A Phase 2 interventional study of Clobazam Low Dose and Clobazam High Dose in Epilepsy, Epilepsy, Generalized and Seizures, sponsored by Lundbeck LLC. Completed at 14 sites in United States. Open to participants aged 2 Years to 30 Years. Per ClinicalTrials.gov, last updated 2012-02-09.
Sponsored by Lundbeck LLC (part of H. Lundbeck A/S) · Phase 2, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.
This study's enrollment of 68 is close to the median of 75 across 25 interventional studies indexed under Epilepsy, Generalized.
Browse Epilepsy, Generalized studies →Lundbeck LLC is the lead sponsor of 9 studies on the registry; none are open to participants now.
Compared within Epilepsy, Generalized, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Epilepsy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Clobazam Low Dose
Drug: Clobazam High Dose
5 to 10 mg/day with doses in the morning and at bedtime; orally
Also known as: Onfi™
5 to 40 mg/day with doses in the morning and at bedtime; orally
Also known as: Onfi™
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.
Time frame: 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.
Time frame: 4-week baseline period and the 4-week maintenance period
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.
Time frame: 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".
Time frame: 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".
Time frame: Week 7
| Milestone | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| Started | 32 | 36 |
| Completed | 28 | 30 |
| Not completed | 4 | 6 |
| Withdrew: Adverse event | 2 | 5 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Physician decision | 1 | 0 |
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.
| Percent Reduction | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| Percent Reduction in Number of Drop Seizures. | 10.1 ± 122.3 | 85.2 ± 17.1 |
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.
| Percent of participants | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| ≥ 25% reduction | 18 | 32 |
| ≥ 50% reduction | 12 | 30 |
| ≥ 75% reduction | 7 | 23 |
| 100% reduction | 2 | 8 |
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".
| participants | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| Very Much Improved | 7 | 15 |
| Much Improved | 9 | 15 |
| Minimally Improved | 9 | 1 |
| No Change | 3 | 0 |
| Minimally Worse | 0 | 1 |
| Much Worse | 1 | 0 |
| Very Much Worse | 0 | 0 |
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.
| Percent Reduction | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures. | 29 (-531 to 100) | 93 (48 to 100) |
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".
| participants | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| Very Much Improved | 6 | 16 |
| Much Improved | 6 | 11 |
| Minimally Improved | 10 | 1 |
| No Change | 5 | 0 |
| Minimally Worse | 1 | 1 |
| Much Worse | 0 | 0 |
| Very Much Worse | 0 | 0 |
Collected over Up to 15 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Clobazam Low Dose | — | 1/32 (3.1%) | 27/32 (84.4%) |
| Clobazam High Dose | — | 3/36 (8.3%) | 31/36 (86.1%) |
| Event | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| Sleep Apnea SyndromeRespiratory, thoracic and mediastinal disorders | 1/32 | 0/36 |
| ConstipationGastrointestinal disorders | 0/32 | 1/36 |
| PyrexiaGeneral disorders | 0/32 | 1/36 |
| AspirationRespiratory, thoracic and mediastinal disorders | 0/32 | 1/36 |
| Respiratory DistressRespiratory, thoracic and mediastinal disorders | 0/32 | 1/36 |
| Event | Clobazam Low Dose | Clobazam High Dose |
|---|---|---|
| SomnolenceNervous system disorders | 4/32 | 7/36 |
| Otitis mediaInfections and infestations | 4/32 | 0/36 |
| LethargyNervous system disorders | 3/32 | 4/36 |
| NasopharyngitisInfections and infestations | 0/32 | 4/36 |
| Viral infectionInfections and infestations | 0/32 | 4/36 |
| ConvulsionNervous system disorders | 3/32 | 1/36 |
| Gastroenteritis viralInfections and infestations | 3/32 | 0/36 |
| Upper respiratory tract infectionInfections and infestations | 3/32 | 1/36 |
| AggressionPsychiatric disorders | 2/32 | 3/36 |
| ConstipationGastrointestinal disorders | 1/32 | 3/36 |
| Age, Categorical(Participants) | Clobazam Low Dose | Clobazam High Dose | Total |
|---|---|---|---|
| <=18 years | 30 | 33 | 63 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Clobazam Low Dose | Clobazam High Dose | Total |
|---|---|---|---|
| Mean | 9.18 ± 5.37 | 8.51 ± 5.14 | 8.82 ± 5.22 |
| Sex: Female, Male(Participants) | Clobazam Low Dose | Clobazam High Dose | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 19 | 23 | 42 |
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Clobazam