EpilepsyPhase 2NCT00594945
Study of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
A Phase 2 study testing Clonazepam in people with Epilepsy, run by Jazz Pharmaceuticals at 6 sites in 2 countries.
Trial summary
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Clonazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Dec 2007to Jun 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of refractory epilepsy
- No Nasal conditions that would preclude the use of intranasal product
Who cannot join
- Subject with a clinical significant unstable medical abnormality
- Subject currently or regularly taking Clonazepam
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Mid-Atlantic Epilepsy & Sleep Center
Bethesda, Maryland, 20817
Ohio State University
Columbus, Ohio, 43210
Neurological Clinic of Texas, PA
Dallas, Texas, 75232
Clinical Trials. inc.
Little Rock, Arkansas, 72205
Columbia Comprehensive Epilepsy Center, Neurological Institute
New York, New York, 10032
About this study
Official title: A Phase 2a, Open-label,Proof -Of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
- Conditions
- Epilepsy
- Being tested
- Clonazepam
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonazepamDrug
1 Dose
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Clonazepam 2 mg | Experimental | Not described Receives: Drug: Clonazepam |
| Intranasal Clonazepam 3 mg | Experimental | Not described Receives: Drug: Clonazepam |
| Intranasal Clonazepam both Dose Groups 2 mg & 3 mg | Experimental | Not described Receives: Drug: Clonazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.
Measured: Change from baseline to treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionJun 2009
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.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beverly Benson, PhD, Study director, Jazz Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594945
- Sponsor's protocol ID
- 07-001
- Status last verified
- May 2014
- First submitted
- 7 Jan 2008
- Last updated
- 1 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Open-label,Proof -Of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects With Epileptic Seizures
- ClinicalTrials.gov ID
- NCT00594945
- Acronym / sponsor ID
- 07-001
- Conditions
- Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Posted 1 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and efficacy of intranasal Clonazepam in subjects with epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal Clonazepam 2 mg | Experimental | Drug: Clonazepam |
| Intranasal Clonazepam 3 mg | Experimental | Drug: Clonazepam |
| Intranasal Clonazepam both Dose Groups 2 mg & 3 mg | Experimental | Drug: Clonazepam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of refractory epilepsy
- No Nasal conditions that would preclude the use of intranasal product
Key exclusion criteria (2 listed)
- Subject with a clinical significant unstable medical abnormality
- Subject currently or regularly taking Clonazepam
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 |
|---|---|---|
| Clonazepam1 Dose | Drug | Intranasal Clonazepam 2 mg, Intranasal Clonazepam 3 mg, Intranasal Clonazepam both Dose Groups 2 mg & 3 mg |
Primary outcome
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%).
Time frame: Change from baseline to treatment day
Summary of video EEG number of spikes and sharp waves. Over a 24 hour period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Beverly Benson, PhD study director
Jazz Pharmaceuticals
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clonazepam in people with Epilepsy, run by Jazz Pharmaceuticals at 6 sites in 2 countries.
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 2 inclusion and 2 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 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Finland. 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 1 Jul 2014). 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?
Number of Spikes and Sharp Waves, Relative Change From Baseline to Treatment Day (%). (time frame: Change from baseline to treatment day). 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 1 Jul 2014.