NCT01752699

Brief Summary

Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
15 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

15.1 years

First QC Date

December 11, 2012

Last Update Submit

March 14, 2013

Conditions

Post-herpetic Neuralgia

Keywords

neuropathic pain,post-herpetic neuralgia,methadone,

Outcome Measures

Primary Outcomes (1)

  • Change in baseline Pain

    Assessing by verbal analog scale (VAS)

    baseline (visit inclusion) and three moths latter

Study Arms (2)

Methadone

EXPERIMENTAL

in this arm patients will take methadone 5mg.

Drug: Methadone

Placebo

EXPERIMENTAL

in this arm patients will take placebo pills.

Drug: Placebo

Interventions

MethadoneDRUG

patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.

Methadone
PlaceboDRUG

patients with post-herpetic neuralgia take placebo to treat the pain symptoms.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic (\>6 months) symptomatic PHN
  • with visual analogical scale \>40/100mm
  • use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)

You may not qualify if:

  • Don't full the criteria above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Teixeira MJ, Okada M, Moscoso AS, Puerta MY, Yeng LT, Galhardoni R, Tengan S, Andrade DC. Methadone in post-herpetic neuralgia: A pilot proof-of-concept study. Clinics (Sao Paulo). 2013 Jul;68(7):1057-60. doi: 10.6061/clinics/2013(07)25.

    PMID: 23917673DERIVED

MeSH Terms

Conditions

Neuralgia, PostherpeticNeuralgia

Interventions

Methadone

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 19, 2012

Study Start

January 1, 1998

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

March 18, 2013

Record last verified: 2013-03