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Trial record 71 of 146 for:    epilepsy AND Bethesda

Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00594945
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Clonazepam
Enrollment 45
Recruitment Details  
Pre-assignment Details

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.

Arm/Group Title Intranasal Clonazepam 2 mg Intranasal Clonazepam 3 mg Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg
Hide Arm/Group Description Treatment administered to subjects during Cohort 1 Treatment administered to subjects during Cohort 2 Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2
Period Title: Cohort 1 / Treatment Period 1
Started 4 0 2
Completed 4 0 2
Not Completed 0 0 0
Period Title: Cohort 2 / Treatment Period 2
Started 0 3 2
Completed 0 3 2
Not Completed 0 0 0
Arm/Group Title Intranasal Clonazepam 2 mg Intranasal Clonazepam 3 mg Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 4 3 2 9
Hide Baseline Analysis Population Description
There were 9 subjects total and 2 subjects were enrolled in both Cohorts.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 2 participants 9 participants
30.5  (8.74) 29.7  (7.37) 45.0  (1.41) 33.4  (9.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 2 participants 9 participants
Female
2
  50.0%
0
   0.0%
0
   0.0%
2
  22.2%
Male
2
  50.0%
3
 100.0%
2
 100.0%
7
  77.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 2 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
3
 100.0%
2
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 2 participants 9 participants
United States 2 1 1 4
Finland 2 2 1 5
1.Primary Outcome
Title Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
Hide Description Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.
Time Frame Change from baseline to treatment day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intranasal Clonazepam 2 mg Intranasal Clonazepam 3 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: percentage of baseline
-7.4  (35.12) -26.1  (33.94)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intranasal Clonazepam 2 mg Intranasal Clonazepam 3 mg
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Intranasal Clonazepam 2 mg Intranasal Clonazepam 3 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intranasal Clonazepam 2 mg Intranasal Clonazepam 3 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intranasal Clonazepam 2 mg Intranasal Clonazepam 3 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   2/5 (40.00%) 
Eye disorders     
Lacrimation increased * 1  2/6 (33.33%)  0/5 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain Upper * 1  1/6 (16.67%)  0/5 (0.00%) 
Flatulence * 1  1/6 (16.67%)  0/5 (0.00%) 
Tongue Ulceration * 1  1/6 (16.67%)  0/5 (0.00%) 
General disorders     
Fatigue * 1  2/6 (33.33%)  2/5 (40.00%) 
Thirst * 1  1/6 (16.67%)  0/5 (0.00%) 
Nervous system disorders     
Convulsion * 1  1/6 (16.67%)  0/5 (0.00%) 
Drooling * 1  1/6 (16.67%)  0/5 (0.00%) 
Dysgeusia * 1  1/6 (16.67%)  0/5 (0.00%) 
Parosmia * 1  1/6 (16.67%)  0/5 (0.00%) 
Somnolence * 1  2/6 (33.33%)  0/5 (0.00%) 
Tremor * 1  1/6 (16.67%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal Discomfort * 1  3/6 (50.00%)  0/5 (0.00%) 
Nasal Dryness * 1  1/6 (16.67%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis * 1  1/6 (16.67%)  0/5 (0.00%) 
Hypoaesthesia Facial * 1  0/6 (0.00%)  1/5 (20.00%) 
Petechiae * 1  1/6 (16.67%)  0/5 (0.00%) 
Vascular disorders     
Orthostatic Hypotension * 1  1/6 (16.67%)  0/5 (0.00%) 
Pallor * 1  1/6 (16.67%)  0/5 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Director, Clinical Development
Organization: Jazz Pharmaceuticals, Inc.
Phone: 650 496 3777
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00594945     History of Changes
Other Study ID Numbers: 07-001
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: June 26, 2013
Results First Posted: July 1, 2014
Last Update Posted: July 1, 2014