NCT00168441

Brief Summary

4-month study including a 30-day baseline phase

Trial Health

100
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_2

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

June 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

September 12, 2005

Last Update Submit

May 27, 2011

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

  • Pain score

Secondary Outcomes (2)

  • Various Quality of Life questionnaires

  • Reduction in area of pain/allodynia

Interventions

Botulinum Toxin Type ADRUG

Eligibility Criteria

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

You may qualify if:

  • Postherpetic neuralgia for more than 3 months after the healing of a herpes zoster skin rash.

You may not qualify if:

  • Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 30, 2011

Record last verified: 2011-05