EpilepsyPhase 2NCT02316847
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use of Diazepam Nasal Spray.
A Phase 2 study testing diazepam nasal spray in people with Epilepsy, run by Acorda Therapeutics at 33 sites in United States.
Trial summary
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste). Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- diazepam nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 33 sitesUnited States
- Study dates
- Dec 2014to Sep 2016
- Phase
- Phase 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of drug-resistant epilepsy
- Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
- Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
- A caregiver must consent to participate together with the subject for purposes of observation and data collection
- The caregiver must be present when the investigational product is administered
- Screening body weight between 26 to 111 kg, inclusive
Who cannot join
- Female subject who is pregnant, breastfeeding, or planning to become pregnant
- Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
- Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
- Positive screening test for ethanol or other drugs of abuse
- Unable to receive medications intranasally
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Acorda Site #226
Ames, Iowa, 50010
Acorda Site #217
Augusta, Georgia, 30912
Acorda Site #202
Bethesda, Maryland, 20817
Acorda Site #212
Boston, Massachusetts, 02115
Acorda Site #214
Boston, Massachusetts, 02115
Acorda Site #208
Boston, Massachusetts, 02215
Acorda Site #203
Charleston, South Carolina, 29425
Acorda Site #221
Dallas, Texas, 75251
Acorda Site #225
Fort Wayne, Indiana, 46804
Acorda Site #222
Hackensack, New Jersey, 07601
Acorda Site #232
Honolulu, Hawaii, 96817
Acorda Site #229
Houston, Texas, 77030
Acorda Site #216
Kansas City, Missouri, 64111
Acorda Site #204
Little Rock, Arkansas, 72205
Acorda Site #213
Los Angeles, California, 90095
Acorda Site #210
Madison, Wisconsin, 53792
Acorda Site #235
Memphis, Tennessee, 38103
Acorda Site #218
Nashville, Tennessee, 37232
Acorda Site #223
New York, New York, 10016
Acorda Site #220
Orange, California, 92868
Acorda Site #206
Orlando, Florida, 32819
Acorda Site #219
Philadelphia, Pennsylvania, 19104
Acorda Site #237
Philadelphia, Pennsylvania, 19107
Acorda Site #227
Phoenix, Arizona, 85054
Acorda Site #241
Port Charlotte, Florida, 33592
Acorda Site #230
Portland, Oregon, 97239
Acorda Site #224
Renton, Washington, 98057
Acorda Site #215
Richmond, Virginia, 23298
Acorda Site #233
Rochester, New York, 14642
Acorda Site #205
St Louis, Missouri, 63131
Acorda Site #231
Tallahassee, Florida, 32308
Acorda Site #201
Tampa, Florida, 33606
Acorda Site #234
Tampa, Florida, 33609
About this study
Official title: Multi-center, Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Adolescents and Adult Patients With Cluster Seizures, Including Assessment of Olfaction and Reported Changes in Taste.
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
- Conditions
- Epilepsy
- Being tested
- diazepam nasal spray
- Keywords
- Cluster Seizures, Seizures, Clusters, Acute repetitive seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diazepam nasal sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| diazepam nasal spray (Adults) | Experimental | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. Receives: Drug: diazepam nasal spray |
| Diazepam Nasal Spray (Adolescents) | Experimental | One dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. Receives: Drug: diazepam nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory Changes as Measured by the Smell Identification Test (SIT)
The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5.
Measured: Screening, weeks 12, 24, 36, 48 and 51
Change From Baseline (Screening) in Nasal Mucosa.
Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation."
Measured: Screening, Weeks 12, 24, 36, 48 and 51
Change in Taste as Measured by a Taste Change Questionnaire
Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10).
Measured: Weeks 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2016
- Study completionSep 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acorda Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MinJae Lee, Study director, SK Biopharmaceuticals Co, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316847
- Sponsor's protocol ID
- DZNS-EP-1025
- Status last verified
- Jul 2018
- First submitted
- 9 Dec 2014
- Last updated
- 30 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open-label, Study of Safety and Tolerability of Chronic Intermittent Usage of Diazepam Nasal Spray in Adolescents and Adult Patients With Cluster Seizures, Including Assessment of Olfaction and Reported Changes in Taste.
- ClinicalTrials.gov ID
- NCT02316847
- Acronym / sponsor ID
- DZNS-EP-1025
- Conditions
- Epilepsy
- Keywords
- Cluster Seizures, Seizures, Clusters, Acute repetitive seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Acorda TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Posted 30 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess long-term safety and tolerability of repeat dose diazepam nasal spray in adolescents and adults with cluster seizures, with a focus on potential local effects (changes in nasal mucosa, olfaction, and taste).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diazepam nasal spray (Adults) | Experimental | Drug: diazepam nasal sprayOne dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
| Diazepam Nasal Spray (Adolescents) | Experimental | Drug: diazepam nasal sprayOne dose of diazepam nasal spray is two intranasal sprays; one in each nostril using a nasal spray device. The dose is administered while the subject is sitting up or lying down. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of drug-resistant epilepsy
- Patients who experience multiple episodes of acute repetitive seizures requiring at least one concomitant antiepileptic drug (AED)
- Occurrence of at least 3 seizure clusters within the past 12 months, including at least one cluster in the 4 months prior to the Screening Visit
- A caregiver must consent to participate together with the subject for purposes of observation and data collection
- The caregiver must be present when the investigational product is administered
Key exclusion criteria (5 listed)
- Female subject who is pregnant, breastfeeding, or planning to become pregnant
- Presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam
- Known allergy or hypersensitivity to diazepam, related drugs, or any of the formulation components
- Positive screening test for ethanol or other drugs of abuse
- Unable to receive medications intranasally
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 nasal spray | Drug | Diazepam Nasal Spray (Adolescents), diazepam nasal spray (Adults) |
Primary outcome
Olfactory Changes as Measured by the Smell Identification Test (SIT)
Time frame: Screening, weeks 12, 24, 36, 48 and 51
The SIT is a 50-item multiple-choice standardized test of olfactory function. Scoring of the test in the ability to smell ranges from normal (Normosmia: score 35 - 40 Women; 34 - 40 Men); to inability to smell (Anosmia score 6 - 18); or Malingering (not engaged in the test) ranges 0 - 5.
Change From Baseline (Screening) in Nasal Mucosa.
Time frame: Screening, Weeks 12, 24, 36, 48 and 51
Change from baseline treatment visits using a focused nasal exam was based on a scale of nasal irritation "none" to Grade 4 "septal perforation."
Change in Taste as Measured by a Taste Change Questionnaire
Time frame: Weeks 12, 24
Change in taste questionnaire was administered to subjects at every study visit only if the subject complained of a change in taste or as needed to report a related AE. The taste change profile included sweet, salty, sour, bitter, oily, sharp, chalky, metallic. The subject rated the change on a 10-point scale ranging from a weak change (1) to very strong (10).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
MinJae Lee study director
SK Biopharmaceuticals Co, Ltd
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diazepam nasal spray in people with Epilepsy, run by Acorda Therapeutics at 33 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 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 phase mean?
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 30 Jul 2018). 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?
Olfactory Changes as Measured by the Smell Identification Test (SIT) (time frame: Screening, weeks 12, 24, 36, 48 and 51). 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 30 Jul 2018.