Trial Outcomes & Findings for Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures (NCT NCT00594945)

NCT ID: NCT00594945

Last Updated: 2014-07-01

Results Overview

Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: Change from baseline to treatment day
• Results posted on: 2014-07-01

Participant Flow

Based on preliminary PK data, the study was terminated early prior to achieving planned enrollment numbers. Cohort 1 was dosed at 2mg. Cohort 2 was dosed at 3mg. Two subjects participated in both Cohorts.

Participant milestones

Measure	Intranasal Clonazepam 2 mg Treatment administered to subjects during Cohort 1	Intranasal Clonazepam 3 mg Treatment administered to subjects during Cohort 2	Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2
Cohort 1 / Treatment Period 1 STARTED	4	0	2
Cohort 1 / Treatment Period 1 COMPLETED	4	0	2
Cohort 1 / Treatment Period 1 NOT COMPLETED	0	0	0
Cohort 2 / Treatment Period 2 STARTED	0	3	2
Cohort 2 / Treatment Period 2 COMPLETED	0	3	2
Cohort 2 / Treatment Period 2 NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

Baseline characteristics by cohort

Measure	Intranasal Clonazepam 2 mg n=4 Participants	Intranasal Clonazepam 3 mg n=3 Participants	Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg n=2 Participants	Total n=9 Participants Total of all reporting groups
Age, Continuous	30.5 years STANDARD_DEVIATION 8.74 • n=5 Participants	29.7 years STANDARD_DEVIATION 7.37 • n=7 Participants	45.0 years STANDARD_DEVIATION 1.41 • n=5 Participants	33.4 years STANDARD_DEVIATION 9.25 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants
Region of Enrollment Finland	2 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline to treatment day

Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.

Outcome measures

Measure	Intranasal Clonazepam 2 mg n=6 Participants	Intranasal Clonazepam 3 mg n=5 Participants
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).	-7.4 percentage of baseline Standard Deviation 35.12	-26.1 percentage of baseline Standard Deviation 33.94

Adverse Events

Intranasal Clonazepam 2 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Intranasal Clonazepam 3 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intranasal Clonazepam 2 mg n=6 participants at risk	Intranasal Clonazepam 3 mg n=5 participants at risk
Eye disorders Lacrimation increased	33.3% 2/6	0.00% 0/5
Gastrointestinal disorders Abdominal Pain Upper	16.7% 1/6	0.00% 0/5
Gastrointestinal disorders Flatulence	16.7% 1/6	0.00% 0/5
Gastrointestinal disorders Tongue Ulceration	16.7% 1/6	0.00% 0/5
General disorders Fatigue	33.3% 2/6	40.0% 2/5
General disorders Thirst	16.7% 1/6	0.00% 0/5
Nervous system disorders Convulsion	16.7% 1/6	0.00% 0/5
Nervous system disorders Drooling	16.7% 1/6	0.00% 0/5
Nervous system disorders Dysgeusia	16.7% 1/6	0.00% 0/5
Nervous system disorders Parosmia	16.7% 1/6	0.00% 0/5
Nervous system disorders Somnolence	33.3% 2/6	0.00% 0/5
Nervous system disorders Tremor	16.7% 1/6	0.00% 0/5
Respiratory, thoracic and mediastinal disorders Nasal Discomfort	50.0% 3/6	0.00% 0/5
Respiratory, thoracic and mediastinal disorders Nasal Dryness	16.7% 1/6	0.00% 0/5
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 1/6	0.00% 0/5
Skin and subcutaneous tissue disorders Hypoaesthesia Facial	0.00% 0/6	20.0% 1/5
Skin and subcutaneous tissue disorders Petechiae	16.7% 1/6	0.00% 0/5
Vascular disorders Orthostatic Hypotension	16.7% 1/6	0.00% 0/5
Vascular disorders Pallor	16.7% 1/6	0.00% 0/5

Additional Information

Executive Director, Clinical Development

Jazz Pharmaceuticals, Inc.

Phone: 650 496 3777

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER