EpilepsyPhase 4NCT01309074
Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
A Phase 4 study testing Pregabalin-Lyrica and Sertraline in people with Epilepsy and Anxiety, run by Rush University Medical Center at 1 site in United States.
Trial summary
The aim of the study is to compare the safety \& efficacy of sertraline (up to a dose of 200mg/day) \& pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Pregabalin-Lyrica and Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2012
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GAD-7 total score above 10.
- Have a diagnosis of a Partial Seizure Disorder.
- Have a Hamilton-A total score 20 and above.
- 18-80 years of age.
- Able to read at a fourth grade level.
- If a woman of childbearing age, agrees to use an acceptable means of birth control.
Who cannot join
- Unable to understand and sign a consent.
- Unable to follow instructions for the study.
- Displaying current suicidal ideation
- Having psychogenic non-epileptic seizures
- Have a history of drug or alcohol abuse.
- Use of any investigational drug within the last 30 days.
- Hypersensitivity reaction or other serious adverse event to PGB in prior trials.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The aim of the study is to compare the safety \& efficacy of sertraline (up to a dose of 200mg/day) \& pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy.
Read the detailed description
Patients with epilepsy will be treated with either sertraline (up to a dose of 200mg/day) or pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety. Outcome measures will include changes in the anxiety severity scales.
- Being tested
- Pregabalin-Lyrica, Sertraline
- Keywords
- Anxiety, Epilepsy
- Medical subject headings
- Epilepsy, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin-LyricaDrug
Also called Lyrica.
Pregabalin in a dose up to 300mg/day in BID dosing.
SertralineDrug
Also called Zoloft.
Sertraline in a dose up to 200mg/day in BID dosing.
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Pregabalin is an antiepileptic medication which has been found in double blind placebo controlled trials to be effective and safe in the treatment of primary generalized anxiety disorder. It has an indication for the treatment of this condition in Europe \& Canada but not in the US. Receives: Drug: Pregabalin-Lyrica |
| Sertraline | Active comparator | Sertraline is an SSRI found to be an effective treatment of generalized anxiety disorder in controlled trials. It does not have an indication for this in this country. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.
Change in severity of symptoms \&/o remission of symptoms of anxiety between visit 0 \& the end of treatment phase.
Measured: 27 weeks
Secondary outcomes (1)
Change in Quality of life measures assessed with the QOLIE-89.
A change in the total scores of the QOLIE-89 scores as well as in the individual subscales and change in the tolerance of antiepileptic medication assessed with change in the total score of the adverse event profile between baseline \& the end of treatment phase.
Measured: 27 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: No subjects could be enrolled and therefore we decided to withdraw/stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andre M. Kanner, MD, Principal investigator, Director Laboratory Encephalography
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309074
- Sponsor's protocol ID
- GA0082BY
- Status last verified
- Jan 2023
- First submitted
- 2 Mar 2011
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
- ClinicalTrials.gov ID
- NCT01309074
- Acronym / sponsor ID
- GA0082BY
- Keywords
- Anxiety, Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects could be enrolled and therefore we decided to withdraw/stop the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Mar 2011 (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.
The aim of the study is to compare the safety \& efficacy of sertraline (up to a dose of 200mg/day) \& pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy.
Detailed description
Patients with epilepsy will be treated with either sertraline (up to a dose of 200mg/day) or pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety. Outcome measures will include changes in the anxiety severity scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: Pregabalin-LyricaPregabalin is an antiepileptic medication which has been found in double blind placebo controlled trials to be effective and safe in the treatment of primary generalized anxiety disorder. It has an indication for the treatment of this condition in Europe \& Canada but not in the US. |
| Sertraline | Active comparator | Drug: SertralineSertraline is an SSRI found to be an effective treatment of generalized anxiety disorder in controlled trials. It does not have an indication for this in this country. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- GAD-7 total score above 10.
- Have a diagnosis of a Partial Seizure Disorder.
- Have a Hamilton-A total score 20 and above.
- 18-80 years of age.
- Able to read at a fourth grade level.
Key exclusion criteria (7 listed)
- Unable to understand and sign a consent.
- Unable to follow instructions for the study.
- Displaying current suicidal ideation
- Having psychogenic non-epileptic seizures
- Have a 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 |
|---|---|---|
| Pregabalin-LyricaAlso: Lyrica.Pregabalin in a dose up to 300mg/day in BID dosing. | Drug | Pregabalin |
| SertralineAlso: Zoloft.Sertraline in a dose up to 200mg/day in BID dosing. | Drug | Sertraline |
Primary outcome
Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.
Time frame: 27 weeks
Change in severity of symptoms \&/o remission of symptoms of anxiety between visit 0 \& the end of treatment phase.
1 secondary outcome
Change in Quality of life measures assessed with the QOLIE-89.
Time frame: 27 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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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.
Andre M. Kanner, MD principal investigator
Director Laboratory Encephalography
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin-Lyrica and Sertraline in people with Epilepsy and Anxiety, run by Rush University Medical Center 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 2 Feb 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A. (time frame: 27 weeks). 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 2 Feb 2023.