A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Vince & Associates Clinical Research, Inc.
Sponsor:
Collaborator:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Vince & Associates Clinical Research, Inc.
ClinicalTrials.gov Identifier:
NCT01898676
First received: June 17, 2013
Last updated: July 9, 2013
Last verified: June 2013
  Purpose

A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.


Condition Intervention Phase
Epilepsy
Drug: Divalproex Sodium Extended-release 250mg
Drug: DEPAKOTE 250mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: An Open Label, Randomized, Four-period, Two-sequence, Fully Replicated, Single-dose, Crossover Study of the Relative Bioavailability of Two Formulations of Extended-release Divalproex Sodium Tablets in Fed Patients With Stable Epilepsy.

Resource links provided by NLM:


Further study details as provided by Vince & Associates Clinical Research, Inc.:

Primary Outcome Measures:
  • Evaluate generic divalproex sodium extended release to Depakote ER [ Time Frame: Approximately 2.5 months ] [ Designated as safety issue: No ]
    This is an open-label, randomized, two-sequence, two-treatment, single dose, four-period, fully replicated crossover study in which 16 subjects will receive one of the two study drugs, Depakote ER or a generic equivalent, during each treatment period. Subjects will be patients with epilepsy who are otherwise healthy and who are stable on anti-epileptic therapy, not including any formulation of divalproex sodium.


Estimated Enrollment: 16
Study Start Date: July 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Divalproex Sodium Extended Release 250mg
Treatment A: A single 2-tablet dose of divalproex sodium extended-release tablet, 250mg. Each subject will have 2 treatments with this medication and two treatments with a single 2-tablet dose of DEPAKOTE 250mg tablet.
Drug: Divalproex Sodium Extended-release 250mg
Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods
Other Name: DEPAKOTE 250mg
Drug: DEPAKOTE 250mg
Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.
Other Name: Divalproex Sodium Extended-Release 250mg
Active Comparator: DEPAKOTE 250mg
Treatment B: A single 2-tablet dose of DEPAKOTE ER tablet, 250mg. Each subject will have 2 treament period with this medication and 2 treatment periods with a single 2-tablet dose of Divalproex Sodium Extended-Release 250mg tablet.
Drug: Divalproex Sodium Extended-release 250mg
Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods
Other Name: DEPAKOTE 250mg
Drug: DEPAKOTE 250mg
Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.
Other Name: Divalproex Sodium Extended-Release 250mg

Detailed Description:

Study consists of a screening visit, four treatment periods and a final follow-up visit. Each treatment period consists of a four night in-house stay followed by two outpatient visits. Each treatment period will be separated by a washout period. During each treatment period, safety evaluations will include vital signs, physical exams, safety laboratory tests, weight measurement, electrocardiograms, adverse event collection and concomitant medication recording. Pharmacokinetic blood samples will be collected during each treatment period. Seizure activity will be recorded in a seizure diary during the study. A standardized high-fat, high-calorie meal will be served prior to each dose during each treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to understand, sign and date the informed consent form
  • Male or female 18 to 55 years old with a diagnosis of epilepsy who are stable
  • Body mass 18 to 34 kg/m, inclusive
  • Is continuously receiving a fixed dose of their AED medication(s)for a minimum of 30 days prior to screening
  • Stay on the same dosages of their routine concomitant medications throughout the study
  • Healthy, as determined by pre-study medical history, vital signs, physical exam, ECG and the opinion of the investigator
  • Normal renal function per laboratory test
  • No clinically relevant labs.
  • Negative for hepatitis B, C and HIV
  • For females, negative pregnancy test
  • Negative for drugs of abuse and alcohol
  • Nonsmoker or has not smoked within the past six months.
  • Some over-the-counter medications may be permitted at the discretion of the investigator
  • Able to communicate well and comply with study procedures, requirements and restrictions

Exclusion Criteria:

  • History or presence of clinically significant medical disorders
  • Have a current psychiatric disorder
  • History of status epilepticus within 90 days of screening
  • Any other condition that the investigator would feel could interfere with the safety of the subject or the study protocol.
  • Taking three or more AED medications
  • Use of felbamate, aspirin, carbapenem antibiotics, rifampin, ritonavir, macrolide antibiotics, cholestyramine, and/or risperidone.
  • Use of any investigational agent or medical device within 30 days of screening.
  • History of clinically significant drug allergy that in the opinion of the investigator may compromise the subject's safety or study results.
  • History of known hypersensitivity to divalproex sodium or its excipients
  • History of alcohol or drug abuse or dependence in the past 5 years
  • Consumed alcohol, caffeine or other xanthine-containing foods or beverages within 48 hours prior to each clinic admission.
  • Consumed grapefruit and/or grapefruit containing products within days prior to admission to the clinic on Day -1 and they agree not to consume grapefruit and/or grapefruit containing products for the duration of their study involvement
  • Participated in any strenuous physical exercise within 72 hours before admission to the clinic on Day 1 and agrees to abstain from the duration of their study involvement.
  • Acute illness at screening and/or at admission to the clinic
  • Lactose intolerance or unusual dietary habits.
  • Blood donation within 8 weeks of admission to this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898676

Locations
United States, Kansas
Vince & Associates Clinical Research, Inc. Recruiting
Overland Park, Kansas, United States, 66212
Contact: David Wood    913-696-1601    dwood@vinceandassociates.com   
Principal Investigator: Bradley D Vince, DO         
Sponsors and Collaborators
Vince & Associates Clinical Research, Inc.
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Bradley D. Vince, DO Vince & Associates Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Vince & Associates Clinical Research, Inc.
ClinicalTrials.gov Identifier: NCT01898676     History of Changes
Other Study ID Numbers: RIHSC #13-019D
Study First Received: June 17, 2013
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Vince & Associates Clinical Research, Inc.:
Extended-release divalproex sodium
Depakote ER

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014