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NCT00295776 Clinical Trial

Lamictal in the Treatment of Post-Herpetic Neuralgia

Neuralgia, Postherpetic Clinical Trial

Official title:
Lamictal in the Treatment of Post-Herpetic Neuralgia-A Safety, Efficacy,Randomized, Double Blind, Placebo Controlled, Cross-Over Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00295776
Other study ID # Lamictal PHN
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received February 22, 2006
Last updated March 11, 2013
Start date February 2005

Study information
Verified date February 2005
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To assess the efficacy of Lamictal for the treatment of pain and reduction of allodynia in patients with post herpetic neuralgia.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date December 2007
Accepts healthy volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Lamictal in the treatment of Post-Herpetic Neuralgia

Locations
Country Name City State
United States Medical Faculty Associates Washington DC District of Columbia

Sponsors (2)
Lead Sponsor Collaborator
George Washington University GlaxoSmithKline

Country where clinical trial is conducted

United States, 

See also
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Terminated NCT00964990 - A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Patients With Neuropathic Pain (Postherpetic Neuralgia and Post-traumatic Neuralgia) Phase 2
Completed NCT00394901 - A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia Phase 3
Completed NCT01252160 - Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage Phase 4
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Completed NCT00160667 - A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia) Phase 2
Terminated NCT00245544 - Safety and Preliminary Efficacy of MK0759 in Postherpetic Neuralgia (PHN)(0759-004) Phase 2
Completed NCT00335933 - Safety and Efficacy of Gabapentin in Postherpetic Neuralgia Phase 3
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Completed NCT01129531 - A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia Phase 2
Completed NCT00674687 - A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing N/A
Terminated NCT01678924 - A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia Phase 2
Completed NCT00424372 - A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia Phase 3
Completed NCT00619476 - A Study In Patients With Neuropathic Pain From Post-Herpetic Neuralgia (PHN) Phase 2
Completed NCT00570310 - Neuropathic Pain Syndrome Patient Study (MK-0000-072) Phase 1
Terminated NCT00282763 - A Research Study to Evaluate the Safety and Effectiveness of MK0686 for the Treatment of Postherpetic Neuralgia (Also Known as PHN or Post Shingles Pain) (0686-005) Phase 2
Completed NCT00568321 - RN624 For Pain Of Post-Herpetic Neuralgia Phase 2
Not yet recruiting NCT01102101 - Effect of Opioids in Neuropathic Pain in Postherpetic Patients Phase 3
Completed NCT00614705 - PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia Phase 2