Seizure DisordersPhase 1NCT01116700
Dexmedetomidine in Seizure Patients
A Phase 1 study testing Dexmedetomidine in people with Seizure Disorders, run by University of California, San Francisco at 1 site in United States.
Trial summary
Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Seizure Disorders
- What is being tested?
- Dexmedetomidine
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65, BMI 20-25 kg/m2
- Anticonvulsant Group: Diagnosis of seizure disorder taking carbamazepine or phenytoin for a minimum of 2 weeks
- Control Group: Healthy volunteers taking no medications
Who cannot join
- Positive urine pregnancy test or lactating
- History of allergy to dexmedetomidine or alpha -2 agonists
- History of liver, renal or thyroid disease
- History of cardiovascular disease including history of arrhythmia or congestive heart failure
- History of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94122
About this study
Official title: The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders
Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. The investigators clinical experience suggests that these patients are resistant to the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic interaction between the anticonvulsant medications and dexmedetomidine or the higher dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic and pharmacodynamic differences of dexmedetomidine between patients receiving and not receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for these differences.
- Conditions
- Seizure Disorders
- Being tested
- Dexmedetomidine
- Keywords
- Epilepsy, Dexmedetomidine, Seizure
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of dexmedetomidine
Serum levels of dexmedetomidine will be taken at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Measured: 0-8 hour period
Secondary outcomes (4)
Patient State Index (PSI) and Entropy
PSI and/or state entropy will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Measured: 0-8h
Visual Analog Scale score
VAS scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Measured: 0-8h
Ramsay Sedation Score
Ramsay sedation scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Measured: 0-8h
Observer's Assessment of Alertness/Sedation Score (OAA/S)
OAA/S scores will be recorded at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
Measured: 0-8h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seizure DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alana M Flexman, MD, Principal investigator, UCSF Department of AnesthesiaPekka Talke, MD, Principal investigator, UCSF Department of AnesthesiaPaul Garcia, MD, Principal investigator, UCSF Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116700
- Sponsor's protocol ID
- UCSF-AF-02-2010
- Status last verified
- Aug 2013
- First submitted
- 3 May 2010
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sleigh JW, Vacas S, Flexman AM, Talke PO. Electroencephalographic Arousal Patterns Under Dexmedetomidine Sedation. Anesth Analg. 2018 Oct;127(4):951-959. doi: 10.1213/ANE.0000000000003590.
PubMed 29933272
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Patients With Seizure Disorders
- ClinicalTrials.gov ID
- NCT01116700
- Acronym / sponsor ID
- UCSF-AF-02-2010
- Conditions
- Seizure Disorders
- Keywords
- Epilepsy, Dexmedetomidine, Seizure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dexmedetomidine is an alpha-2 agonist commonly used during neurosurgery due to its unique properties as a sedative and anxiolytic with minimal respiratory depression. Neurosurgical patients frequently come to the operating room on anticonvulsant therapy with a history of seizures. The investigators clinical experience suggests that these patients are resistant to the sedative effects of dexmedetomidine. This effect may represent a pharmacokinetic interaction between the anticonvulsant medications and dexmedetomidine or the higher dexmedetomidine dose requirement could result from abnormal pharmacodynamics due to the underlying seizure disorder. The investigators study aims to investigate the pharmacokinetic and pharmacodynamic differences of dexmedetomidine between patients receiving and not receiving enzyme-inducing anticonvulsant therapy and to identify a potential mechanism for these differences.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65, BMI 20-25 kg/m2
- Anticonvulsant Group: Diagnosis of seizure disorder taking carbamazepine or phenytoin for a minimum of 2 weeks
- Control Group: Healthy volunteers taking no medications
Key exclusion criteria (5 listed)
- Positive urine pregnancy test or lactating
- History of allergy to dexmedetomidine or alpha -2 agonists
- History of liver, renal or thyroid disease
- History of cardiovascular disease including history of arrhythmia or congestive heart failure
- History of drug or alcohol abuse
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group) | Drug | – |
Primary outcome
Serum level of dexmedetomidine
Time frame: 0-8 hour period
Serum levels of dexmedetomidine will be taken at specific intervals during and after a step-wise computer controlled infusion of dexmedetomidine.
4 secondary outcomes
Patient State Index (PSI) and Entropy
Time frame: 0-8h
Visual Analog Scale score
Time frame: 0-8h
Ramsay Sedation Score
Time frame: 0-8h
Observer's Assessment of Alertness/Sedation Score (OAA/S)
Time frame: 0-8h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
- Derived from this study: PubMed 29933272Sleigh JW, Vacas S, Flexman AM, Talke PO. Electroencephalographic Arousal Patterns Under Dexmedetomidine Sedation. Anesth Analg. 2018 Oct;127(4):951-959. doi: 10.1213/ANE.0000000000003590.
Related trials for Seizure Disorders
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.
Alana M Flexman, MD principal investigator
UCSF Department of Anesthesia
Pekka Talke, MD principal investigator
UCSF Department of Anesthesia
Paul Garcia, MD principal investigator
UCSF Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine in people with Seizure Disorders, run by University of California, San Francisco at 1 site 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 3 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: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum level of dexmedetomidine (time frame: 0-8 hour period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116700, which also lists 1 linked publication.
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 9 Aug 2013.