Post-laminectomy Pain SyndromePhase 4GRASSPNCT01764464
GRASSP: Gralise® for Spine Surgery Pain
A Phase 4 study testing Gralise® in people with Post-laminectomy Pain Syndrome, run by University of Rochester at 1 site in United States.
Trial summary
Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-laminectomy Pain Syndrome
- What is being tested?
- Gralise®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Apr 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects age 18 to 80 years.
- Primary diagnosis of post-laminectomy pain syndrome (PLPS), defined as having their most severe pain related to a prior history of lumbar surgery including decompressive (e.g. laminectomy) or fusion (e.g. posterior lumbar interbody fusion) procedures performed from the L1-S1 level at least 6 months prior to enrollment.
- Pain Detect score ≥12, denoting neuropathic pain is probable.
- At least 50% of present pain intensity is attributed to the lower extremity (Quebec Task Force Grade 3 or 4) on most days.
- All subjects must be decisionally capable and must give their own consent to be enrolled.
Who cannot join
- Lumbar surgery <6 months prior to enrollment
- Subjects with PLPS and pain free interval (defined as chronic low back pain and radicular symptoms <=3/10) related the indication for their PLPS defining event and a new, acute or subacute symptom pattern (e.g. new disc herniation at an adjacent level as documented by imaging).
- Subjects regularly taking gabapentin or pregabalin for their chronic pain after spine surgery who do not endorse relief (defined as either minimally, much or very much improved on a 7 point likert scale when asked about these medications' effects).
- Having another type of pain that is as or more severe than pain associated with PLPS.
- An average daily pain score of 10 on the NRS scale during either the screening or initial washout period.
- Concurrent medication that includes antiepileptic drugs (AEDs) (exceptions: pregabalin or gabapentin).
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- Subjects taking concomitant neuropathic pain medication (stable dose for at least 4 weeks) may reduce the number and/or dose of their current pain medications: If the number and/or dose exceed the limits of allowed neuropathic pain medications (refer to Use of Allowed Pain Medication), then the number and/or dose must be reduced to fall within acceptable limits. Concomitant neuropathic pain medication needs to be kept stable during the study.
- Subjects who have previously not responded to treatment with gabapentin at doses of ≥900 mg/day or pregabalin at doses ≥300 mg/day.
- Known hypersensitivity to Gralise, or gabapentin, or its ingredients.
- Dose limiting adverse events to gabapentin; subjects who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose.
- History of alcohol and/or drug abuse in the investigator's judgment, based on subject history and physical examination.
- Subject who consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [10 ounces], wine [4 ounces], or distilled spirits [1 ounce]) per day on a regular basis.
- Participation in a clinical trial of an investigational drug or device within 30 days of the screening visit.
- Gastric reduction surgery.
- Acute gastrointestinal symptoms such as diarrhea, dyspepsia, or gastric or duodenal ulcers.
- Malignancy within past 2 years other than basal cell carcinoma.
- Women who are pregnant or breastfeeding.
- History of seizure or is at risk of seizure due to head trauma.
- History of significant cardiovascular, respiratory, endocrine, liver or kidney disease (subjects with renal impairment or creatine clearance <30 ml/min).
- Any significant medical condition, laboratory abnormality, or psychiatric illness (e.g. depression, mood problems, suicidal thoughts) that would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gralise® for Spine Surgery Pain (GRASSP): A Partially Enriched, Placebo Controlled, Randomized, Double Blind, Cross-Over Trial of Gralise® for the Treatment of Post Laminectomy Pain Syndrome
Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)
- Conditions
- Post-laminectomy Pain Syndrome
- Being tested
- Gralise®, Placebo
- Keywords
- post laminectomy pain syndrome, failed back surgery syndrome
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gralise®Drug
Also called Gralise: Gabapentin ER
14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
PlaceboDrug
Also called Placebo: inactive pill manufactured to mimic gralise.
14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). Receives: Drug: Gralise®; Drug: Placebo |
| Group B | Other | 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). Receives: Drug: Gralise®; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Numeric Rating Scale (NRS)
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).
