Trial Outcomes & Findings for Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome (NCT NCT01160770)
NCT ID: NCT01160770
Last Updated: 2018-03-21
Results Overview
Number of drop seizures was obtained from seizure diaries
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
267 participants
Primary outcome timeframe
Baseline to month 36
Results posted on
2018-03-21
Participant Flow
Subjects enrolled in the LGS studies 13108A/OV1002/NCT00162981 or 13110A/OV1012/NCT00518713 sponsored by Lundbeck LLC who either completed the study or who prematurely discontinued will have the opportunity to rollover into this open-label study.
Participant milestones
| Measure |
Clobazam
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Overall Study
STARTED
|
267
|
|
Overall Study
COMPLETED
|
188
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
Clobazam
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Subject/parent/caregiver request
|
33
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Study termination or sponsor request
|
1
|
|
Overall Study
Death
|
9
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Other Reasons
|
1
|
Baseline Characteristics
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome
Baseline characteristics by cohort
| Measure |
Clobazam
n=267 Participants
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Age, Continuous
|
11.3 years
STANDARD_DEVIATION 7.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to month 36Number of drop seizures was obtained from seizure diaries
Outcome measures
| Measure |
Clobazam
n=113 Participants
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment
|
92.3 percentage of drop seizures
Interval -588.0 to 100.0
|
PRIMARY outcome
Timeframe: Baseline to month 36Number of drop seizures was obtained from seizure diaries
Outcome measures
| Measure |
Clobazam
n=121 Participants
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment
|
92.7 percentage of drop seizures
Interval -752.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline to month 36Number of drop seizures obtained from seizure diaries
Outcome measures
| Measure |
Clobazam
n=113 Participants
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
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
Any reduction
|
85.8 percentage of participants
|
|
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
≥25% reduction
|
82.3 percentage of participants
|
|
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
≥50% reduction
|
77.9 percentage of participants
|
|
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
≥75% reduction
|
64.6 percentage of participants
|
|
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
100% reduction
|
38.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to month 36Number of drop seizures obtained from seizure diaries
Outcome measures
| Measure |
Clobazam
n=121 Participants
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
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
Any reduction
|
86.0 percentage of participants
|
|
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
≥25% reduction
|
83.5 percentage of participants
|
|
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
≥50% reduction
|
79.3 percentage of participants
|
|
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
≥75% reduction
|
64.5 percentage of participants
|
|
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
100% reduction
|
31.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to month 36The physician was asked to rate the patient's overall change in symptoms 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".
Outcome measures
| Measure |
Clobazam
n=137 Participants
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms
VERY MUCH IMPROVED
|
35.0 percentage of participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms
MUCH IMPROVED
|
45.3 percentage of participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms
MINIMALLY IMPROVED
|
14.6 percentage of participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms
NO CHANGE
|
2.2 percentage of participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms
MINIMALLY WORSE
|
0.7 percentage of participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms
MUCH WORSE
|
1.5 percentage of participants
|
|
Investigator Global Evaluations of the Patient's Overall Change in Symptoms
VERY MUCH WORSE
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to month 36The parent/caregiver was asked to rate the patient's overall change in symptoms 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".
