Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01160770
• Date of registration: 18/06/2010
• Prospective Registration: No
• Primary sponsor: Lundbeck LLC
• Public title: Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome LGS
• Scientific title: Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome
• Date of first enrolment: December 2005
• Target sample size: 267
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01160770
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

Inclusion Criteria:

- The subject or subject's legally authorized representative (LAR) must sign and date
the institutional review board (IRB)/independent ethics committee (IEC) approved
Informed Consent Form/Health Insurance Portability and Accountability Act (HIPAA)
Authorization (if required) prior to study participation.

- Previous participation in Lundbeck-sponsored LGS study.

- Subject must weigh =12.5 kilograms.

- Male or female subjects must have been between 2 and 60 years of age at the time of
the enrollment in the Phase 3 double-blind study (13110A/OV1012/NCT00518713) or
between 2 and 30 years of age at the time of the enrollment in the Phase 2
double-blind study (13108A/OV1002/NCT00162981) study.

- If female:

- Subject is either not of childbearing potential, defined as premenarchal,
postmenopausal for at least 1 year or surgically sterile (bilateral tubal
ligation, bilateral oophorectomy or hysterectomy), or if of childbearing
potential, must comply with a method of birth control acceptable to the
investigator during the study, for at least 4 weeks prior to study entry and for
4 weeks following completion of the study.

- Subject is not breastfeeding.

- Subjects of childbearing potential must have a negative serum pregnancy test at
Study Day 1.

- In the investigator's opinion, parent or caregiver must be able to keep an accurate
seizure diary.

Exclusion Criteria:

- Greater than 14 days have elapsed since the subject received his/her last dose of
study medication in the previous Lundbeck-sponsored LGS study.

- Subject had a serious or severe adverse event in the previous Lundbeck-sponsored LGS
study that in the opinion of the investigator was probably or definitely related to
clobazam use and precludes safe use of clobazam.

- Subject has had an anoxic episode requiring resuscitation within 6 months of study
entry.

- Subject has a history of an allergic reaction or significant sensitivity to
benzodiazepines or to any of the other ingredients in clobazam tablets.

- Subject is taking more than 3 concurrent anti-epileptic drugs (AEDs). NOTE: Vagal
Nerve Stimulator (VNS) or ketogenic diet is allowed and will not be counted in the
three allowed AEDs.

- 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 idiopathic
nephrotic syndrome or asthma.

- If the subject is taking felbamate, has been taking it for less than 1 year prior to
study entry or previous treatment with felbamate resulted in withdrawal due to liver
or bone marrow adverse events.

- Subject has experienced an idiosyncratic reaction to an AED, e.g., carbamazepine with
resulting aplastic anemia or agranulocytosis, topiramate with resulting metabolic
acidosis, felbamate with resulting aplastic anemia or hepatic failure, or lamotrigine
with resulting skin irritation and/or rash.

- Subject has shown any clinically significant history of hyper-sensitivity to central
nervous system (CNS) active medications leading to neurobehavioral aberrations (e.g.,
increased biting, scratching, kicking, or hitting).

- Subject has taken or used any investigational drug or device in the 30 days prior to
screening, with the exception of clobazam in a Lundbeck-sponsored study.

- Subject has a clinically significant unstable hepatic, hematological, renal,
cardiovascular, gastrointestinal, or pulmonary disease or ongoing malignancy.

- Subject has a diagnosis of sleep apnea.

- Subject has a compromised respiratory function or severe respiratory insufficiency.

- Subject has a history of severe muscle weakness, including myasthenia gravis.

- Subject has a clinically significant abnormal laboratory value or electrocardiogram
(ECG) abnormality.

- Subject has progressive lesion confirmed by magnetic resonance imaging (MRI) or
computed tomography (CT) scan.

- Subject has a history of drug or alcohol abuse.

- Subject has a history of poor compliance on past antiepileptic therapy.

- Subject has inadequate supervision by parent or guardian.

- For any reason, the subject is considered by the investigator to be an unsuitable
candidate for the study.



Age minimum: 2 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lennox-Gastaut Syndrome

Intervention(s)

Drug: Clobazam

Primary Outcome(s)

Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment [Time Frame: Baseline to month 36]

Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment [Time Frame: Baseline to month 36]

Secondary Outcome(s)

Percent of Patients Considered Treatment Responders Defined as Those With a =25%, =50%, =75%, 100% Reduction in Drop Seizures Based on the Last 30-day Assessment [Time Frame: Baseline to month 36]

Investigator Global Evaluations of the Patient's Overall Change in Symptoms [Time Frame: Baseline to month 36]

Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms [Time Frame: Baseline to month 36]

Percent of Patients Considered Treatment Responders Defined as Those With a =25%, =50%, =75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment [Time Frame: Baseline to month 36]

Secondary ID(s)

13109A

OV1004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/05/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01160770