NCT00527202

Brief Summary

Objectives : to investigate the analgesic effects and safety of intradermal botulinum toxin A injection in the treatment of focal painful neuropathies (eg, postherpetic neuralgia, nerve trauma)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

2.7 years

First QC Date

September 7, 2007

Last Update Submit

April 29, 2021

Conditions

Postherpetic NeuralgiaNerve Trauma

Outcome Measures

Primary Outcomes (1)

  • Self-reported pain (numerical scales) on patients diaries

    pain intensity on numerical rating scales

    prospective

Secondary Outcomes (1)

  • mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness

    prospective

Study Arms (2)

botulinum toxin A

EXPERIMENTAL

active treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart

Drug: botulinum toxin A

placebo

PLACEBO COMPARATOR

saline injection with the same dosages injected using the same procedure as botulinum toxin A

Drug: botulinum toxin A

Interventions

botulinum toxin ADRUG

Botulinum toxin A versus saline in parallel groups

Also known as: saline (placebo)
botulinum toxin Aplacebo

Eligibility Criteria

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

You may qualify if:

  • daily pain for at least 6 months of at least moderate intensity clearly attributed to the nerve lesion
  • limited area of pain
  • mechanical allodynia in the painful area

You may not qualify if:

  • contraindication to BTXA formulation
  • coagulation disorders
  • another painful condition
  • current major depression
  • history of drug or alcohol abuse
  • compensation claim or litigation
  • facial neuropathic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Ambroise Paré, AP-HP

Boulogne-Billancourt, 92100f, France

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Botulinum Toxins, Type ASodium Chloride

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 FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Didier BOUHASSIRA, MD, PHD

    INSERM U 792

    STUDY DIRECTOR

  • Danièle RANOUX, MD

    hôpital de Limoges (FRANCE)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD coordinator

Study Record Dates

First Submitted

September 7, 2007

First Posted

September 10, 2007

Study Start

June 1, 2004

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

FR(1)