Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
Study Details
Study Description
Brief Summary
This Phase 3, multicenter, open-label study of chronic, intermittent use of study drug (DBF) is designed to evaluate the safety and tolerability of the buccal formulation of diazepam in children, adolescents and adults with intermittent, stereotypic episodes of frequent seizure activity (eg, seizure clusters) that are distinct from the subject's usual seizure pattern.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
The Primary objective of the study is to assess the safety and tolerability of DBF (study drug) administered a minimum of 3 times to subjects with epilepsy for the treatment of seizures over a minimum 6-month period.
Secondary objectives:
-
To evaluate the usability of study drug as assessed by the ability of caregivers/subjects to administer study drug based on the Instructions for Use (IFU).
-
To evaluate the Quality of Life (QoL) of the subjects during the study drug treatment period as assessed by use of age-appropriate epilepsy scales over a minimum 6-month period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subjects with Epilepsy Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening. |
Drug: Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category
The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) [Adverse events (AEs) were recorded from Day 1 through the last study contact (Month 7 telephone contact).]
A TEAE was defined as any adverse event with onset date on the day of or after administration of study drug including relationship and severity.
- Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) [AESIs were recorded from Day 1 through the last study contact (Month 7 telephone contact).]
A.Oral irritation related AEs including but not limited to: buccal mucosal swelling, mouth ulceration, injuries to oral cavity (such as tongue or mucosal laceration, broken tooth, bleeding), erythema, stomatitis, gingivitis, xerostomia, staining, dysphagia, dysgeusia, burning, stinging, tingling. B. Abuse related AEs including euphoria, euphoric mood, feeling of relaxation, anger, dissociative effects, hallucinations, psychosis, changes in mood, impaired cognition, attention, psychomotor effects, inappropriate affect, overdose, and misuse. C. Other: Respiratory disorders, nervous system disorders
Secondary Outcome Measures
- Usability Assessment: Number of Use Occasions Where Difficulty in Opening the Outer Packaging Was Recorded. [Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months]
For each use occasion the following question was asked: Did you have difficulty in opening the outer plastic packaging on this use occasion? Yes
- Usability Assessment: Ability to Open Foil Pouch on Each Use Occasion [Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months]
For each use occasion the following question was asked: Did you have difficulty in opening the foil pouch on this use occasion? Yes or No
- Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use Occasion [Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months]
For each use occasion the following question was asked: Did you have difficulty in removing study drug from foil pouch on this occasion? Yes or No
- Number of Occasions With Successful Insertion/Retention in Cheek [Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months]
Of the total number of use occasions over the course of the study, the number of use occasions that were successfully inserted/retained in the cheek
- Usability Assessment: Difficulty Inserting DBF Against the Buccal Mucosa (Number of Attempts to Insert Film for Each Use Occasion) [Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months]
Number of occasions where it took 1 attempt to insert film, Number of occasions where it took 2 attempts to insert film, Number of occasions where it took 3 attempts to insert film, Number of occasions where it took >3 attempts to insert film
- Usability Assessment: Number of Occasions Where DBF Was Not Placed or Retained on the Inner Cheek Until Dissolution [Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months]
Number of occasions where the study drug was not successfully placed and or retained in cheek until the film fully dissolved.
- Usability Assessment: Reasons for Multiple Placement/Insertion Attempts During a Use Occasion [Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months]
Reasons for multiple attempts at insertion Multiple choice answer was: Excessive drooling, Clenching jaw / Won't open mouth, Spit out before sticking, Other/None of the above
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female or male subject between the ages of 2 and 65 years of age, inclusive
-
Written informed consent to participate in the study
-
Subject has an established diagnosis of epilepsy either partial or generalized epilepsy with motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experiences bouts of seizures (frequent break through seizures, e.g. Acute Repetitive Seizures (ARS) or seizure clusters) and who, in the opinion of the Investigator, may need benzodiazepine intervention for seizure control at least 1 time a month on average.
-
Caregiver, if needed for subject, provides written informed consent and is able to administer study drug in the event of a seizure.
