Postherpetic NeuralgiaPhase 4NCT00527202
Efficacy Study of Botox to Treat Neuropathic Pain
A Phase 4 study testing botulinum toxin A in people with Postherpetic Neuralgia and Nerve Trauma, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia, Nerve Trauma
- What is being tested?
- botulinum toxin A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2004to Mar 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia
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)
Read the detailed description
The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.
- Conditions
- Postherpetic Neuralgia, Nerve Trauma
- Being tested
- botulinum toxin A
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin ADrug
Also called saline (placebo)
Botulinum toxin A versus saline in parallel groups
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: botulinum toxin A |
| placebo | Placebo comparator | saline injection with the same dosages injected using the same procedure as botulinum toxin A Receives: Drug: botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported pain (numerical scales) on patients diaries
pain intensity on numerical rating scales
Measured: prospective
Secondary outcomes (1)
mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness
VAS for pain intensity
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startJun 2004
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine ATTAL, Hospital Ambroise Paré Paris
- Investigators
- Didier BOUHASSIRA, MD, PHD, Study director, INSERM U 792Danièle RANOUX, MD, Study chair, hôpital de Limoges (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527202
- Sponsor's protocol ID
- BTXneurop-1
- Status last verified
- Apr 2021
- First submitted
- 7 Sep 2007
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Study of the Efficacy of Botulinum Toxin Type A (Botox) in Spontaneous Pain and Allodynia Related to Traumatic Nerve Injury or Postherpetic Neuralgia
- ClinicalTrials.gov ID
- NCT00527202
- Acronym / sponsor ID
- BTXneurop-1
- Conditions
- Postherpetic Neuralgia, Nerve Trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Jun 2004 (actual)
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The study will be randomized, performed in parallel group and double blind versus saline and will include 30 patients. Botulinum toxin injection will be injected intradermally in the painful area (one single injection) following a method adapted from that used in hyperhidrosis. The patients will be followed for 6 months after the injection. Primary outcome will be self-reported pain from the patients diaries. Secondary outcomes will be neuropathic symptoms, quality of life, allodynia to brush and pressure, detection and pain thresholds, proportion of responders, pain relief and clinical global impression. Clinical assessment will take place before injection then at 1 month, 3 months and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin A | Experimental | Drug: botulinum toxin Aactive treatment arm using botulinum toxin A max 200 U injected into the painful area using SC injections 2 cm apart |
| placebo | Placebo comparator | Drug: botulinum toxin Asaline injection with the same dosages injected using the same procedure as botulinum toxin A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- contraindication to BTXA formulation
- coagulation disorders
- another painful condition
- current major depression
- history of drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| botulinum toxin AAlso: saline (placebo)Botulinum toxin A versus saline in parallel groups | Drug | botulinum toxin A, placebo |
Primary outcome
Self-reported pain (numerical scales) on patients diaries
Time frame: prospective
pain intensity on numerical rating scales
1 secondary outcome
mean pain (VAS) at each visit Quality of life Proportion of responders % pain relief Clinical global impression Assessment of blindedness
Time frame: prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier BOUHASSIRA, MD, PHD study director
INSERM U 792
Danièle RANOUX, MD study chair
hôpital de Limoges (FRANCE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing botulinum toxin A in people with Postherpetic Neuralgia and Nerve Trauma, run by Hospital Ambroise Paré Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain (numerical scales) on patients diaries (time frame: prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.