Outcome measures
| Measure |
Clobazam
n=137 Participants
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms
VERY MUCH IMPROVED
|
45.3 percentage of participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms
MUCH IMPROVED
|
35.0 percentage of participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms
MINIMALLY IMPROVED
|
11.7 percentage of participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms
NO CHANGE
|
3.6 percentage of participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms
MINIMALLY WORSE
|
1.5 percentage of participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms
MUCH WORSE
|
2.9 percentage of participants
|
|
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms
VERY MUCH WORSE
|
0.0 percentage of participants
|
Adverse Events
Clobazam
Serious events: 115 serious events
Other events: 241 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clobazam
n=267 participants at risk
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
4/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Blood and lymphatic system disorders
Anaemia Macrocytic
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Cardiac disorders
Tachycardia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Congenital, familial and genetic disorders
Hip Dysplasia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Congenital, familial and genetic disorders
Talipes
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Endocrine disorders
Hypothalamo-Pituitary Disorder
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Eye disorders
Eye Disorder
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Constipation
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Dysphagia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Gastritis
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Haematemesis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Ileus
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Pancreatic Pseudocyst
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Stomatitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Volvulus
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
5/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Death
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Drug Interaction
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Oedema Peripheral
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Pitting Oedema
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Pneumatosis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Pyrexia
|
1.9%
5/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Bronchopneumonia
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Cellulitis
|
1.5%
4/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Chest Wall Abscess
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Cystitis Klebsiella
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Dengue Fever
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Ear Infection
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Febrile Infection
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Fungaemia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
4/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Gastroenteritis Viral
|
1.1%
3/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Implant Site Infection
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Incision Site Infection
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Influenza
|
1.5%
4/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Lobar Pneumonia
|
1.9%
5/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Lung Infection Pseudomonal
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Oesophageal Candidiasis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Oral Candidiasis
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Otitis Media
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Periorbital Cellulitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Pneumonia
|
9.7%
26/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Pneumonia Influenzal
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Pneumonia Mycoplasmal
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Pneumonia Viral
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchiolitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
1.1%
3/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Sepsis
|
1.9%
5/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Septic Shock
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Sinusitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Staphylococcal Infection
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Tooth Abscess
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Tracheitis
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Urinary Tract Infection
|
3.0%
8/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Urinary Tract Infection Fungal
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Varicella
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Viral Infection
|
1.1%
3/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Viral Tracheitis
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Bloody Airway Discharge
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Device Malfunction
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Fall
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Feeding Tube Complication
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.1%
3/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Foreign Body Trauma
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Jaw Fracture
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Shunt Malfunction
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Therapeutic Agent Toxicity
|
1.9%
5/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Ventriculoperitoneal Shunt Malfunction
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Investigations
Electroencephalogram
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Investigations
Hepatic Enzyme Increased
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Investigations
Oxygen Saturation Decreased
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
6/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Feeding Disorder
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Musculoskeletal and connective tissue disorders
Joint Contracture
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
1.9%
5/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Atonic Seizures
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Brain Injury
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Complex Partial Seizures
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Convulsion
|
11.2%
30/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Dystonia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Encephalopathy
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Epilepsy
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Grand Mal Convulsion
|
1.5%
4/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Hypertonia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Hypotonia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Intracranial Hypotension
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Lennox-Gastaut Syndrome
|
1.9%
5/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Lethargy
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Muscle Spasticity
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Myoclonic Epilepsy
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Petit Mal Epilepsy
|
1.1%
3/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Somnolence
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Status Epilepticus
|
4.1%
11/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Tremor
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Psychiatric disorders
Aggression
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Psychiatric disorders
Mental Status Changes
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Renal and urinary disorders
Trigonitis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Renal and urinary disorders
Urinary Retention
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
1.1%
3/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal Hypertrophy
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic Hernia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
5.6%
15/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
1.5%
4/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Hypertrophy
|
0.75%
2/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
1.1%
3/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Social circumstances
Activities Of Daily Living Impaired
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Surgical and medical procedures
Brain Operation
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Surgical and medical procedures
Medical Diet
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Surgical and medical procedures
Spinal Operation
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Surgical and medical procedures
Vagal Nerve Stimulator Implantation
|
1.5%
4/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Vascular disorders
Haematoma
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Vascular disorders
Hypotension
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.37%
1/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
Other adverse events
| Measure |
Clobazam
n=267 participants at risk
Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
13.1%
35/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
19/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
20/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Fatigue
|
6.7%
18/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
General disorders
Pyrexia
|
18.0%
48/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Ear Infection
|
5.6%
15/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Gastroenteritis
|
5.2%
14/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Influenza
|
6.4%
17/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Nasopharyngitis
|
11.6%
31/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Otitis Media
|
15.7%
42/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
6.7%
18/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Pneumonia
|
10.9%
29/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Sinusitis
|
12.0%
32/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
28.1%
75/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Urinary Tract Infection
|
13.1%
35/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Infections and infestations
Viral Infection
|
10.9%
29/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.9%
21/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Fall
|
16.5%
44/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
9.0%
24/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
5.2%
14/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Drooling
|
8.2%
22/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Lethargy
|
9.7%
26/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Sedation
|
7.9%
21/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Nervous system disorders
Somnolence
|
16.9%
45/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Psychiatric disorders
Aggression
|
8.2%
22/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Psychiatric disorders
Insomnia
|
11.6%
31/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.4%
17/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
15/267 • The protocol was written to go up to 60 months treatment however a percentage of patients went beyond 60 months until study completion when commercial product was made available.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review and approve all proposed abstracts, manuscripts, or presentations regarding this study prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER