Aneurysmal Subarachnoid HemorrhagePhase 4NCT02330094
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
A Phase 4 study testing Gabapentin in people with Aneurysmal Subarachnoid Hemorrhage, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 1 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction angiogram or MRA)
- Have symptomatic headache
- Able to swallow and verbalize pain score
- No known allergy to gabapentin or fentanyl
- Numeric pain score ≥ 5
- Ability to provide written personal consent
Who cannot join
- Gabapentin use prior to SAH admission
- Renal failure with creatinine clearance less than 30 mL/min
- Unable to receive standard of care pain medications
- Pregnant or breastfeeding patients
- History of severe depression defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.
Read the detailed description
The investigators plan to use gabapentin (GBP), an FDA approved non-narcotic pain medication for neuropathic pain, which is also an alpha-2-delta (A2DR) receptor analogue to reduce the pain and decrease the need for narcotics in patients with aneurysmal subarachnoid hemorrhage (aSAH). GBP has been shown to decrease neuropathic and non-neuropathic pain in a variety of perioperative and postoperative conditions. A2DR affinity also has some neuroprotective effect in animal data. The investigators plan to conduct a prospective, double-blinded, randomized trial to further assess GBP-associated reductions in narcotic use and pain scores compared to the non-GBP (placebo) arm. To accomplish this aim, the investigators plan to randomize 20 aSAH patients with headache to either GBP and standard of care pain treatment versus placebo and standard of care treatment.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Gabapentin, Placebo
- Keywords
- aSAH, SAH
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
PlaceboDrug
Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
Both groups will receive other standard of care pain medications.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Gabapentin capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID. Receives: Drug: Gabapentin |
| Control | Placebo comparator | Placebo capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Numeric Pain Score
Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score.
Measured: baseline through day 7
Average Narcotic Consumption
The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME).
Measured: baseline through day 7
Secondary outcomes (1)
Pain Control Satisfaction Questionnaire
The Brigham and Women's Hospital Management of Post-operative Pain Patients discharge questionnaire (BWQ) was used to measure pain control satisfaction. The questionnaire was modified and transformed into a uniform scale so all numbers were on the same direction. Subjects were asked to answer six questions on a score of 0-5, for a total possible range of 0-30. A lower score indicated a better outcome (less pain) and higher pain control satisfaction and a higher score indicated a worse outcome (more pain) and lower pain control satisfaction.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William D. Freeman, Mayo Clinic
- Investigators
- William Freeman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330094
- Sponsor's protocol ID
- 14-005288
- Status last verified
- Aug 2019
- First submitted
- 24 Dec 2014
- Last updated
- 10 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dhakal LP, Turnbull MT, Jackson DA, Edwards E, Hodge DO, Thottempudi N, Kamireddi P, Akinduro OO, Miller DA, Meschia JF, Freeman WD. Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study. Front Neurol. 2020 Jul 28;11:744. doi: 10.3389/fneur.2020.00744. eCollection 2020.
PubMed 32849209
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02330094
- Acronym / sponsor ID
- 14-005288
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- aSAH, SAH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 1 Jan 2015 (estimated)
- Results
- Posted 10 Sep 2019
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 see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.
Detailed description
The investigators plan to use gabapentin (GBP), an FDA approved non-narcotic pain medication for neuropathic pain, which is also an alpha-2-delta (A2DR) receptor analogue to reduce the pain and decrease the need for narcotics in patients with aneurysmal subarachnoid hemorrhage (aSAH). GBP has been shown to decrease neuropathic and non-neuropathic pain in a variety of perioperative and postoperative conditions. A2DR affinity also has some neuroprotective effect in animal data. The investigators plan to conduct a prospective, double-blinded, randomized trial to further assess GBP-associated reductions in narcotic use and pain scores compared to the non-GBP (placebo) arm. To accomplish this aim, the investigators plan to randomize 20 aSAH patients with headache to either GBP and standard of care pain treatment versus placebo and standard of care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinGabapentin capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID. |
| Control | Placebo comparator | Drug: PlaceboPlacebo capsules 100 mg ter in die (TID), 200 mg TID, 300 mg TID, 400 mg TID, 600 mg TID, 900 mg TID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction angiogram or MRA)
- Have symptomatic headache
- Able to swallow and verbalize pain score
- No known allergy to gabapentin or fentanyl
Key exclusion criteria (5 listed)
- Gabapentin use prior to SAH admission
- Renal failure with creatinine clearance less than 30 mL/min
- Unable to receive standard of care pain medications
- Pregnant or breastfeeding patients
- History of severe depression defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV)
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 |
|---|---|---|
| GabapentinAlso: NeurontinGabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance. Both groups will receive other standard of care pain medications. | Drug | Gabapentin |
| PlaceboPlacebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance. Both groups will receive other standard of care pain medications. | Drug | Control |
Primary outcome
Average Numeric Pain Score
Time frame: baseline through day 7
Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score.
Average Narcotic Consumption
Time frame: baseline through day 7
The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME).
1 secondary outcome
Pain Control Satisfaction Questionnaire
Time frame: Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32849209Dhakal LP, Turnbull MT, Jackson DA, Edwards E, Hodge DO, Thottempudi N, Kamireddi P, Akinduro OO, Miller DA, Meschia JF, Freeman WD. Safety, Tolerability, and Efficacy of Pain Reduction by Gabapentin for Acute Headache and Meningismus After Aneurysmal Subarachnoid Hemorrhage: A Pilot Study. Front Neurol. 2020 Jul 28;11:744. doi: 10.3389/fneur.2020.00744. eCollection 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
William Freeman, MD principal investigator
Mayo Clinic
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 Gabapentin in people with Aneurysmal Subarachnoid Hemorrhage, run by Mayo Clinic 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 7 inclusion and 5 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 10 Sep 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. 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?
Yes. Results are posted in the registry (first posted 10 Sep 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?
Average Numeric Pain Score (time frame: baseline through day 7). 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?
On the ClinicalTrials.gov record for NCT02330094, which also lists 1 linked publication.
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 10 Sep 2019.