Lamictal in the Treatment of Post-Herpetic Neuralgia | NCT00295776

Studies
Lamictal in the Treatment of Post-Herpetic Neuralgia

NCT00295776

Sponsor

George Washington University

Status

Terminated

Last Update Posted

Mar 13, 2013Estimated

Enrollment

Not provided

Phase

Phase 2Phase 3

Conditions

Neuralgia, Postherpetic

Interventions

Lamictal in the treatment of Post-Herpetic Neuralgia

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

enrollment difficult due to inclusion/exclusion criteria/protocol requirements

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Not provided

First Submitted Date

Feb 22, 2006

First Submission Date that Met QC Criteria

Feb 22, 2006

First Posted Date

Feb 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2013

Last Update Posted Date

Mar 13, 2013Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Conditions Module

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,

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Lamictal in the treatment of Post-Herpetic Neuralgia	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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,
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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Perry K. Richardson, M.D.	The George Washington University Medical Faculty Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Faculty Associates		Washington D.C.	District of Columbia	20037	United States

Condition Browse Module

MeSH Terms

ID	Term
D051474	Neuralgia, Postherpetic
D013262	Stevens-Johnson Syndrome

Ancestor Terms

ID	Term
D009437	Neuralgia
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077213	Lamotrigine

Ancestor Terms

ID	Term
D014227	Triazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided