Neuropathic PainPhase 2NCT01911377
Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS
A Phase 2 study testing Botulinum Toxin Type A and Normal Saline for Injection in people with Neuropathic Pain and Allodynia, run by University of Manitoba at 1 site in Canada.
Trial summary
This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis. Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain, Allodynia
- What is being tested?
- Botulinum Toxin Type A and Normal Saline for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Aug 2015
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfills the criteria for neuropathic pain causing allodynia according to IASP pain terminology.
- Allodynia that is resistant to, or has failed, the standard level of care measures for more that six months.
- Allodynia pain on a daily basis.
- Allodynia pain that scores at least 4/10 on a pain numerical scale.
- Other pain medications(including antidepressants and anticonvulsants)have been maintained at a stable dose for at least 2 months prior to enrollment.
- Ability to communicate in English.
Who cannot join
- Presence of other pain syndromes (e.g.,fibromyalgia, ongoing peripheral neuropathic pain.
- Allergy to Botulinum Toxin Type A.
- Allergy to albumin.
- Use of Botulinum Toxin Type A for other treatment indications in the 3 months prior to enrollment.
- Renal failure.
- Hepatic failure.
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- Neuromuscular junction disorders.
- Bleeding diathesis.
- Cognitive impairment, dementia, major depression or psychotic disorder.
- Pregnant or breastfeeding.
- Infection at the injection site.
- Active alchohol or substance abuse.
Trial locations and contacts
1 site in 1 country.
Canada1 site
WRHA Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, R3A IM4
About this study
Official title: The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis
This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis.
Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or people with multiple sclerosis.
Read more
Allodynia is a type of neuropathic pain caused by something that normally would not cause pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.
Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has recently been studied as a treatment for neuropathic pain.
We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type neuropathic pain.
24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 "controls" receiving placebo.
- Conditions
- Neuropathic Pain, Allodynia
- Being tested
- Botulinum Toxin Type A, Normal Saline for Injection
- Medical subject headings
- Neuralgia, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ADrug
Normal Saline for InjectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Botulinum Toxin Type A | Active comparator | 200 units of Botulinum Toxin Type a will be administered intradermally to the allodynic area chosen for study.The allodynic area will be mapped, and the number of injections needed to cover the allodynic area without exceeding 40 injection sites will be determined.
All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any discomfort caused by the injections. Receives: Drug: Botulinum Toxin Type A |
| Arm 2: Normal Saline for Injection | Placebo comparator | Normal saline for intradermal injection will be prepared by the Investigational Pharmacy in a manner as to be indistinguishable from active drug. The allodynic area will be mapped so as to determine the number of injections needed to cover the whole allodynic area without exceeding 40 injection sites. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any pain caused by the injections. Receives: Drug: Normal Saline for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Pain Inventory
The primary outcome measure will be the self-reported average pain intensity from each morning's record in a diary. The average(self-reported) pain intensity will be measured at the screening visit, then the daily diary will be dispensed. The diary will ask for the average pain intensity of the last 24 hours using an 11-point numerical scale, with 0 representing no pain and 10 representing the worst pain imaginable
Measured: Baseline and daily until study completion at 13 weeks
Secondary outcomes (5)
Neuropathic Pain Symptom Inventory
This scale rates the mean intensity of 10 neuropathic pain symptoms and their combination into 5 distinct dimensions during the last 24 hours on an 11-point (0-10) numerical scale
Measured: Baseline and follow-up visits(at weeks 1, 4, 8 and 13)
The Hospital Anxiety and Depression Scale
14 items scored as anxiety and depression
Measured: Baseline and follow-up visits (at weeks 1, 4, 8 and 13).
Daily Sleep Interference Scale
Asks if pain interfered with sleep in the past 24 hours,using an 11-point scale (O-pain did not interfere with sleep, 10-pain completely interfered with sleep).
Dispensed at baseline.
Measured: Baseline and daily during study period until week 13.
Clinician Global Impression Scale
Assesses the clinician's impression of Efficacy and Tolerability of study medication using a 4-point scale, with 1 being Very good, and 4 being Poor
Measured: Final visit at week 13
Patient's Global Impression Scale
Measures the patients global impression of the efficacy and tolerability of the study medication on a 4-point scale, with 1 representing very good, and 4 representing poor
Measured: Final visit at week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionAug 2015
Why it stopped: 12 SCI volunteers completed the study. As the data analysis was negative, the decision was made not to proceed with MS recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Dr. Karen Ethans, University of Manitoba
- Investigators
- Karen Ethans, MD, Principal investigator, Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911377
- Sponsor's protocol ID
- Botox 2013
- Status last verified
- Oct 2015
- First submitted
- 25 Jul 2013
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Botulinum Toxin Type A in the Treatment of Allodynic-Type Neuropathic Pain in People With Spinal Cord Injury or Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01911377
- Acronym / sponsor ID
- Botox 2013
- Conditions
- Neuropathic Pain, Allodynia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 12 SCI volunteers completed the study. As the data analysis was negative, the decision was made not to proceed with MS recruitment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jul 2013 (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.
