Neuralgia, PostherpeticPhase 2/3NCT00295776
Lamictal in the Treatment of Post-Herpetic Neuralgia
A Phase 2/3 study testing Lamictal in the treatment of Post-Herpetic Neuralgia in people with Neuralgia, Postherpetic, run by George Washington University at 1 site in United States.
Trial summary
To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuralgia, Postherpetic
- What is being tested?
- Lamictal in the treatment of Post-Herpetic Neuralgia
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 2007
- Phase
- Phase 2/3
- 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 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- All patients will be over the age of 18,
- Need to have a diagnosis of Post-Herpetic Neuralgia,
- Minimum of 4 on the Likert Pain Scale,
- If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks
Who cannot join
- Currently on any antiepileptic drugs (AED), except for Gabapentin.
- Currently taking opioid or unwilling to washout prior to the study,
- Pregnant and lactating,
- Have active severe systemic disease,
- History of Stevens-Johnson syndrome or TEN,
- Clinically significant abnormal lab values,
Show all 12Show fewer
- Known drug allergy to Lamictal,
- Patients on Fibrates (Tricor and Lopid),
- History of major psychiatric disturbance and substance abuse.
- Valproate due to increase chances of severe rash,
- Lidocaine Patch,
- Use of hormonal contraceptives (birth control pills, patch, ring, injection)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study
To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia.
- Conditions
- Neuralgia, Postherpetic
- Being tested
- Lamictal in the treatment of Post-Herpetic Neuralgia
- Keywords
- Inclusion Criteria:Minimum of 4 on the Likert Pain Scale.If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks., Exclusion Criteria:, Currently on any antiepilepic drugs (AED), except for Gabapentin., Currently taking opioid or unwilling to washout prior to the study,, Pregnant and lactating,, Have active severe systemic disease,, History of Stevens-Johnson syndrome or TEN,
- Medical subject headings
- Neuralgia, Postherpetic, Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamictal in the treatment of Post-Herpetic NeuralgiaDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2005
- Primary completionDec 2007
Why it stopped: enrollment difficult due to inclusion/exclusion criteria/protocol requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuralgia, PostherpeticStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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 2/3
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Perry K. Richardson, M.D., Principal investigator, The George Washington University Medical Faculty Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295776
- Sponsor's protocol ID
- Lamictal PHN
- Status last verified
- Feb 2005
- First submitted
- 22 Feb 2006
- Last updated
- 13 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study
- ClinicalTrials.gov ID
- NCT00295776
- Acronym / sponsor ID
- Lamictal PHN
- Conditions
- Neuralgia, Postherpetic
- Keywords
- Inclusion Criteria:Minimum of 4 on the Likert Pain Scale.If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks., Exclusion Criteria:, Currently on any antiepilepic drugs (AED), except for Gabapentin., Currently taking opioid or unwilling to washout prior to the study,, Pregnant and lactating,, Have active severe systemic disease,, History of Stevens-Johnson syndrome or TEN,
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment difficult due to inclusion/exclusion criteria/protocol requirements
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2005
- Primary completion
- Dec 2007 (actual)
- First posted
- 24 Feb 2006 (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.
To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients will be over the age of 18,
- Need to have a diagnosis of Post-Herpetic Neuralgia,
- Minimum of 4 on the Likert Pain Scale,
- If currently taking TCA and/or Gabapentin, need to have been on stable dose for minimum of 4 weeks
Key exclusion criteria (12 listed)
- Currently on any antiepileptic drugs (AED), except for Gabapentin.
- Currently taking opioid or unwilling to washout prior to the study,
- Pregnant and lactating,
- Have active severe systemic disease,
- History of Stevens-Johnson syndrome or TEN,
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 |
|---|---|---|
| Lamictal in the treatment of Post-Herpetic Neuralgia | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: enrollment difficult due to inclusion/exclusion criteria/protocol requirements). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
Related trials for Neuralgia, Postherpetic
Not yet recruitingPhase 1
Simultaneous Engagement of Networks for Alleviating Pain (SENAP)
Neuropathic Pain, Postherpetic Neuralgia
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruitingObservational study
Obesity and Obesity-Related Factors and Risk of Herpes Zoster (Shingles) and Postherpetic Neuralgia
Herpes Zoster (HZ)
Recruiting
The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster
Herpes Zoster, Pain
Not yet recruiting
Efficacy and Safety of Intravenous Dexamethasone Palmitate Treatments in Acute and Subacute Herpes Zoster Pain
Herpes Zoster Pain
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.
Perry K. Richardson, M.D. principal investigator
The George Washington University Medical Faculty Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lamictal in the treatment of Post-Herpetic Neuralgia in people with Neuralgia, Postherpetic, run by George Washington University 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 4 inclusion and 12 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 13 Mar 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: enrollment difficult due to inclusion/exclusion criteria/protocol requirements). Results are not available in the source record.
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.
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 13 Mar 2013.