Weight LossEarly Phase 1NCT04613024
Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty
A Early Phase 1 study testing Topamax and Gabapentin in people with Weight Loss and Pain, Postoperative, run by Stanford University at 1 site in United States Minor Outlying Islands.
Trial summary
The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Weight Loss, Pain, Postoperative
- What is being tested?
- Topamax and Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States Minor Outlying Islands
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Early Phase 1
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient will be eligible for the study if they are scheduled for a primary TKA or THA with a BMI >30 and <40 kg/m2, or >40 kg/m2
- Patients refusing bariatric surgery or having had prior bariatric surgery
Who cannot join
- Patients will be ineligible to participate if they have any of the following:
- known topiramate or gabapentin allergy
- history of seizure disorder
- chronic opiate use pre-operatively
- history of nephrolithiasis
- history of acute angle closure glaucoma
Show all 15Show fewer
- recurrent major depression
- presence or history of suicidal behavior or ideation with intent to act
- current substantial depressive symptoms (Patient Health Questionnaire total score >10), pregnancy
- child-bearing potential and not on contraception
- age <18 years
- major neurocognitive disorder
- metabolic acidosis
- incarcerated status
- bilateral surgery
Trial locations and contacts
1 site in 1 country.
United States Minor Outlying Islands1 site
Stanford University
Palo Alto
About this study
Official title: Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction
The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery
Read the detailed description
Investigator hypothesize that low dose peri-operative topiramate is superior to gabapentin in reducing postoperative pain and opioid consumption after primary TJA with a more favorable side effect profile that will facilitate patient optimization via pre- and postoperative weight loss.
- Conditions
- Weight Loss, Pain, Postoperative
- Being tested
- Topamax, Gabapentin
- Medical subject headings
- Weight Loss, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopamaxDrug
Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval
GabapentinDrug
Control group will be prescribed gabapentin after surgery with follow up at regular interval
| Study group | Role | What they receive |
|---|---|---|
| Experiment | Experimental | Topamax randomized group Receives: Drug: Topamax |
| Control | Active comparator | Gabapentin randomized group Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the reduction in Opioid Consumption
Postoperative morphine equivalent opiate use and opiate refill requests after discharge will be compared post randomization to receive one of the two medications for multimodal pain control.
Measured: 3 months
Evaluate the Side Effect Profiles of Topiramate
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
Measured: 3 months
Evaluate the Side Effect Profiles of gabapentin
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
Measured: 3 months
Secondary outcomes (12)
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin
Harris hip score will be calculated after randomization at the pre-operative visit. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 1 week
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
Harris hip score will be calculated after surgery. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 2 week
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
Harris hip score will be calculated after surgery. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 6week
Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Harris hip score will be calculated after surgery. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Measured: 3 months
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
SF12 will be calculated after surgery
Measured: 3 months
SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks
SF12 will be calculated after surgery
Measured: 2 week
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
SF12 will be calculated after surgery
Measured: 6 week
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week
SF12 will be calculated after surgery
Measured: 1 week
WOMAC score Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores
Measured: 6 week
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores
Measured: 2 week
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores
Measured: 3 months
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
WOMAC score will be calculated after surgery. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start1 Jul 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jul 2027 (estimated)
Why it stopped: Not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derek Amanatullah, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613024
- Sponsor's protocol ID
- 56915
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2020
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction
- ClinicalTrials.gov ID
- NCT04613024
- Acronym / sponsor ID
- 56915
- Conditions
- Weight Loss, Pain, Postoperative
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 3 Nov 2020 (actual)
- 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.
The purpose of this study is to evaluate the effects of topiramate (TPM) in obese patients with respect to weight loss and pain after total joint replacement surgery
Detailed description
Investigator hypothesize that low dose peri-operative topiramate is superior to gabapentin in reducing postoperative pain and opioid consumption after primary TJA with a more favorable side effect profile that will facilitate patient optimization via pre- and postoperative weight loss.
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 |
|---|---|---|
| Experiment | Experimental | Drug: TopamaxTopamax randomized group |
| Control | Active comparator | Drug: GabapentinGabapentin randomized group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient will be eligible for the study if they are scheduled for a primary TKA or THA with a BMI >30 and <40 kg/m2, or >40 kg/m2
- Patients refusing bariatric surgery or having had prior bariatric surgery
Key exclusion criteria (15 listed)
- Patients will be ineligible to participate if they have any of the following:
- known topiramate or gabapentin allergy
- history of seizure disorder
- chronic opiate use pre-operatively
- history of nephrolithiasis
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 |
|---|---|---|
| TopamaxExperiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval | Drug | Experiment |
| GabapentinControl group will be prescribed gabapentin after surgery with follow up at regular interval | Drug | Control |
Primary outcome
Determine the reduction in Opioid Consumption
Time frame: 3 months
Postoperative morphine equivalent opiate use and opiate refill requests after discharge will be compared post randomization to receive one of the two medications for multimodal pain control.
Evaluate the Side Effect Profiles of Topiramate
Time frame: 3 months
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
Evaluate the Side Effect Profiles of gabapentin
Time frame: 3 months
Perioperative weight change experienced by patients will be compared after randomization to receive one of the two medications. Weight change is measured in lbs
12 secondary outcomes
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin
Time frame: 1 week
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
Time frame: 2 week
Harris hip score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
Time frame: 6week
Harris hip score -Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Time frame: 3 months
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Time frame: 3 months
SF12 Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2weeks
Time frame: 2 week
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
Time frame: 6 week
SF12- Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 1 week
Time frame: 1 week
WOMAC score Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 6 weeks
Time frame: 6 week
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 2 weeks
Time frame: 2 week
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Time frame: 3 months
WOMAC score - Evaluate Short-term Arthroplasty-related Outcomes and Complications while on Topiramate or Gabapentin at 3 months
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Topamax and Gabapentin in people with Weight Loss and Pain, Postoperative, run by Stanford University at 1 site in United States Minor Outlying Islands.
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 2 inclusion and 15 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: withdrawn, as of the sponsor's last update on 11 Apr 2025. 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 Minor Outlying Islands. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 withdrawn before enrolling participants, so there are no results.
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?
Determine the reduction in Opioid Consumption (time frame: 3 months). The study lists 3 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 2025.