Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout

NCT01519687 | Unknown Phase 2

• 1 other identifier: PRS-TOFS-G201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.

Conditions

Hyperuricemia; Gout

Keywords

hyperuricemia; gout; levotofisopam

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in serum urate

  The primary efficacy variable is the percentage reduction in serum urate from baseline to Day 7 on treatment with levotofisopam.

  Days 1-7

Secondary Outcomes (1)

• Absolute reduction in serum urate from baseline

  Days 1-7

Study Arms (1)

Levotofisopam

EXPERIMENTAL

All patients will receive a single dose of 50 mg on Day 1, 50 mg three times a day (TID) on Days 2 through 6, and a single dose of 50 mg on Day 7. Each dose of study drug will be administered by authorized site personnel throughout the 7-day inpatient treatment period.

Drug: levotofisopam

Interventions

levotofisopam DRUG

50 mg on Day 1, 50 mg TID on Days 2 through 6, and a single dose of 50 mg on Day 7

Also known as: S-tofisopam

Levotofisopam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide voluntary, signed informed consent.
• Male or postmenopausal or surgically sterile females, 18 to 65 years of age, inclusive. Female participants must have been amenorrheic for a minimum of 12 months and must have a negative pregnancy test result within 3 days before administration of levotofisopam. Surgically sterile females are defined as those who have had a hysterectomy, bilateral ovariectomy, or bilateral tubal ligation. Male subjects must agree to practice a medically acceptable form of contraception for the duration of the study and for 30 days after receiving the last dose of levotofisopam.
• Physician diagnosis of gout with at least one gout flare in the last 6 months, at least one chronically swollen joint due to gout, or presence of a tophus.
• Serum urate level ≥ 8.0 mg/dL and ≤ 12.0 mg/dL after having stopped all urate-lowering therapy for at least 10 days. Serum urate level must also be \> 7.7 mg/dL and ≤ 12.0 mg/dL on Day -3 and on Day -2.
• Willing and able to discontinue urate-lowering therapy starting at the screening visit (14-21 days before receiving study drug) through to the follow-up visit (up to 10 days after discharge from the study unit), for a total time off urate-lowering therapy of up to approximately 5 weeks.
• In the opinion of the investigator, able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant.
• Medications permitted for the treatment of non-excluded medical conditions (other than gout) must be at stable doses for at least 14 days prior to baseline.
• Permitted concurrent general medical conditions must be stable and well controlled.
• Written and oral fluency in the English language.

You may not qualify if:

• Previous treatment with racemic tofisopam (RS-tofisopam), levotofisopam (S-tofisopam), or dextofisopam (R-tofisopam).
• Known or suspected hypersensitivity to any benzodiazepine.
• History of two or more clinically significant drug allergies.
• Clinically significant infection within 30 days prior to screening or between screen and admission.
• History or presence of clinically significant medical disease that might compromise the study or be detrimental to the patient, such as hepatitis (patient excluded if hepatitis A was present within 2 years before screening or if there is any history of hepatitis B or C), human immunodeficiency virus (HIV) infection, uncontrolled diabetes mellitus, cirrhosis, active biliary disease (bile ducts or gallbladder), or moderate or severe chronic kidney disease (estimated glomerular filtration rate \< 60 mL/min/1.73 m2).
• Presence of a gout flare during screening or the procedure window.
• History or presence of nephrolithiasis.
• History or presence of malignancy other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected within 5 years.
• Clinically significant head trauma with loss of consciousness within 10 years prior to screen.
• Myocardial infarction, congestive heart failure, or known coronary artery disease within 5 years prior to screen.
• Any history of cerebrovascular accident.
• History of seizure disorder other than a single childhood febrile seizure.
• Alcohol or psychoactive substance abuse or dependence, as defined by DSM-IV, within 1 year prior to screen, or alcohol use exceeding 21 units per week (on average) in the 3 months preceding screen.
• Used any tobacco- or nicotine-containing product more days than not within 30 days prior to screening or between screen and admission.
• Regular consumption (e.g., more days than not) of excessive quantities of caffeine-containing beverages (e.g., more than eight cups of coffee or equivalent per day) within 30 days prior to screening or between screen and admission.

Sponsors & Collaborators

• Pharmos: lead

Study Sites (1)

Duke Clinical Research Unit (DCRU)

Durham, North Carolina, 27720, United States

RECRUITING

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

tofisopam

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• John S. Sundy, MD, PhD

  Duke Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John S. Sundy, MD, PhD

CONTACT

(919) 684-2347; john.sundy@duke.edu

Lou Cappoli, MBA

CONTACT

(919) 684-4888; lou.cappoli@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 27, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 27, 2012

Record last verified: 2012-01

Locations

US (1)