This study will examine the efficacy of Botulinum Toxin Type A ("Botox") in treating Allodynic-type neuropathic pain in people with spinal cord injury or multiple sclerosis.
Neuropathic pain is pain initiated or caused by injury to or disease of the nervous system, and is common in spinal cord injury patients or people with multiple sclerosis.
Allodynia is a type of neuropathic pain caused by something that normally would not cause pain, such as light touch, pressure from clothing, or bed sheets brushing against the skin.
Botox has been used to treat the muscle overactivity that causes spasticity in spinal cord injured patients. It has been noticed to exert some analgesic(pain relieving) effect, and has recently been studied as a treatment for neuropathic pain.
We want to see if Botox, injected intradermally, will relieve the symptoms of allodynic-type neuropathic pain.
24 volunteers are to be enrolled, with 16 receiving active treatment, and 8 "controls" receiving placebo.
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 |
|---|---|---|
| Arm 1: Botulinum Toxin Type A | Active comparator | Drug: Botulinum Toxin Type A200 units of Botulinum Toxin Type a will be administered intradermally to the allodynic area chosen for study.The allodynic area will be mapped, and the number of injections needed to cover the allodynic area without exceeding 40 injection sites will be determined. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any discomfort caused by the injections. |
| Arm 2: Normal Saline for Injection | Placebo comparator | Drug: Normal Saline for InjectionNormal saline for intradermal injection will be prepared by the Investigational Pharmacy in a manner as to be indistinguishable from active drug. The allodynic area will be mapped so as to determine the number of injections needed to cover the whole allodynic area without exceeding 40 injection sites. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any pain caused by the injections. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fulfills the criteria for neuropathic pain causing allodynia according to IASP pain terminology.
- Allodynia that is resistant to, or has failed, the standard level of care measures for more that six months.
- Allodynia pain on a daily basis.
- Allodynia pain that scores at least 4/10 on a pain numerical scale.
- Other pain medications(including antidepressants and anticonvulsants)have been maintained at a stable dose for at least 2 months prior to enrollment.
Key exclusion criteria (12 listed)
- Presence of other pain syndromes (e.g.,fibromyalgia, ongoing peripheral neuropathic pain.
- Allergy to Botulinum Toxin Type A.
- Allergy to albumin.
- Use of Botulinum Toxin Type A for other treatment indications in the 3 months prior to enrollment.
- Renal failure.
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 A | Drug | Arm 1: Botulinum Toxin Type A |
| Normal Saline for Injection | Drug | Arm 2: Normal Saline for Injection |
Primary outcome
Brief Pain Inventory
Time frame: Baseline and daily until study completion at 13 weeks
The primary outcome measure will be the self-reported average pain intensity from each morning's record in a diary. The average(self-reported) pain intensity will be measured at the screening visit, then the daily diary will be dispensed. The diary will ask for the average pain intensity of the last 24 hours using an 11-point numerical scale, with 0 representing no pain and 10 representing the worst pain imaginable
5 secondary outcomes
Neuropathic Pain Symptom Inventory
Time frame: Baseline and follow-up visits(at weeks 1, 4, 8 and 13)
The Hospital Anxiety and Depression Scale
Time frame: Baseline and follow-up visits (at weeks 1, 4, 8 and 13).
Daily Sleep Interference Scale
Time frame: Baseline and daily during study period until week 13.
Clinician Global Impression Scale
Time frame: Final visit at week 13
Patient's Global Impression Scale
Time frame: Final visit at week 13
Results and safety
The study was stopped early (reason given: 12 SCI volunteers completed the study. As the data analysis was negative, the decision was made not to proceed with MS recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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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.
Karen Ethans, MD principal investigator
Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A and Normal Saline for Injection in people with Neuropathic Pain and Allodynia, run by University of Manitoba at 1 site in Canada.
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 12 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 2 Oct 2015. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: 12 SCI volunteers completed the study. As the data analysis was negative, the decision was made not to proceed with MS recruitment.). Results are not available in the source record.
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?
Brief Pain Inventory (time frame: Baseline and daily until study completion at 13 weeks). 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 2 Oct 2015.