STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Ch… (NCT05603702) | Clinical Trial Compass
RecruitingPhase 1
STTEPP: Safety, Tolerability and Dose Limiting Toxicity of Lacosamide in Patients With Painful Chronic Pancreatitis
United States24 participantsStarted 2023-03-17
Plain-language summary
The investigators propose to conduct a dose-escalation trial of an FDA-approved antiepileptic drug, lacosamide, added to opioid therapy in patients with chronic abdominal pain from chronic pancreatitis (CP). This pilot trial will test the feasibility of the study design and provide reassurance regarding the tolerability and safety of lacosamide used concomitantly with opioids in this patient population to reduce the condition known clinically as opioid-induced hyperalgesia (OIH).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. written informed consent and HIPAA authorization for release of personal health information;
✓. ≥ 18 years old at the time of informed consent;
✓. suspected (YELLOW 2 or 3) or definite diagnosis of CP, as per CPDPC PROCEED study definition with ongoing symptoms of abdominal pain;
✓. patients must be maintained on an opioid (except methadone or suboxone) for 4 weeks prior to enrollment for treatment of abdominal pain related to pancreatitis;
✓. ongoing symptoms of abdominal pain even with opioid use (VAS and BPI average score ≥4, at enrollment);
✓. ECOG Performance Status of 0-2;(Oken et al., 1982)
✓. ability to swallow and tolerate oral tablets;
✓. females of childbearing potential must have a negative pregnancy test;
Exclusion criteria
✕. subjects with indeterminate CP (YELLOW 1) as per PROCEED criteria;
What they're measuring
1
Dose-limiting toxicity of lacosamide in combination with opioids in CP patients will be measured by the number of grade 3 or4 toxicities reported via the CTCAE v5.0, between Day 1 through 21 day follow up.
Timeframe: Day 1, 21 day follow up
2
Tolerability of lacosamide in combination with opioids in CP patients will be evaluated by the percentage of compliance in taking lacosamide pills as directed between Day 1 and Day 7.
Timeframe: Day 1, Day 7
3
Feasibility of performance of a pilot study adding lacosamide to opioid therapy in CP patients based on recruitment rate: measured by the proportion of eligible patients who continue from the screening visit to the enrollment visit.
Timeframe: Screening visit, Enrollment visit
4
Feasibility of performance of a pilot study adding lacosamide to opioid therapy in CP patients based on retention rate measured by the change from the screening visit to the 21 day follow-up visit.
. treatment with any investigational agent within 30 days prior to registration, or concurrent participation in a clinical trial which involves another investigational agent;
✕. rapidly escalating pain that requires parenteral (intravenous or intramuscular) opioid therapy within 30 days of enrollment;
✕. known hypersensitivity/allergic reaction to lacosamide, carbamazepine or oxcarbazepine;
✕. pregnant or breastfeeding;
✕. patient who has a diagnosis of epilepsy and/or is currently taking anti-epileptic drugs (other than gabapentin and pregabalin);
✕. abdominal surgery or pain intervention (ERCP with sphincterotomy/stent/stone removal; celiac plexus block) within 90 days of enrollment.
✕. hospitalization for pancreatitis exacerbation or pain management within 30 days of enrollment