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DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder

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ClinicalTrials.gov Identifier: NCT02623504
Recruitment Status : Recruiting
First Posted : December 7, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Validus Pharmaceuticals

Brief Summary:
A phase 4 unequal randomization, double blind study to evaluate the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an Open label and long term maintenance treatment in children and adolescents aged 10-17 years diagnosed with acute manic or mixed Bipolar I Disorder

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Carbamazepine Drug: Placebo Phase 4

Detailed Description:
The primary objective of this study is to evaluate under double blind conditions the dose tolerance and safety of extended release Equetro (carbamazepine) versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and adolescents aged 10-17 year diagnosed with acute manic or mixed bipolar I disorder. The safety evaluations will be based on the occurrence of treatment-emergent adverse events, laboratory values, physical examination, vital signs ECG and trough serum level of study medication. The secondary objective is to evaluate under double blind conditions the efficacy of extended release Equetro versus placebo followed by an open label and long term maintenance treatment on extended release Equetro in children and Adolescents Aged 10-17 years diagnosed with acute manic or mixed Bipolar I disorder. Efficacy evaluations will be based on the measures of YMRS, CGI-S, CGI-I, CDRS-R. Manic episodes over double blind and open label periods will comprise the use of study medication and duration of night time sleep as monitored using a daily diary. Subject's will be enrolled in the double blind period for two months and evaluated on a weekly basis. Once completing the db phase they will continue on Equetro for long term maintenance for an additional six months. Placebo subject will have the opportunity to continue for another eight months in the study. The first two months will be the titration period as was done in the db phase and then they will have the option to continue in the study for an open long term maintenance for and additional 6 months. During the maintenance period subjects will be evaluated for safety and efficacy on a monthly basis. At the end of the study there will be a 30 day follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Study To Evaluate the Dose Tolerance and Safety of Equetro (Carbamazepine) Versus Placebo Followed by a Long-Term Maintenance in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Equetro
200-1200 mg of Equetro (carbamazepine) by mouth given in divided doses in the morning and in the evening. Dosage is titrated in 200 mg increments weekly as needed according to subject response.
Drug: Carbamazepine
200-1200 mg by mouth daily given in divided doses in the morning and the evening. Doses are titrated weekly in 200 mg increments based upon subject's response.
Other Name: Equetro

Placebo Comparator: Placebo
Placebo dosage to match the active Equetro treatment given in 2 daily doses in the morning and in the evening.
Drug: Placebo
Dosage to match active treatment by mouth twice daily in the morning and in the evening.




Primary Outcome Measures :
  1. Dose tolerance and safety of Equetro based on occurrence of adverse events, lab values, physical exams, vital signs, ECG's, and trough serum levels of study medications [ Time Frame: Duration of the study (8-10 months) ]

Secondary Outcome Measures :
  1. Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Young Mania Rating Score (YMRS) [ Time Frame: Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months) ]
  2. Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using Clinical Global Impressions - Improvement and Severity (CGI-I, CGI-S) [ Time Frame: Weekly during the double blind period (8 weeks), monthly during the maintenance period (6-8 months) ]
  3. Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured using the Children's Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Weekly during the double blind period, monthly during the maintenance period ]
  4. Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's manic episodes throughout the study period [ Time Frame: Duration of the study (8-10 months) ]
  5. Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the subject's weekly use of study medication [ Time Frame: Weekly for the duration of the study (8-10 months) ]
  6. Efficacy of Equetro in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder measured by assessing the duration of subject's nighttime sleep monitored using a diary or e-diary [ Time Frame: Weekly for the duration of the study (8-10 months) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written, signed and dated informed consent from subject, parents or legal guardians.
  • Subject must be willing to participate for the duration of the study (8-10 months)
  • Subject must meet DSM-V criteria for a primary diagnosis of bipolar I disorder.
  • MINI KID administered and ruled out other psychiatric diagnosis.
  • ADHD Rating Scale-IV is ruled negative.
  • YMRS Score 20 or greater
  • CGI-S score of 4 or greater
  • CGI-I Global Evaluation score of 4 or less
  • Must be aged between 10 and 17 years
  • Male and non-pregnant, non-lactating females who agree to comply with contraceptive requirements
  • Functioning at an age appropriate level intellectually as deemed by the Investigator
  • Subject has no co-morbid conditions that would affect efficacy, safety or tolerability or in any way interfere with the subject's participation in the study
  • Subject, parents and legal guardians are able to and willing to comply with study procedures and restrictions
  • Must have a satisfactory medical assessment with no clinically significant abnormalities
  • Able to avoid grapefruit and grapefruit juice for the duration of the study

