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Clinical Trials

Dr. Patel - Clinical Research

At the Kansas Institute of Research, we as a team are focused on providing safe and quality care to our patients. Our research team is committed to exploring new and innovative treatments to better serve our patients, and our team is constantly looking to start new studies that may impact our patients. The Kansas Institute of Research has been conducting clinical trial for more than 13 years.

Our clinical trials are conducted within our office location, allowing our team to work closely and provides great accessibility for monitoring patients and improves the safety and quality of our research and care for our patient.

Our goal is to provide the opportunity for patients to participate in new treatments and therapies to improve patient’s function. With our research we can help bring new treatments to more patients and have a greater impact on the medical community. We are committed to growth and interested in expanding our clinical trials for our patients.

If you are interested in participating in one of our clinical trials, please see details for our current research studies below. Please contact our research team at 913-652-6475 if any of these current studies interest you.

Current Clinical Trials

PRECLUDE Episodic Migraine: Phase 3 Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects with Episodic Migraine (ENROLLMENT CLOSING SOON!)

  1. Adult male or female, 18 to 65 years old.
  2. Onset of migraine before 50 years of age.
  3. History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1.
  4. No use of any opioids or barbiturates > 2 days/month or any gepant in the 3 months prior to Visit 1 per investigator's judgment, or during the baseline or screening phase.
  5. No prior use of ANY botulinum toxin (any serotype, therapeutic or cosmetic) injections in the head, face, and/or neck in the subject's lifetime.
  6. No concurrent use or use of any migraine prophylactic treatment in the 4 weeks prior to Visit 1 nor during the baseline or screening phase.

Daily Oral Preventative for Chronic Migraine: A Phase 2/3 Randomized, Double-Blind, PlaceboControlled Study to Evaluate the Efficacy and Safety of Oral Zavegepant in Migraine Prevention

  1. Male and Female subjects ≥18 years of age.
  2. Per subject report, the occurrence of at least 15 headache days per month, at least 8 migraine days per month, and at least 1 headache-free day per month during the last 3 months prior to the Screening Visit.
  3. Subjects with a history of basilar migraine or hemiplegic migraine is exclusionary.
  4. Body mass index > 33.0 kg/m2 is exclusionary.

UNCHAINED Chronic Migraine: A Phase 3 Multicenter 24-Week Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Atogepant When Added to OnabotulinumtoxinA (BOTOX) for the Preventive Treatment of Chronic Migraine

  1. Adult male or female, between 18 and 75 years, inclusive.
  2. Participants must be currently treated with BOTOX for CM: treated with ≥ 2 treatment cycles in the 8 months prior to Visit 2 (Day 1) with documentation of payer authorization to support continued use of BOTOX. Participants should have ability to coordinate standard-of-care BOTOX injections for Visits 2, 5, and 8 (± 7 days) through their primary care physician or another prescribing healthcare provider.
  3. Previous administration of BOTOX prior to study entry was between 8 ± 1 week prior to scheduled Screening to ensure BOTOX administration at 12-week intervals and was between 155 U and 195 U divided between 31 to 39 sites across 7 specific head/neck muscle areas (not to include masseter). Participants must be able to have stability of dose and injection location paradigm during the study.
  4. No use of opioid-containing products for more than 4 days for acute treatment of headache in the 3 months prior to Screening or during the screening/baseline period.
  5. No known history of prior receipt of atogepant prior to participation in this study.

DIRECTION Upper Limb Spasticity: An Interventional, Post-marketing, Randomized, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison with OnabotulinumtoxinA (Botox®) when Treating Adults with Upper Limb Spasticity.

  1. 18–80 years of age
  2. Participants with stable ULS for at least 3 months (USA/France) or stable post-stroke ULS for at least 3 months (Canada), in whom treatment of only one upper limb is necessary for the duration of the study
  3. Participants who are either naïve to BoNT-A for ULS or who have been previously treated with BoNT-A for ULS

Eligible participants will be randomized in a 1:1 ratio to one of two study intervention sequences (282 participants per sequence). Assignment to study intervention (randomization) will be stratified based on the BoNT-A status (BoNT-A previously treated for ULS or naïve).

