% reduction in their drop seizure rate during the first 4 or first 8 weeks of maintenance compared to the 4 week baseline period.

Time frame:: 4-week baseline period and first 4/first 8 weeks of the maintenance period
Reported as:: Number · Participants

Tolerance
Participants	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
≥ 50% reduction - first 4 weeks of maintenance	25	42	38	18
≥ 50% reduction - first 8 weeks of maintenance	23	38	38	20

SecondaryInvestigator Global Evaluations of the Patient's Overall Change in Symptoms.

The physician 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".

Time frame:: Week 15
Reported as:: Number · participants

Investigator Global Evaluations of the Patient's Overall Change in Symptoms.
participants	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Very much improved	4	10	8	3
Much improved	20	27	23	10
Minimally improved	13	9	8	13
No change	12	9	6	22
Minimally worse	2	2	3	6
Much worse	1	0	1	1
Very much worse	0	0	0	0

SecondaryParent/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".

Time frame:: Week 15
Reported as:: Number · participants

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
participants	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Very much improved	8	13	11	4
Much improved	14	19	18	10
Minimally improved	20	14	11	11
No change	8	7	4	21
Minimally worse	2	2	3	6
Much worse	0	2	2	3
Very much worse	1	0	0	0

Other pre-specifiedPercent Reduction in the Number of Non-drop Seizures.

This outcome measure evaluated the percent reduction (average per week) in non-drop Seizures. Non-drop seizures were other seizures not meeting the drop seizure definition. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell.

Time frame:: 4-week baseline period and the 12-week maintenance period
Reported as:: Least squares mean · Percent reduction

Percent Reduction in the Number of Non-drop Seizures.
Percent reduction	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Percent Reduction in the Number of Non-drop Seizures.	-53.3 (-1627 to 100)	-3.3 (-1591 to 100)	40.0 (-190 to 100)	-76.3 (-1477 to 97)

Statistical analysis

Clobazam Low Dose vs Placebo · ANCOVA · p = 0.7210
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.2505
Clobazam High Dose vs Placebo · ANCOVA · p = 0.0924

Other pre-specifiedPercent Reduction of Total (Drop and Non-Drop) Seizures.

This outcome measure evaluated the percent reduction in average weekly rate in total (drop and non-drop) seizures. Drop seizures were defined as a drop attack or spell (atonic, tonic or myoclonic) involving the entire body, trunk, or head that led to a fall, injury, slumping in chair, or head hitting surface or that could have led to a fall or injury, depending on the position of the patient at the time of the attack or spell. Non-drop seizures were other seizures not meeting the drop seizure definition.

Time frame:: 4-week baseline period and 12-week maintenance period
Reported as:: Least squares mean · Percent reduction

Percent Reduction of Total (Drop and Non-Drop) Seizures.
Percent reduction	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
Percent Reduction of Total (Drop and Non-Drop) Seizures.	34.8 (-155 to 100)	45.3 (-523 to 100)	65.3 (-49 to 100)	9.3 (-189 to 100)

Statistical analysis

Clobazam Low Dose vs Placebo · ANCOVA · p = 0.0414
Clobazam Medium Dose vs Placebo · ANCOVA · p = 0.0044
Clobazam High Dose vs Placebo · ANCOVA · p = <0.0001

Adverse events

Collected over 19 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Clobazam Low Dose	—	3/58 (5.2%)	42/58 (72.4%)
Clobazam Medium Dose	—	6/62 (9.7%)	55/62 (88.7%)
Clobazam High Dose	—	5/59 (8.5%)	45/59 (76.3%)
Placebo	—	2/59 (3.4%)	40/59 (67.8%)

Most frequent serious events

Showing 10 of 22

Most frequent serious events
Event	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
PneumoniaInfections and infestations	2/58	2/62	1/59	0/59
Lobar pneumoniaInfections and infestations	0/58	0/62	2/59	1/59
Adverse drug reactionGeneral disorders	1/58	0/62	0/59	0/59
SedationNervous system disorders	1/58	0/62	0/59	0/59
Metapneumovirus infectionInfections and infestations	1/58	0/62	0/59	0/59
Rhinovirus infectionInfections and infestations	1/58	0/62	0/59	0/59
Jaw fractureInjury, poisoning and procedural complications	0/58	0/62	0/59	1/59
InfluenzaInfections and infestations	0/58	0/62	1/59	0/59
Parainfluenzae virus infectionInfections and infestations	0/58	0/62	1/59	0/59
Depressed level of consciousnessPsychiatric disorders	0/58	0/62	1/59	0/59

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo
SomnolenceNervous system disorders	9/58	15/62	15/59	7/59
PyrexiaGeneral disorders	10/58	6/62	7/59	2/59
LethargyNervous system disorders	6/58	3/62	9/59	3/59
Upper respiratory tract infectionInfections and infestations	6/58	8/62	8/59	6/59
DroolingNervous system disorders	0/58	8/62	8/59	2/59
AggressionPsychiatric disorders	2/58	5/62	8/59	3/59
IrritabilityGeneral disorders	2/58	7/62	3/59	3/59
ConstipationGastrointestinal disorders	1/58	1/62	6/59	0/59
NasopharyngitisInfections and infestations	5/58	6/62	4/59	6/59
AtaxiaNervous system disorders	2/58	1/62	6/59	2/59

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo	Total
<=18 years	48	48	49	48	193
Between 18 and 65 years	10	14	10	11	45
>=65 years	0	0	0	0	0