-
Female subjects ≥12 years of age have a negative serum pregnancy test at screening. Female subjects of childbearing potential, (not surgically sterile or less than 2 years postmenopausal), must have a partner who is sterile, agrees to abstinence, be practicing double barrier contraception or using an FDA approved contraceptive (e.g., licensed hormonal or barrier methods) for greater than 2 months prior to screening visit and commit to an acceptable form of birth control for the duration of the study and for 30 days after the study
-
No aspects of the medical history and/or the physical-neurological examination that at the judgment of the Investigator, in consultation with the Sponsor, will interfere with administration or absorption of study drug, or could evolve into a safety issue
-
No clinically significant abnormal findings on the electrocardiogram (QTcF≤450 msec for males and QTcF≤470 msec for females)
-
Subject and caregiver must be willing to comply with all study visits and all required study procedures
Exclusion Criteria:
-
A history of clinically significant gastrointestinal, renal/genitourinary, hepatic, hematologic, dermatologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other clinically significant abnormalities, such as physical examination, vital signs, laboratory tests or ECG at Screening or Baseline which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety or other medical conditions (e.g., cardiac, respiratory, gastrointestinal, psychiatric, renal disease) which are not adequately and stably controlled, or which in the opinion of the investigator(s) could affect the subject's safety or interfere with the study assessments or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject
-
Subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening
-
Subject with an active major depression or a past suicide attempt, or any suicidal ideation of 4, or 5 or any suicidal behavior in lifetime using Columbia-Suicide Severity Rating Scale(C-SSRS). The pediatric C-SSRS should be used for subjects 6 to 11 years of age. The adult C-SSRS should be used for subjects ≥12 years of age. Note that this exclusion is only applicable to cognitive-appropriate subjects who are able to understand and complete the Suicide Rating Scale
-
A history of allergic or adverse responses to diazepam or any other benzodiazepine
-
Participation in a clinical trial other than MonoSol Rx Phase 2 studies 160325 and 160326 within 30 days prior to Day 0. Participation in an observational (non-interventional) study is not an exclusion, provided that there are no scheduling conflicts with this study. Received any other investigational medication (unless it can be documented that the subject received only placebo) or device within 8 weeks or 5 half-lives (whichever is longer) before assignment to study drug treatment
-
Lactating female or positive serum pregnancy test (ß-hCG) at screening for female subjects ≥12 years of age
-
Positive blood screen for HIV, HbSAg, or Hepatitis C, or a positive urine screen for alcohol or drugs of abuse, except marijuana use for medicinal indications. When marijuana is or was used for medicinal indications in the opinion of the Investigator, it is not considered as drug abuse and the subject can be enrolled in states where medical marijuana use is legal, even if the marijuana metabolites in the urine revealed as positive
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hawaii Neuroscience Center | Honolulu | Hawaii | United States | 96187 |
| 2 | Consultants in Epilepsy and Neurology, PLLC | Boise | Idaho | United States | 83702 |
| 3 | Clinical Research Center of New Jersey (CRCNJ) | Voorhees | New Jersey | United States | 08043 |
| 4 | OnSite Clinical Solutions LLC | Charlotte | North Carolina | United States | 28203 |
| 5 | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 6 | Austin Epilepsy Care Center | Austin | Texas | United States | 78758 |
Sponsors and Collaborators
- Aquestive Therapeutics
- Syneos Health
- Covance
Investigators
- Study Director: Gary Slatko, Aquestive Therapeutics
Study Documents (Full-Text)
More Information
Publications
None provided.- 42-1703
Study Results
Participant Flow
| Recruitment Details | 150 subjects with epilepsy passed screening but 1 was never enrolled |
|---|---|
