PainNCT00822926

Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

A study testing Botulinum Toxin Type A and Saline in people with Pain, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Pain
What is being tested?: Botulinum Toxin Type A and Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Dec 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy, excluding botox injection
The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
Patient reports more than 3 weeks of greater than 50% pain relief from previous botox injection
The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar in the absence of the botox injection
Age 18-100
Ability to read, write, and converse in English, provide informed consent, and follow study procedures

Who cannot join

Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
Any ongoing legal action related to their pain
Allergy to local anesthetics
Any ongoing disability claim
Currently being treated for any severe psychiatric disorder, including anxiety or depression
History of any adverse reaction to botulinum toxin

Show all 11Show fewer

History of botulism
Untreated infection
Coagulopathy
(Females) - positive pregnancy test
Surgery in the last 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. the investigators propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).

Read the detailed description

Patients with post-herpetic neuralgia, complex regional pain syndrome, and post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice the investigators have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A.

Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results.

A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.

Conditions: Pain
Being tested: Botulinum Toxin Type A, Saline
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum Toxin Type ADrug
Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
SalineDrug
Subcutaneous injection of saline into scar tissue

Study groups in NCT00822926
Study group	Role	What they receive
Placebo then Botox	Experimental	Injection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Receives: Drug: Botulinum Toxin Type A; Drug: Saline
Botox then Placebo	Experimental	Injection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue Receives: Drug: Botulinum Toxin Type A; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Analgesic Failure
Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.
Measured: Duration of trial (2-20 months, depending on how long pain relief lasts)

Secondary outcomes (2)

Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines
The Beck Depression Inventory was used to assess psychosocial function. Scores were measured at baseline, their final questionnaire following the first injection visit, and their final questionnaire following their second injection visit. Scores range from 0-63, with lower scores representing less severe depression symptoms and higher scores representing more severe depression symptoms.
Measured: Duration of trial (2-20 months, depending on how long pain relief lasts)
NRS Score Three Weeks After Injection
Pain scores were measured at baseline, 3 weeks after placebo, and 3 weeks after botox. Scores range from 0 (no pain) to 10 (severe, disabling pain).
Measured: 3 weeks after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Dec 2013

First posted15 Jan 2009 (estimated)
Study startJan 2009
Primary completionDec 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00822926
Sponsor's protocol ID: SU-01072009-1499
Other IDs: 15601
Status last verified: Jul 2017
First submitted: 14 Jan 2009
Last updated: 15 Aug 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial
ClinicalTrials.gov ID: NCT00822926
Acronym / sponsor ID: SU-01072009-1499
Conditions: Pain
Study type: Interventional
Recruitment status: Terminated
Enrolment: 5 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: Jan 2009
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 15 Jan 2009 (estimated)
Results: Posted 15 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Placebo then Botox	Experimental	Drug: Botulinum Toxin Type A, Drug: SalineInjection 1: Saline- Subcutaneous injection of saline into scar tissue Injection 2: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
Botox then Placebo	Experimental	Drug: Botulinum Toxin Type A, Drug: SalineInjection 1: Botulinum Toxin Type A- Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue Injection 2: Saline- Subcutaneous injection of saline into scar tissue

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy, excluding botox injection
The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
Patient reports more than 3 weeks of greater than 50% pain relief from previous botox injection
The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar in the absence of the botox injection
Age 18-100

Key exclusion criteria (11 listed)

Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
Any ongoing legal action related to their pain
Allergy to local anesthetics
Any ongoing disability claim
Currently being treated for any severe psychiatric disorder, including anxiety or depression

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 Type APatients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue	Drug	Botox then Placebo, Placebo then Botox
SalineSubcutaneous injection of saline into scar tissue	Drug	Botox then Placebo, Placebo then Botox

Primary outcome

Time to Analgesic Failure
Time frame: Duration of trial (2-20 months, depending on how long pain relief lasts)
Participants completed the Pain Numeric Rating Scale everyday after the injections. Outcome measure represents the number of days before pain returned to baseline levels.

2 secondary outcomes

Improvement in Psychosocial Function as Assessed by Outcomes as Dictated by the IMMPACT Guidelines
Time frame: Duration of trial (2-20 months, depending on how long pain relief lasts)
NRS Score Three Weeks After Injection
Time frame: 3 weeks after injection

Results and safety

Results posted to the registry on 15 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Then Botox	2	2
Botox Then Placebo	3	3

Primary outcome: Time to Analgesic Failure

Time frame: Duration of trial (2-20 months, depending on how long pain relief lasts). Mean (Standard Deviation). Unit: days

Measure	Placebo n = 3	Botox n = 3
Value	120.67 (166.79)	20.67 (22.72)

Population analysed: A total of 3 participants completed the study (1 received Placebo first then Botox, 2 received Botox first then Placebo). Each of those 3 participants received both Placebo and Botox, as represented in the overall number of participants analyzed for both treatments.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Then Botox	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Botox Then Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ian R Carroll principal investigator

Stanford University

Sean Mackey principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Botulinum Toxin Type A and Saline in people with Pain, run by Stanford University at 1 site in United States.

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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Aug 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Analgesic Failure (time frame: Duration of trial (2-20 months, depending on how long pain relief lasts)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00822926.

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 15 Aug 2017.