Sequence 1: participants will receive one cycle of aboBoNT-A (900 Units) followed by one cycle of onaBoNT-A (360 Units)

Sequence 2: participants will receive one cycle of onaBoNT-A (360 Units) followed by one cycle of aboBoNT-A (900 Units)

Long-Acting BoNT Upper Limb Spasticity: Evaluate the safety, efficacy, tolerability of ABBV-950 in post-stroke patients with upper limb spasticity; Characterize ABBV-950 dose-response relative to BOTOX regimen and identify optimal doses for future efficacy and safety studies.

  1. 18 to 80 years of age
  2. Participant has upper limb spasticity due to stroke, with most recent stroke occurring at least 12 weeks prior to the screening visit
  3. In the opinion of the investigator, the participant has sufficient spasticity to warrant a total BOTOX dose of up to 500 U divided among wrist, fingers and elbow of the same limb.

LANTIMA Upper Limb Spasticity: An Integrated Phase I/II, Multicentre, Double-Blind, Randomised, Dysport and Placebo Controlled, Dose-Escalation and Dose-Finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity.

  1. 18 to 70 years of age
  2. Has spastic hemiparesis at least 6 months post-stroke or TBI
  3. Is eligible to receive a total recommended dose 1000 U Dysport in the upper limb
  4. Has received previous treatment with phenol and or alcohol in the targeted upper limb any time before the study. (Exclusion)
  5. Has been treated or is likely to be treated with intrathecal baclofen during the 30 days prior to study Baseline or during the course of the study. (Exclusion)

ELATE Essential Tremor: A Phase 2 Multicenter, Randomized, Double-blind, Placebo controlled Study of BOTOX® for the Treatment of Upper Limb Essential Tremor

  1. Adult male or female, 18 to 80 years of age
  2. Moderate-to-severe upper-limb tremor
  3. First onset of essential tremor at least 1 year before Screening with stability of the tremor symptoms over the 4 weeks previous to Screening.
  4. Subject must have upper limb ET of sufficient severity in the dominant limb to warrant treatment with at least 60U of BOTOX in the mandatory muscles, in the investigator's opinion
  5. Subject must not have used anti-tremor medications that have not been taken at a stable dose for at least 4 weeks prior to Screening.
  6. Subject must not have had recent (16 weeks) treatment with any Botulinum toxin product for any reason. Past use of any BoNT-A product for UL ET is exclusionary

RISE Post Surgical Neuropathic Pain: An interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial evaluating the efficacy and safety of Qutenza® in subjects with post-surgical neuropathic pain.

Patients may qualify for participation in the RISE study if you healed from surgery in the past five years, and are experiencing in the surgical area:

  • Burning pain
  • Painful cold sensations
  • Electric shocks

That may be combined with feelings of:

  • Tingling
  • Pins and needles
  • Numbness
  • Itching
  1. 18 years of age or older
  2. A history of post-surgical pain with a duration of at least 6 months to maximally 60 months that is plausibly related to the surgical intervention as documented on a body map.
  3. The subject experiencing pain is:
  1. currently not receiving treatment for PSNP or
  2. receives a stable systemic treatment for PSNP that started more than 30 days prior to the Randomization Visit

Is a clinical trial for you?

Who should consider clinical trials and why?

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials.

Some people participate in clinical trials because they have exhausted standard (approved) treatment options – which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.

Other people participate in trials because they want to contribute to the advancement of medical knowledge.

For each clinical trial, researchers develop eligibility criteria, such as the age, sex, type and stage of disease, previous treatment history, and other medical conditions. These criteria help to reduce the amount of variation in the study, without threatening the scientific integrity of the trial, by removing medical variations that might complicate analyzing the results.

Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.