| Pre-assignment Detail | 149 were enrolled but only 130 received at least 1 dose of study drug and were included in the analyses |
| Arm/Group Title | Safety Set |
|---|---|
| Arm/Group Description | Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening. Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff. |
| Period Title: Overall Study | |
| STARTED | 130 |
| COMPLETED | 90 |
| NOT COMPLETED | 40 |
Baseline Characteristics
| Arm/Group Title | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| Arm/Group Description | Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening. Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff. |
| Overall Participants | 130 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
25.9
(13.28)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
66
50.8%
|
| Male |
64
49.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
29
22.3%
|
| Not Hispanic or Latino |
99
76.2%
|
| Unknown or Not Reported |
2
1.5%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
5
3.8%
|
| Native Hawaiian or Other Pacific Islander |
6
4.6%
|
| Black or African American |
12
9.2%
|
| White |
99
76.2%
|
| More than one race |
8
6.2%
|
| Unknown or Not Reported |
0
0%
|
| Body Mass Index (kg/m^2 (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
24.108
(6.8148)
|
Outcome Measures
| Title | Number of Subjects in the Safety Analysis Set With at Least 1 Treatment-emergent Adverse Event (TEAE) |
|---|---|
| Description | A TEAE was defined as any adverse event with onset date on the day of or after administration of study drug including relationship and severity. |
| Time Frame | Adverse events (AEs) were recorded from Day 1 through the last study contact (Month 7 telephone contact). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug |
| Arm/Group Title | Safety Analysis Set: Enrolled Subjects With Epilepsy Who Received at Least 1 Dose of Study Drug |
|---|---|
| Arm/Group Description | Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening. Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff. |
| Measure Participants | 130 |
| At least 1 TEAE |
84
64.6%
|
| At least 1 severe TEAE |
14
10.8%
|
| At least 1 study drug related TEAE |
10
7.7%
|
| At least 1 severe and related TEAE |
1
0.8%
|
| At least 1 serious TEAE |
18
13.8%
|
| At least 1 serious and related TEAE |
1
0.8%
|
| Title | Number of Subjects in Safety Analysis Set With Adverse Events of Special Interest (AESI) |
|---|---|
| Description | A.Oral irritation related AEs including but not limited to: buccal mucosal swelling, mouth ulceration, injuries to oral cavity (such as tongue or mucosal laceration, broken tooth, bleeding), erythema, stomatitis, gingivitis, xerostomia, staining, dysphagia, dysgeusia, burning, stinging, tingling. B. Abuse related AEs including euphoria, euphoric mood, feeling of relaxation, anger, dissociative effects, hallucinations, psychosis, changes in mood, impaired cognition, attention, psychomotor effects, inappropriate affect, overdose, and misuse. C. Other: Respiratory disorders, nervous system disorders |
| Time Frame | AESIs were recorded from Day 1 through the last study contact (Month 7 telephone contact). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug |
| Arm/Group Title | Subjects With Epilepsy |
|---|---|
| Arm/Group Description | Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening. Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff. |
| Measure Participants | 130 |
| Any adverse event of special interest |
32
24.6%
|
| Any oral irritation adverse event |
3
2.3%
|
| Any oral safety adverse event |
8
6.2%
|
| Any potential abuse related adverse event |
21
16.2%
|
| Any abuse related adverse event |
1
0.8%
|
| Any other adverse event of special interest |
8
6.2%
|
| Title | Usability Assessment: Number of Use Occasions Where Difficulty in Opening the Outer Packaging Was Recorded. |
|---|---|
| Description | For each use occasion the following question was asked: Did you have difficulty in opening the outer plastic packaging on this use occasion? Yes |
| Time Frame | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug (Safety Analysis Set) |
| Arm/Group Title | Total Use Occasions |
|---|---|
| Arm/Group Description | Analysis is based upon the total number times the study drug was used over the course of the study - subjects could have multiple use occasions during the study: Total number of use occasions reported was 1348 for the total 130 subjects in the Safety Population |
| Measure Participants | 130 |
| Measure total number of use occasions | 1348 |
| Number [total number of use occasions] |
211
|
| Title | Usability Assessment: Ability to Open Foil Pouch on Each Use Occasion |
|---|---|
| Description | For each use occasion the following question was asked: Did you have difficulty in opening the foil pouch on this use occasion? Yes or No |
| Time Frame | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Number of subjects reporting use occasions |
| Arm/Group Title | Study Drug Use Occasions |
|---|---|
| Arm/Group Description | Total number of use occasions reported over the course of the study; each subject could report multiple use occasions during the study |
| Measure Participants | 130 |
| Measure total number of use occasions | 1348 |
| Yes, I had difficulty opening the foil pouch |
391
|
| No, I did not have difficulty opening the foil pouch |
957
|
| Title | Usability Assessment: Ability to Remove Study Drug From Foil Pouch on Each Use Occasion |
|---|---|
| Description | For each use occasion the following question was asked: Did you have difficulty in removing study drug from foil pouch on this occasion? Yes or No |
| Time Frame | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug (Safety Analysis Set) |
| Arm/Group Title | Study Drug Use Occasions |
|---|---|
| Arm/Group Description | Total number of use occasions reported during the study; each subject could report multiple use occasions over the course of the study |
| Measure Participants | 130 |
| Measure total number of use occasions rpoeted | 1348 |
| Yes, I had difficulty removing study drug from pouch on this occasion |
47
|
| No, I did not have difficulty removing study drug from the pouch on this occasion |
1301
|
| Title | Number of Occasions With Successful Insertion/Retention in Cheek |
|---|---|
| Description | Of the total number of use occasions over the course of the study, the number of use occasions that were successfully inserted/retained in the cheek |
| Time Frame | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug (Safety Analysis Set) |
| Arm/Group Title | Study Drug Use Occasions |
|---|---|
| Arm/Group Description | Total number of use occasions reported during the study; each subject could report multiple use occasions over the course of the study |
| Measure Participants | 130 |
| Measure total number of use occasions | 1348 |
| Number [Number of events] |
1330
|
| Title | Usability Assessment: Difficulty Inserting DBF Against the Buccal Mucosa (Number of Attempts to Insert Film for Each Use Occasion) |
|---|---|
| Description | Number of occasions where it took 1 attempt to insert film, Number of occasions where it took 2 attempts to insert film, Number of occasions where it took 3 attempts to insert film, Number of occasions where it took >3 attempts to insert film |
| Time Frame | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug (Safety Analysis Set) |
| Arm/Group Title | Study Drug Use Occasions |
|---|---|
| Arm/Group Description | Total number of use occasions reported during the study; each subject could report multiple use occasions over the course of the study |
| Measure Participants | 130 |
| Measure total number of use occasions | 1348 |
| Number of occasions where it required 1 attempt to insert film |
1268
|
| Number of occasions that required 2 attempts to insert film |
38
|
| Number of occasions that required 3 attempts to insert film |
18
|
| Number of occasions that required >3 attempts to insert film |
6
|
| Title | Usability Assessment: Number of Occasions Where DBF Was Not Placed or Retained on the Inner Cheek Until Dissolution |
|---|---|
| Description | Number of occasions where the study drug was not successfully placed and or retained in cheek until the film fully dissolved. |
| Time Frame | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug (Safety Analysis Set) |
| Arm/Group Title | Study Drug Use Occasions |
|---|---|
| Arm/Group Description | Total number of use occasions reported over the course of the study; each subject could report multiple use occasions during the study |
| Measure Participants | 130 |
| Measure total number of use occasions | 1348 |
| Count of Units [total number of use occasions] |
16
|
| Title | Usability Assessment: Reasons for Multiple Placement/Insertion Attempts During a Use Occasion |
|---|---|
| Description | Reasons for multiple attempts at insertion Multiple choice answer was: Excessive drooling, Clenching jaw / Won't open mouth, Spit out before sticking, Other/None of the above |
| Time Frame | Recorded in an electronic diary after each use of study drug, throughout the course of the study; approximately 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who received at least 1 dose of study drug (Safety Analysis Set) |
| Arm/Group Title | Study Drug Use Occasions |
|---|---|
| Arm/Group Description | Total number of use occasions reported during the study; each subject could report multiple use occasions over the course of the study |
| Measure Participants | 130 |
| Measure total number of use occasions | 1348 |
| Clenching jaw / won't open mouth |
21
|
| Excessive drooling |
24
|
| Spit out before sticking |
17
|
| Other (none of the above) |
33
|
Adverse Events
| Time Frame | Adverse events that started after the first intake of DBF through the Final Visit were considered treatment-emergent adverse events (TEAEs). | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Safety Analysis Set | |
| Arm/Group Description | Male or female subjects between the ages of 2 and 65 years who had an established diagnosis of epilepsy exhibited by motor seizures with clear alteration of awareness, and while on a regimen of anti-epileptic medication(s), still experienced bouts of seizures (frequent breakthrough seizures, eg, seizure clusters) and who, in the opinion of the Investigator, could need benzodiazepine intervention for seizure control at least 1 time a month on average. Subjects must have been on at least 1 concomitant anti-epileptic drug at screening. Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category: The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff. | |
All Cause Mortality |
||
| Safety Analysis Set | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/130 (2.3%) | |
Serious Adverse Events |
||
| Safety Analysis Set | ||
| Affected / at Risk (%) | # Events | |
| Total | 17/130 (13.1%) | |
| Gastrointestinal disorders | ||
| Enterocolitis | 1/130 (0.8%) | 1 |
| Nausea | 1/130 (0.8%) | 1 |
| Small bowel obstruction | 1/130 (0.8%) | 1 |
| Vomiting | 1/130 (0.8%) | 1 |
| General disorders | ||
| Death | 1/130 (0.8%) | 1 |
| Infections and infestations | ||
| Pneumonia | 1/130 (0.8%) | 1 |
| Injury, poisoning and procedural complications | ||
| Joint dislocation | 1/130 (0.8%) | 1 |
| Toxicity to various agents | 1/130 (0.8%) | 1 |
| Metabolism and nutrition disorders | ||
| Hypokalaemia | 1/130 (0.8%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Brain neoplasm malignant | 1/130 (0.8%) | 1 |
| Nervous system disorders | ||
| Seizure | 1/130 (0.8%) | 1 |
| Epilepsy | 1/130 (0.8%) | 1 |
| Partial seizure | 1/130 (0.8%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Aspiration | 1/130 (0.8%) | 3 |
| Acute respiratory failure | 1/130 (0.8%) | 1 |
| Pneumonitis | 1/130 (0.8%) | 1 |
| Respiratory failure | 1/130 (0.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Safety Analysis Set | ||
| Affected / at Risk (%) | # Events | |
| Total | 84/130 (64.6%) | |
| Gastrointestinal disorders | ||
| Vomiting | 7/130 (5.4%) | 8 |
| Nausea | 5/130 (3.8%) | 5 |
| Diarrhoea | 4/130 (3.1%) | 6 |
| General disorders | ||
| Pyrexia | 7/130 (5.4%) | 12 |
| Infections and infestations | ||
| Upper respiratory tract infection | 8/130 (6.2%) | 8 |
| Sinusitis | 6/130 (4.6%) | 6 |
| Ear infection | 4/130 (3.1%) | 4 |
| Injury, poisoning and procedural complications | ||
| Fall | 5/130 (3.8%) | 7 |
| Skin abrasion | 4/130 (3.1%) | 5 |
| Investigations | ||
| Weight decreased | 4/130 (3.1%) | 6 |
| Weight increased | 4/130 (3.1%) | 6 |
| Nervous system disorders | ||
| Seizure | 26/130 (20%) | 98 |
| Somnolence | 6/130 (4.6%) | 6 |
| Lethargy | 4/130 (3.1%) | 5 |
| Dizziness | 4/130 (3.1%) | 4 |
| Headache | 4/130 (3.1%) | 4 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 5/130 (3.8%) | 6 |
| Pneumonia aspiration | 4/130 (3.1%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Clinical Project Manager |
|---|---|
| Organization | Aquestive Therapeutics |
| Phone | 9089411896 |
| cbuan@aquestive.com |
- 42-1703