Trial Outcomes & Findings for Clobazam in Subjects With Lennox-Gastaut Syndrome (NCT NCT00162981)

Last Updated: 2012-02-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

4-week baseline period and 4-week maintenance period

Results posted on

2012-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Clobazam Low Dose 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose 5 to 40 mg/day with doses in the morning and at bedtime; orally
Overall Study STARTED	32	36
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Clobazam Low Dose 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose 5 to 40 mg/day with doses in the morning and at bedtime; orally
Overall Study Adverse Event	2	5
Overall Study Withdrawal by Subject	1	1
Overall Study Physician Decision	1	0

Baseline Characteristics

Clobazam in Subjects With Lennox-Gastaut Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clobazam Low Dose n=32 Participants 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=36 Participants 5 to 40 mg/day with doses in the morning and at bedtime; orally	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	9.18 years STANDARD_DEVIATION 5.37 • n=5 Participants	8.51 years STANDARD_DEVIATION 5.14 • n=7 Participants	8.82 years STANDARD_DEVIATION 5.22 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4-week baseline period and 4-week maintenance period

Population: Modified Intention-to-Treat (MITT) populations consist of all randomized patients who received study medication and who have both a baseline and post-baseline measurement and have at least one measurement during the maintenance period.

Outcome measures

Outcome measures
Measure	Clobazam Low Dose n=29 Participants 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=32 Participants 5 to 40 mg/day with doses in the morning and at bedtime; orally
Percent Reduction in Number of Drop Seizures.	10.1 Percent Reduction Standard Deviation 122.3	85.2 Percent Reduction Standard Deviation 17.1

PRIMARY outcome

Timeframe: 4-week baseline period and the 4-week maintenance period

Population: MITT population

Outcome measures

Outcome measures
Measure	Clobazam Low Dose n=29 Participants 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=32 Participants 5 to 40 mg/day with doses in the morning and at bedtime; orally
A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.	29 Percent Reduction Interval -531.0 to 100.0	93 Percent Reduction Interval 48.0 to 100.0

SECONDARY outcome

Timeframe: 4-week baseline period and 4-week maintenance period

Outcome measures

Outcome measures
Measure	Clobazam Low Dose n=32 Participants 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=36 Participants 5 to 40 mg/day with doses in the morning and at bedtime; orally
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. ≥ 25% reduction	18 Percent of participants	32 Percent of participants
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. ≥ 50% reduction	12 Percent of participants	30 Percent of participants
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. ≥ 75% reduction	7 Percent of participants	23 Percent of participants
Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures. 100% reduction	2 Percent of participants	8 Percent of participants

SECONDARY outcome

Timeframe: Week 3

Population: MITT population, baseline evaluations compared to Week 3 evaluations.

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".

Outcome measures

Outcome measures
Measure	Clobazam Low Dose n=32 Participants 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=36 Participants 5 to 40 mg/day with doses in the morning and at bedtime; orally
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Very Much Improved	7 participants	15 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Much Improved	9 participants	15 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Minimally Improved	9 participants	1 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. No Change	3 participants	0 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Minimally Worse	0 participants	1 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Much Worse	1 participants	0 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Very Much Worse	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 7

Population: MITT population, baseline evaluations compared to Week 7 evaluations.

Outcome measures

Outcome measures
Measure	Clobazam Low Dose n=32 Participants 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=36 Participants 5 to 40 mg/day with doses in the morning and at bedtime; orally
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Very Much Improved	6 participants	16 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Much Improved	6 participants	11 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Minimally Improved	10 participants	1 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. No Change	5 participants	0 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Minimally Worse	1 participants	1 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Much Worse	0 participants	0 participants
Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms. Very Much Worse	0 participants	0 participants

Adverse Events

Clobazam Low Dose

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Clobazam High Dose

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clobazam Low Dose n=32 participants at risk 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=36 participants at risk 5 to 40 mg/day with doses in the morning and at bedtime; orally
Gastrointestinal disorders Constipation	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	2.8% 1/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
General disorders Pyrexia	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	2.8% 1/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	2.8% 1/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Respiratory, thoracic and mediastinal disorders Sleep Apnea Syndrome	3.1% 1/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	0.00% 0/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	2.8% 1/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.

Other adverse events

Additional Information

Email contact via H. Lundbeck A/S

Lundbeck LLC

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal Investigator agrees to delete, at Sponsor's request, from any proposed Public Presentation any information or material that Sponsor deems confidential or proprietary.
Publication restrictions are in place

Restriction type: OTHER

Measure	Clobazam Low Dose n=32 participants at risk 5 to 10 mg/day with doses in the morning and at bedtime; orally	Clobazam High Dose n=36 participants at risk 5 to 40 mg/day with doses in the morning and at bedtime; orally
Psychiatric disorders Abnormal Behavior	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Psychiatric disorders Aggression	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	8.3% 3/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Gastrointestinal disorders Constipation	3.1% 1/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	8.3% 3/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Injury, poisoning and procedural complications Contusion	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	0.00% 0/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Nervous system disorders Convulsion	9.4% 3/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	2.8% 1/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Nervous system disorders Coordination abnormal	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Gastroenteritis viral	9.4% 3/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	0.00% 0/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Psychiatric disorders Hypomania	3.1% 1/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	8.3% 3/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Psychiatric disorders Insomnia	3.1% 1/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	8.3% 3/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
General disorders Irritability	3.1% 1/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Nervous system disorders Lethargy	9.4% 3/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	11.1% 4/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Nasopharyngitis	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	11.1% 4/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Otitis media	12.5% 4/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	0.00% 0/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Pneumonia	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
General disorders Pyrexia	3.1% 1/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Gastrointestinal disorders Salivary hypersecretion	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	8.3% 3/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Nervous system disorders Sedation	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	8.3% 3/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Sinusitis	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Injury, poisoning and procedural complications Skin laceration	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Nervous system disorders Somnolence	12.5% 4/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	19.4% 7/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Gastrointestinal disorders Toothache	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	0.00% 0/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Upper respiratory tract infection	9.4% 3/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	2.8% 1/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Viral infection	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	11.1% 4/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Infections and infestations Viral upper respiratory tract infection	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	2.8% 1/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Gastrointestinal disorders Vomiting	0.00% 0/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	5.6% 2/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.
Psychiatric disorders Affect lability	6.2% 2/32 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.	0.00% 0/36 • Up to 15 weeks Adverse Events were assessed by the Investigator at the end of the 4 week Baseline period (Day -1) and at weekly/biweekly visits (Weeks 1, 2, 3, 5, 7, 9 and 11) throughout the study.