Exclusion Criteria:

  • Subject has a current controlled or uncontrolled co-morbid psychiatric that could interfere with clinical assessments or study conduct.
  • Naive subjects whose symptoms are being controlled on their prescribed medication(s) will not be eligible to participate.
  • History of lack of therapeutic response to an adequate trial of carbamazepine to treat bipolar I disorder
  • Believed by the Investigator to be acutely at risk for suicidal or violent behavior towards him/her or others, or a history of a suicide attempt requiring general medical intervention
  • Subject's bipolar diagnosis is believed secondary to traumatic injury or another general medical condition.
  • A history or known presence of clinically significant cardiovascular, hepatic, hematological, immunological (including human immunodeficiency virus, gastro-intestinal or renal disease or any other unstable medical illness that could affect the action, absorption or disposition of the investigational product, or clinical or laboratory assessments
  • A history of aplastic anemia, agranulocytosis or bone marrow depression
  • A history of seizure disorder, other than a single childhood febrile seizure\
  • A history of severe, unstable asthma
  • Currently hospitalized for the treatment of psychiatric symptoms.
  • Presence of any mental disorder due to a general medical condition
  • Presence of abnormal thyroid function that is not adequately treated in the opinion of the Investigator
  • Use of ECT, any investigational drug, CYP450 3A4 inhibitors, antidepressants, anxiolytics, sedative hypnotics, antipsychotics, mood stabilizers, ADHD medications, or clozapine in a specified time period prior to the initiation of the study
  • Use of any nutraceutical to include, but not limited to any over the counter herbal preparations e.g. Gingko Biloba, St John's Wort, Kava Kava and Ephedra.
  • Positive urine drug screen
  • History of alcohol or other substance abuse or dependence as defined by DSM-V (except caffeine or nicotine) within the last 6months
  • Female subjects with a positive pregnancy test or who are pregnant, lactating, who are less than 6 months post partum, or who cannot be relied upon to use adequate birth control
  • Subjects who have previously been enrolled in the Phase IV Multi-Center , Open-Label Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Acute Manic or Mixed Bipolar I Disorder and subsequently withdrawn
  • Subjects with a body weight of ≤65kg
  • Family of investigational site staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623504


Contacts
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Contact: Richard A. Guarino, MD 973-265-2777 ext 121 rguarino@validuspharma.com
Contact: Robert Findling, MD 443-923-9188 rfindl@jhmi.edu

Locations
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United States, Florida
APG Research, LLC Recruiting
Orlando, Florida, United States, 32803
Contact: Heidi Maboudi    407-423-7149 ext 113    hmaboudi@aol.com   
Contact: Nikki Viera    407-420-6883 ext 165    nikki.apgresearch@gmail.com   
Principal Investigator: Morteza Nadjafi, MD         
United States, Maryland
Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Jennifer Willen    443-923-3846    willen@kennedykrieger.org   
Principal Investigator: Robert Findling, MD         
United States, Missouri
PsychCare Consultants Recruiting
St. Louis, Missouri, United States, 63128
Contact: Syed Zaidi, MD    314-616-7071    pccreseach@aol.com   
Principal Investigator: Mohd Azfar Malik, MD         
United States, Texas
Red Oak Psychiatry Associates, PA Recruiting
Houston, Texas, United States, 77090
Contact: Elissa Molloy-Plaza    281-893-4111 ext 155    ropa7@earthlink.net   
Principal Investigator: Lawrence Ginsberg, MD         
Sponsors and Collaborators
Validus Pharmaceuticals
Investigators
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Study Director: Robert Findling, MD John Hopkins - Kennedy Krieger Research
Principal Investigator: Lawrence Ginsberg, MD Red Oak Psychiatry
Principal Investigator: Morteza Nadjafi, MD APG Research
Principal Investigator: Mohd Azfar Malik, MD Psych Care Consultants Research

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Responsible Party: Validus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02623504     History of Changes
Other Study ID Numbers: VAL-EQP-001
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by Validus Pharmaceuticals:
Carbamazepine
Equetro
Bipolar I Disorder
Bipolar I Disorder in Children
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Carbamazepine
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers