EpilepsyPhase 1/2NCT03953820
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
A Phase 1/2 study testing Diazepam Buccal Film and Diastat® Rectal Gel (Valeant Pharmaceuticals USA) in people with Epilepsy, run by Aquestive Therapeutics at 3 sites in United States.
Trial summary
This was a multiple centers, single-dose, open-label, randomized two-sequence crossover, two-period study to evaluate the pharmacokinetics (PK) of single doses of Diazepam Buccal Film (DBF) compared with Diastat® Rectal Gel (DRG) under fed conditions in adult male and female participants on a stable concomitant… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Diazepam Buccal Film and Diastat® Rectal Gel (Valeant Pharmaceuticals USA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Apr 2019to 31 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, smoker (no more than 25 cigarettes or equivalent daily) or non-smoker, ≥ 18 and ≤ 65 years of age, with body weight between 38 and 111 kg, inclusive. Potential subjects with weights in the range of 112 to 134 kg (247 - 249 pounds) may be allowed to participate in the study at the discretion of the Principal Investigator.
- On a stable and ongoing regimen of at least one AED for treatment of epilepsy. Stable regimen is defined as no change in AED regimen for at least 30 days before the first study drug administration and no change anticipated in the prescribed AED regimen over the course of study participation.
- Subjects must have a diagnosis of seizure disorder (any seizure type or frequency) under treatment with at least one AED.
- Healthy (except for seizure disorder), according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Principal Investigator/Sub- Investigator.
- Clinical laboratory values within local laboratories acceptable ranges, unless values are deemed by the Principal Investigator/Sub-Investigator as "Not Clinically Significant".
- Ability to comprehend and be informed of the nature of the study, as assessed by clinic staff.
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- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
- Agree not to have a tattoo or tongue or body piercing until the end of the study.
- Agree not to drive or operate heavy machinery if feeling dizzy or drowsy following drug administration until full mental alertness is regained.
- Subjects must be able and willing to remove denture or bracing at the time of dosing.
- Non-vasectomized male subjects must use two forms of medically accepted method of contraception with all sexual partners of childbearing potential during the study and for 111 days following the last dose of study drug. Medically accepted effective forms of contraception include:
- simultaneous use of a male condom and
- for the female partner, hormonal contraceptives (used since at least 4 weeks) or intrauterine contraceptive device (placed since at least 4 weeks) or diaphragm or cervical cap with intravaginally applied spermicide.
- Male subjects must be willing not to donate sperm until 111 days following the last study drug administration.
- Female subjects who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized since at least 6 months) must fulfill at least one of the following:
- Be surgically sterile for a minimum of 6 months;
- Post-menopausal for a minimum of 1 year;
- Agree to avoid pregnancy and use medically acceptable method of contraception as described below until at least 51 days after the last PK blood sample collection of the study. Medically acceptable methods of contraception include:
- Intrauterine device (hormonal and non-hormonal) placed at least 4 weeks prior to first study drug administration,
- Oral or transdermal hormonal contraceptives with a 28-days treatment cycle taken daily from at least 30 days prior to first study drug administration and with no expected change in dosage throughout the study, or • Double barrier method (male condom and intravaginally applied spermicide used simultaneously with diaphragm or cervical cap) starting at least 21 days prior to first study drug administration;
- agree to complete abstinence.
Who cannot join
- Clinically significant abnormal laboratory test results found during medical screening.
- Positive pregnancy test at screening.
- Known presence of any clinically significant: hepatic (e.g. hepatic impairment), renal/genitourinary (renal impairment, kidney stones), gastrointestinal (e.g. ulcerative colitis, ileus, partial or complete intestinal blockage, appendicitis), cardiovascular (e.g. uncontrolled hypertension), cerebrovascular, pulmonary, endocrine (controlled diabetes is acceptable), immunological, musculoskeletal, neurological (other than known seizure disorder), psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator and confirmed by Sponsor via written communication prior to subject enrollment.
- Presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the study drug experienced within 7 days prior to first study drug administration, as determined by the Principal Investigator/Sub-Investigator.
- Any clinically significant rectal abnormality by history or physical examination, or any condition, for which, in the judgment of the Principal Investigator/Sub-Investigator, administration of rectal gel would cause a potential risk to the subject.
- Baseline levels of concomitant AED outside of the acceptable therapeutic range at screening.
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- Presence of any clinically significant illness within 30 days prior to first study drug administration, as determined by the Principal Investigator/Sub-Investigator.
- Presence of any clinically significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator.
- Presence of any clinically significant lesion of the oral cavity.
- Clinically significant ECG abnormalities (QTcF interval > 450 msec for males or QTcF interval > 470 msec for females) or vital sign abnormalities (systolic blood pressure lower than 90 or over 160 mmHg, diastolic blood pressure lower than 50 or over 100 mmHg, or heart rate less than 50 or over 100 bpm) at screening, unless deemed otherwise by the Principal Investigator/Sub-Investigator.
- A positive test result for HIV, Hepatitis B surface antigen, Hepatitis C.
- A positive test result for any of the following: drugs of abuse (amphetamines, methamphetamines, barbiturates, cocaine, opiates, phencyclidine, tetrahydrocannabinol,MDMA, methadone, and benzodiazepines, except where a positive test is consistent with a stable regimen of a prescribed medication) and alcohol breath test.
- Known history or presence of:
- Alcohol abuse or dependence within one year prior to screening;
- Drug abuse or dependence;
- Hypersensitivity or idiosyncratic reaction to diazepam, DBF excipients, DRG excipients;
- Glaucoma (open or acute narrow angle);
- Food allergies and/or presence of any dietary restrictions that, in the judgment of the investigator or the Sponsor, would interfere with study procedures or the subject's safe participation in the study.
- Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
- Intolerance to and/or difficulty with blood sampling through venipuncture.
- Individuals who have donated, in the days prior to first study drug administration:
- 50-499 mL of blood in the previous 30 days;
- 500 mL or more in the previous 56 days.
- Donation of plasma by plasmapheresis within 7 days prior to first study drug administration.
- Individuals who have participated in another clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study including an investigational study involving no drug or device administration.
- Use of diazepam within 30 days prior to first study drug administration.
- Use of strong inhibitors of CYP enzymes (e.g. cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) in the previous 30 days before first study drug administration. Use of strong inducers of CYP enzymes (e.g. barbiturates, carbamazepine, glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) and AEDs known to induce CYP enzymes are permitted provided that the regimen of such drugs is stable (taken at least q.d. on a regular basis) within 30 days prior to first study drug administration and until 10 days after last study drug administration.
- Use of any prescription medication (other than non-systemic topical products) within 30 days prior to first study drug administration. A prescription drug (other than diazepam and any benzodiazepines, phenothiazines, and strong inhibitors of CYP enzymes) that is part of a stable drug regimen (taken at least q.d. on a regular basis) is allowed if taken from at least 30 days prior to the first study drug administration and if there is no expected change in dosage throughout the study.
- Use of any OTC medications (other than spermicidal/barrier contraceptive products and nonsystemic topical products), within 30 days prior to first study drug administration. OTC drugs that is part of a stable drug regimen (taken at least q.d. on a regular basis) is allowed if taken from at least 30 days prior to the first study drug administration and if there is no expected change in dosage throughout the study.
- Natural health products (including oral multivitamins, herbal and/or dietary supplements and/or teas) from 30 days pre-dose until after the last PK blood sample collection of each period.
- Use of marijuana and THC containing products within 3 months prior to screening unless such products are a part of the subject's stable antiepileptic regimen.
- Use of any monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine), phenothiazines (e.g. chlorpromazine) within 30 days prior to first study drug administration.
- Female subjects who have taken oral or transdermal hormonal contraceptives (other than 28-days treatment cycle contraceptive products) within 30 days prior to first drug administration, or have used an implanted, injected, or intravaginal contraceptive within 6 months prior to first drug administration.
- Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by Principal Investigator/Sub-Investigator.
- Presence of mouth jewellery, dentures, braces, or piercings in the mouth or tongue that, in the opinion of the Principal Investigator, would be likely to interfere with successful completion of the dosing procedure
- Dental procedures performed within 14 days of dosing or dental procedures scheduled to occur during study duration.
- Unable or unwilling to provide informed consent.
- Have had a tattoo or body/mouth piercing within 30 days prior to first study drug administration.
- Employee or immediate relative of an employee of Aquestive Therapeutics, any of its affiliates or partners, of the CRO, or the clinical site.
- Breast-feeding subject.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Clinical Trials of Florida, LLC
Miami, Florida, 33186
Bioclinica Research
Orlando, Florida, 32806
Florida Premier Research Institute, LLC
Winter Park, Florida, 32789
About this study
Official title: Randomized, Open-Label, 2-Way Crossover, 3-Period Study to Evaluate Single Doses of Diazepam Buccal Film Compared With Diazepam Rectal Gel in Adult Males and Females on Concomitant Antiepileptic Drugs for the Treatment of Epilepsy
This was a multiple centers, single-dose, open-label, randomized two-sequence crossover, two-period study to evaluate the pharmacokinetics (PK) of single doses of Diazepam Buccal Film (DBF) compared with Diastat® Rectal Gel (DRG) under fed conditions in adult male and female participants on a stable concomitant regimen of anti-epileptic drugs for the treatment of epilepsy.
Read the detailed description
Period 1 was a randomized, 2-sequence, crossover study in which participants received DBF and DRG following a moderate-fat meal in a randomized sequence with a washout period of 28 days between doses. DBF dose was based on body weight according to the currently recommended dose regimen (derived by Aquestive from population PK modeling in healthy volunteers). DRG dose was based on body weight according to the current product labeling for DRG.
Period 2: Participants who completed Period 1 were asked to participate in a second period on a voluntary basis during which volunteers received a second dose of DBF administered at the same dose and in exactly the same manner as the earlier dose of DBF with the exception that DBF was administered following a high-fat meal.
- Conditions
- Epilepsy
- Being tested
- Diazepam Buccal Film, Diastat® Rectal Gel (Valeant Pharmaceuticals USA)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazepam Buccal FilmDrug
Also called DBF
Diazepam Buccal Film administered on inner aspect of the cheek at the recommended dose regimen (10 mg to 17.5 mg according to body weight) following ingestion of a moderate fat meal and following ingestion of a high-fat meal.
Diastat® Rectal Gel (Valeant Pharmaceuticals USA)Drug
Also called DRG
Diastat Rectal Gel administered rectally according to product label administration and dosing instructions (10 mg to 20 mg according to body weight) following ingestion of a moderate-fat meal.
| Study group | Role | What they receive |
|---|---|---|
| Diazepam Buccal Film, Then Diastat Rectal Gel | Experimental | Participants received a single dose of Diazepam Buccal Film following a moderate-fat meal and then received a single dose of Diastat Rectal Gel following a moderate-fat meal with a 28-day washout between doses. Receives: Drug: Diazepam Buccal Film; Drug: Diastat® Rectal Gel (Valeant Pharmaceuticals USA) |
| Diastat Rectal Gel, Then Diazepam Buccal Film | Experimental | Participants received a single dose of Diastat Rectal Gel following a moderate-fat meal and then received a single dose of Diazepam Buccal Film following a moderate-fat meal with a 28-day washout between doses. Receives: Drug: Diazepam Buccal Film; Drug: Diastat® Rectal Gel (Valeant Pharmaceuticals USA) |
| Diazepam Buccal Film following a High-Fat Meal | Experimental | Participants who volunteered to participate in the second period received a second dose of Diazepam Buccal Film at the same dose and exactly the same manner as the earlier dose with the exception that the dose was administered following ingestion of a high-fat meal. Receives: Drug: Diazepam Buccal Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-t
Area Under Plasma Concentration-Time Curve From Time Zero to the last non-zero concentration
Measured: 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
AUC 0-inf
Area under concentration time curve, from time 0 extrapolated to infinity
Measured: 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Cmax
Maximum observed plasma concentration
Measured: 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start13 Apr 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study consisted of 2 periods. In Period 1 , participants received a single dose of Diazepam Buccal Film or Diastat Rectal Gel in a randomized sequence following a moderate fat meal with a 28-day washout between doses. Subjects who completed Period 1 were asked to participate in a second period (Period 2) on a voluntary basis. Those subjects who agreed to participate in Period 2 received a second dose of DBF in exactly the same dose and manner as the earlier dose with the exception it was administered following a high fat meal.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquestive Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Slatko, MD, Study chair, Aquestive Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953820
- Sponsor's protocol ID
- 180323
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2019
- Last updated
- 18 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, 2-Way Crossover, 3-Period Study to Evaluate Single Doses of Diazepam Buccal Film Compared With Diazepam Rectal Gel in Adult Males and Females on Concomitant Antiepileptic Drugs for the Treatment of Epilepsy
- ClinicalTrials.gov ID
- NCT03953820
- Acronym / sponsor ID
- 180323
- Conditions
- Epilepsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Aquestive TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multiple centers, single-dose, open-label, randomized two-sequence crossover, two-period study to evaluate the pharmacokinetics (PK) of single doses of Diazepam Buccal Film (DBF) compared with Diastat® Rectal Gel (DRG) under fed conditions in adult male and female participants on a stable concomitant regimen of anti-epileptic drugs for the treatment of epilepsy.
Detailed description
Period 1 was a randomized, 2-sequence, crossover study in which participants received DBF and DRG following a moderate-fat meal in a randomized sequence with a washout period of 28 days between doses. DBF dose was based on body weight according to the currently recommended dose regimen (derived by Aquestive from population PK modeling in healthy volunteers). DRG dose was based on body weight according to the current product labeling for DRG.