Age Continuous
Age Continuous(years)	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo	Total
Mean	10.9 ± 7.24	14.1 ± 10.42	11.7 ± 8.48	13.0 ± 9.17	12.4 ± 8.96

Sex: Female, Male
Sex: Female, Male(Participants)	Clobazam Low Dose	Clobazam Medium Dose	Clobazam High Dose	Placebo	Total
Female	22	26	25	21	94
Male	36	36	34	38	144

Study locations

53 sites

University of Alabama at Birmingham
Huntsville, Alabama 35081, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013, United States
Phoenix Children's Hospital
Phoenix, Arizona 85216, United States
Childrens Hospital Los Angeles
Los Angeles, California 90027, United States
The Children's Hospital
Aurora, Colorado 80045, United States
Children's National Medical Center
Washington, District of Columbia 20010, United States
Pediatric Neurology and Epilepsy Center
Loxahatchee, Florida 33470, United States
Child Neurology Center of NW FL
Pensacola, Florida 32504, United States
University of South Florida
Tampa, Florida 33606, United States
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida 33609, United States
Medical College of Georgia
Augusta, Georgia 30912, United States
Pediatric Neurology of Idaho Children's Specialty Center
Boise, Idaho 83712, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
University of Chicago Medical Center
Chicago, Illinois 60637, United States
Children's Memorial Hospital
Chicago, Illinois 61516, United States
University of Kentucky, Kentucky Clinic, Department of Neurology
Lexington, Kentucky 40536-0284, United States
LSU Health Sciences Center
Shreveport, Louisiana 71103, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Minnesota Epilepsy Group
St. Paul, Minnesota 55012, United States
The Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri 63017, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire 03756, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey 07503, United States
Clinical Research Center of New Jersey (CRCNJ)
Voorhees, New Jersey 08043, United States
University of Rochester Medical Center
Rochester, New York 14450, United States
University Neurology, Inc.
Cincinnati, Ohio 45219, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104, United States
Jefferson Epilepsy Center
Philadelphia, Pennsylvania 19107, United States
UTMG Pediatric Neurology
Memphis, Tennessee 38105, United States
Children's Medical Center at UT Southwestern-Dallas
Dallas, Texas 75235, United States
Cook Children's Health Care System
Fort Worth, Texas 76104, United States
Baylor College of Medicine Pediatric Neurology
Houston, Texas 77030, United States
Virginia Commonwealth University
Richmond, Virginia 23298-0211, United States
Strategic Health Evaluators
Chatswood, New South Wales 2067, Australia
Royal Melbourne Hospital Department of Neurology
Melbourne, Victoria 3050, Australia
Austin & Repatriation Hospital (Austin Health) Epilepsy Research Centre
Melbourne, Victoria 3081, Australia
Vitebsk Regional Diagnostic Center
Vitebsk, 210023, Belarus
Maulana Azad Medical College and Associated Lok Nayak Govind Ballabh Pant Hospitals and Guru Nanak Eye centre
New Delhi, Delhi 110002, India
Neurology Center
Ahmedabad, Gujarat 380006, India
St. John's Medical College Hospital
Bangalore, Karnataka 560034, India
Malikatta Neuro Center
Mangalore, Karnataka 575002, India
K. S. Hedge Medical Academy
Mangalore, Karnataka 575018, India
Jaslok Hospital & Research Centre
Mumbai, Maharashtra 400026, India
KEM Hospital & Research Centre
Pune, Maharashtra 411 011, India
Institute of Human Behaviour and Allied Sciences
Delhi, New Delhi 110095, India
Deenanath Mangeshkar Hospital and Research Center
Erandawane, Pune 411004, India
Christian Medical College
Ludhiana, Punjab 1410108, India
Dr. Kamakshi Memorial Hospital
Chennai, Tamilnadu 600 100, India
Chhatrapati Sahu Ji Maharaj Medical University
Lucknow, Uttra Pradesh 226 003, India
Apollo Gleneagles Hospitals
Kolkata, West Bengal 700054, India
P.D. Hinduja National Hospital Medical Research Centre
Mumbai, 400016, India
Kaunas University of Medicine Hospital
Kaunas, LT 50009, Lithuania

References and documents

Publications

Ng YT, Conry JA, Drummond R, Stolle J, Weinberg MA; OV-1012 Study Investigators. Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology. 2011 Oct 11;77(15):1473-81. doi: 10.1212/WNL.0b013e318232de76. Epub 2011 Sep 28. PubMed 21956725 ↗
Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4. PubMed 33825230 ↗
Gidal BE, Wechsler RT, Sankar R, Montouris GD, White HS, Cloyd JC, Kane MC, Peng G, Tworek DM, Shen V, Isojarvi J. Deconstructing tolerance with clobazam: Post hoc analyses from an open-label extension study. Neurology. 2016 Oct 25;87(17):1806-1812. doi: 10.1212/WNL.0000000000003253. Epub 2016 Sep 28. PubMed 27683846 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00518713
Lead sponsor: Lundbeck LLC
Responsible party: Sponsor
First posted: Aug 21, 2007
Start date: Aug 2007
Primary completion: Dec 2009
Completion: Apr 2010
Results posted: Feb 9, 2012
Last update: Feb 9, 2012

Study contacts

Email contact via H. Lundbeck A/S

study director · LundbeckClinicalTrials@lundbeck.com

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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Clobazam in Patients With Lennox-Gastaut Syndrome

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