Neuropathic Pain Due to Spinal Cord InjuryPhase 2NCT01748695
A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
A Phase 2 study testing V158866 in people with Neuropathic Pain Due to Spinal Cord Injury, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathic Pain Due to Spinal Cord Injury
- What is being tested?
- V158866
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2015
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 - 65 years
- documented spinal cord injury at or below T5
- moderate pain at or below the level of the spinal cord injury for at least 3 months
- compliant with daily diary
- stable pain scores on the NRS
- mean pain intensity of at least 4 and not more than 9 on the NRS (or if the mean NRS score is >9, the mean Gracely score must be ≤19)
Who cannot join
- women of child-bearing potential
- men who intend to father a child
- a history of multiple drug allergies, hypersensitivity to any cannabinoid
- an increased risk of seizure
- evidence of depression and/or a score of >19 on the BDI-II
- suicidal ideation or suicidal behavior in the past 10 years
Show all 10Show fewer
- a history of substance abuse or dependence within the past year, excluding nicotine and caffeine
- a positive urine test for cannabis at screening
- taking excluded medications that cannot be stopped
- a positive pregnancy test
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Pain Research, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Phase IIa, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study Evaluating the Safety, Tolerability and Efficacy of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury.
- Being tested
- V158866, Placebo
- Keywords
- Neuropathic pain, Spinal cord injury
- Medical subject headings
- Neuralgia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V158866Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo followed by V158866 | Experimental | Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks Receives: Drug: V158866; Drug: Placebo |
| V158866 followed by Placebo | Experimental | V158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks Receives: Drug: V158866; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Intensity (NRS)
Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).
Measured: 4 Weeks
Safety and Tolerability of V158866 Compared to Placebo
Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJun 2013
- Primary completionJul 2015
- Study completionJul 2015
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 Neuropathic Pain Due to Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vernalis (R&D) Ltd
- Responsible party
- Principal investigator, Christine N. Sang, MD, MPH, Brigham and Women's Hospital
- Investigators
- Christine N Sang, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748695
- Sponsor's protocol ID
- V158866-2Pa-01
- Status last verified
- Apr 2017
- First submitted
- 11 Dec 2012
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over Study Evaluating the Safety, Tolerability and Efficacy of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01748695
- Acronym / sponsor ID
- V158866-2Pa-01
- Keywords
- Neuropathic pain, Spinal cord injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Vernalis (R&D) Ltd
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether V158866 is safe and effective for the treatment of neuropathic pain due to spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo followed by V158866 | Experimental | Drug: V158866, Drug: PlaceboPlacebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks |
| V158866 followed by Placebo | Experimental | Drug: V158866, Drug: PlaceboV158866 450mg once per day for 4 Weeks followed by Placebo once per day for 4 Weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18 - 65 years
- documented spinal cord injury at or below T5
- moderate pain at or below the level of the spinal cord injury for at least 3 months
- compliant with daily diary
- stable pain scores on the NRS
Key exclusion criteria (10 listed)
- women of child-bearing potential
- men who intend to father a child
- a history of multiple drug allergies, hypersensitivity to any cannabinoid
- an increased risk of seizure
- evidence of depression and/or a score of >19 on the BDI-II
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 |
|---|---|---|
| V158866 | Drug | Placebo followed by V158866, V158866 followed by Placebo |
| Placebo | Drug | Placebo followed by V158866, V158866 followed by Placebo |
Primary outcome
Mean Pain Intensity (NRS)
Time frame: 4 Weeks
Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).
Safety and Tolerability of V158866 Compared to Placebo
Time frame: 4 weeks
Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Neuropathic Pain Due to Spinal Cord Injury
Recruiting
Virtual Walking to Reduce Chronic Neuropathic Pain in Subjects With SCI
Spinal Cord Injuries (SCI), Neuropathic Pain Due to Spinal Cord Injury
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.
Christine N Sang, MD, MPH principal investigator
Brigham and Women's Hospital
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 V158866 in people with Neuropathic Pain Due to Spinal Cord Injury, run by Brigham and Women's Hospital 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 10 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 11 Apr 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.
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?
Yes. Results are posted in the registry (first posted 11 Apr 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?
Mean Pain Intensity (NRS) (time frame: 4 Weeks). The study lists 2 primary outcomes in all. 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 11 Apr 2017.