Measured: baseline to 6 weeks
Secondary outcomes (5)
Mean Change in Visual Analog Scale (VAS)
The VAS asks subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
Measured: baseline to 6 weeks
Mean Change in Patient Global Assessment (PGA)
Subjects will be asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA is measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
Measured: baseline to 6 weeks
Mean McGill Pain Questionnaire-2 (MPQ-2)
The McGill Pain questionnaire is 22 questions where patient rate their pain symptoms with each question scaled 0-10 for a total 220 points where a higher score indicates worse outcome.
Measured: 6 weeks
Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). The scale ranges from 0 to 70. Higher scores indicate worse outcome.
Measured: baseline to 6 weeks
Insomnia Severity Index (ISI)
The ISI has 7 questions with each question ranging from 0-4 for a total of 28 points with higher scores indicating more severe insomnia.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2016
- Study completionApr 2016
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 Post-laminectomy Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Markman, University of Rochester
- Investigators
- John Markman, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764464
- Sponsor's protocol ID
- RSRB00041904
- Acronym
- GRASSP
- Status last verified
- Jul 2019
- First submitted
- 7 Jan 2013
- Last updated
- 30 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gralise® for Spine Surgery Pain (GRASSP): A Partially Enriched, Placebo Controlled, Randomized, Double Blind, Cross-Over Trial of Gralise® for the Treatment of Post Laminectomy Pain Syndrome
- ClinicalTrials.gov ID
- NCT01764464
- Acronym / sponsor ID
- GRASSP / RSRB00041904
- Conditions
- Post-laminectomy Pain Syndrome
- Keywords
- post laminectomy pain syndrome, failed back surgery syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Posted 30 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Gralise®, Drug: Placebo14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). |
| Group B | Other | Drug: Gralise®, Drug: Placebo14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). 10 day washout (no intervention). 14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female subjects age 18 to 80 years.
- Primary diagnosis of post-laminectomy pain syndrome (PLPS), defined as having their most severe pain related to a prior history of lumbar surgery including decompressive (e.g. laminectomy) or fusion (e.g. posterior lumbar interbody fusion) procedures performed from the L1-S1 level at least 6 months prior to enrollment.
- Pain Detect score ≥12, denoting neuropathic pain is probable.
- At least 50% of present pain intensity is attributed to the lower extremity (Quebec Task Force Grade 3 or 4) on most days.
- All subjects must be decisionally capable and must give their own consent to be enrolled.
Key exclusion criteria (20 listed)
- Lumbar surgery <6 months prior to enrollment
- Subjects with PLPS and pain free interval (defined as chronic low back pain and radicular symptoms <=3/10) related the indication for their PLPS defining event and a new, acute or subacute symptom pattern (e.g. new disc herniation at an adjacent level as documented by imaging).
- Subjects regularly taking gabapentin or pregabalin for their chronic pain after spine surgery who do not endorse relief (defined as either minimally, much or very much improved on a 7 point likert scale when asked about these medications' effects).
- Having another type of pain that is as or more severe than pain associated with PLPS.
- An average daily pain score of 10 on the NRS scale during either the screening or initial washout period.
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 |
|---|---|---|
| Gralise®Also: Gralise: Gabapentin ER14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®). | Drug | Group A, Group B |
| PlaceboAlso: Placebo: inactive pill manufactured to mimic gralise.14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo). | Drug | Group A, Group B |
Primary outcome
Mean Change in Numeric Rating Scale (NRS)
Time frame: baseline to 6 weeks
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable).
5 secondary outcomes
Mean Change in Visual Analog Scale (VAS)
Time frame: baseline to 6 weeks
Mean Change in Patient Global Assessment (PGA)
Time frame: baseline to 6 weeks
Mean McGill Pain Questionnaire-2 (MPQ-2)
Time frame: 6 weeks
Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)
Time frame: baseline to 6 weeks
Insomnia Severity Index (ISI)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- 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.
John Markman, MD principal investigator
University of Rochester
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 Gralise® in people with Post-laminectomy Pain Syndrome, run by University of Rochester 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 5 inclusion and 20 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 30 Jul 2019. 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 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?
Yes. Results are posted in the registry (first posted 30 Jul 2019). 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 Change in Numeric Rating Scale (NRS) (time frame: baseline to 6 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 30 Jul 2019.