Period 2: Participants who completed Period 1 were asked to participate in a second period on a voluntary basis during which volunteers received a second dose of DBF administered at the same dose and in exactly the same manner as the earlier dose of DBF with the exception that DBF was administered following a high-fat meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study consisted of 2 periods. In Period 1 , participants received a single dose of Diazepam Buccal Film or Diastat Rectal Gel in a randomized sequence following a moderate fat meal with a 28-day washout between doses. Subjects who completed Period 1 were asked to participate in a second period (Period 2) on a voluntary basis. Those subjects who agreed to participate in Period 2 received a second dose of DBF in exactly the same dose and manner as the earlier dose with the exception it was administered following a high fat meal.
| Arm | Type | Receives |
|---|---|---|
| Diazepam Buccal Film, Then Diastat Rectal Gel | Experimental | Drug: Diazepam Buccal Film, Drug: Diastat® Rectal Gel (Valeant Pharmaceuticals USA)Participants received a single dose of Diazepam Buccal Film following a moderate-fat meal and then received a single dose of Diastat Rectal Gel following a moderate-fat meal with a 28-day washout between doses. |
| Diastat Rectal Gel, Then Diazepam Buccal Film | Experimental | Drug: Diazepam Buccal Film, Drug: Diastat® Rectal Gel (Valeant Pharmaceuticals USA)Participants received a single dose of Diastat Rectal Gel following a moderate-fat meal and then received a single dose of Diazepam Buccal Film following a moderate-fat meal with a 28-day washout between doses. |
| Diazepam Buccal Film following a High-Fat Meal | Experimental | Drug: Diazepam Buccal FilmParticipants who volunteered to participate in the second period received a second dose of Diazepam Buccal Film at the same dose and exactly the same manner as the earlier dose with the exception that the dose was administered following ingestion of a high-fat meal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female, smoker (no more than 25 cigarettes or equivalent daily) or non-smoker, ≥ 18 and ≤ 65 years of age, with body weight between 38 and 111 kg, inclusive. Potential subjects with weights in the range of 112 to 134 kg (247 - 249 pounds) may be allowed to participate in the study at the discretion of the Principal Investigator.
- On a stable and ongoing regimen of at least one AED for treatment of epilepsy. Stable regimen is defined as no change in AED regimen for at least 30 days before the first study drug administration and no change anticipated in the prescribed AED regimen over the course of study participation.
- Subjects must have a diagnosis of seizure disorder (any seizure type or frequency) under treatment with at least one AED.
- Healthy (except for seizure disorder), according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Principal Investigator/Sub- Investigator.
- Clinical laboratory values within local laboratories acceptable ranges, unless values are deemed by the Principal Investigator/Sub-Investigator as "Not Clinically Significant".
Key exclusion criteria (40 listed)
- Clinically significant abnormal laboratory test results found during medical screening.
- Positive pregnancy test at screening.
- Known presence of any clinically significant: hepatic (e.g. hepatic impairment), renal/genitourinary (renal impairment, kidney stones), gastrointestinal (e.g. ulcerative colitis, ileus, partial or complete intestinal blockage, appendicitis), cardiovascular (e.g. uncontrolled hypertension), cerebrovascular, pulmonary, endocrine (controlled diabetes is acceptable), immunological, musculoskeletal, neurological (other than known seizure disorder), psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator and confirmed by Sponsor via written communication prior to subject enrollment.
- Presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the study drug experienced within 7 days prior to first study drug administration, as determined by the Principal Investigator/Sub-Investigator.
- Any clinically significant rectal abnormality by history or physical examination, or any condition, for which, in the judgment of the Principal Investigator/Sub-Investigator, administration of rectal gel would cause a potential risk to the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diazepam Buccal FilmAlso: DBFDiazepam Buccal Film administered on inner aspect of the cheek at the recommended dose regimen (10 mg to 17.5 mg according to body weight) following ingestion of a moderate fat meal and following ingestion of a high-fat meal. | Drug | Diastat Rectal Gel, Then Diazepam Buccal Film, Diazepam Buccal Film following a High-Fat Meal, Diazepam Buccal Film, Then Diastat Rectal Gel |
| Diastat® Rectal Gel (Valeant Pharmaceuticals USA)Also: DRGDiastat Rectal Gel administered rectally according to product label administration and dosing instructions (10 mg to 20 mg according to body weight) following ingestion of a moderate-fat meal. | Drug | Diastat Rectal Gel, Then Diazepam Buccal Film, Diazepam Buccal Film, Then Diastat Rectal Gel |
Primary outcome
AUC 0-t
Time frame: 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Area Under Plasma Concentration-Time Curve From Time Zero to the last non-zero concentration
AUC 0-inf
Time frame: 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Area under concentration time curve, from time 0 extrapolated to infinity
Cmax
Time frame: 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose
Maximum observed plasma concentration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Slatko, MD study chair
Aquestive Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Diazepam Buccal Film and Diastat® Rectal Gel (Valeant Pharmaceuticals USA) in people with Epilepsy, run by Aquestive Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC 0-t (time frame: 0.5, 0.75, 1, 105, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 192, and 240 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.