Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Elan Pharmaceuticals
Information provided by (Responsible Party):
Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier:
NCT01674010
First received: August 24, 2012
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The primary purpose of this study is to determine whether ELND005 is effective in the maintenance treatment of bipolar 1 disorder when added to other therapies.


Condition Intervention Phase
Bipolar 1 Disorder
Drug: ELND005
Drug: Lamotrigine
Drug: Valproic acid
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients With Bipolar I Disorder

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:
  • Time to recurrence of any mood episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of study participants with recurrence of any mood episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of a depressive episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of a manic/hypomanic or a mixed episode [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lamotrigine or Valproic acid + ELND005
Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks
Drug: ELND005
Other Name: Scyllo-inositol
Drug: Lamotrigine Drug: Valproic acid
Placebo Comparator: Lamotrigine or Valproic acid + placebo
Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks
Drug: Lamotrigine Drug: Valproic acid Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets the DSM-IV-TR criteria for BPD I by the SCID, prior to the Screening Visit.
  • Has a history in the last 3 years of ≥ 1 manic or mixed episodes of sufficient severity that required hospitalization and/or treatment with a mood stabilizer or antipsychotic, or confirmed by a family member or medical records to ensure the episode fulfills the DSM-IV-TR criteria.
  • Has experienced a mood episode of any polarity within 4 months prior to the Screening Visit and responded to StOC therapy.
  • Is euthymic at the Screening Visit (ie, score of ≤ 12 on the MADRS and a score of ≤ 12 on the Y-MRS).
  • Is receiving maintenance treatment for his or her BPD I with either LTG or VPA; on stable doses for past 4 weeks and therapeutic drug levels (total VPA 50--125 µg/mL and LTG 10-50 µmol/L or as deemed appropriate by the investigator). Dose adjustments made for tolerability reasons will be acceptable.

A study patient must meet the following additional criteria to be eligible for randomization in the Double-blind Randomization Phase of this study:

- Maintained in a stable euthymic state during Phase 1, defined as Y-MRS and MADRS scores of ≤ 12, with the following exceptions: a maximum of 2 nonconsecutive excursions will be allowed throughout Phase 1. Excursions are defined as Y-MRS or MADRS scores >12 but ≤ 16.

Exclusion Criteria:

  • Woman of childbearing potential who is unwilling or unable to use an acceptable method of birth control or is using a prohibited contraceptive method.
  • Is found to be actively suicidal on the C-SSRS (answer of "yes" to question 4 or 5 [current or over the last 30 days]) or a score of ≥4 on the MADRS item 10 at the Screening Visit.
  • Has suboptimally treated thyroid disease as evidenced by thyroid-stimulating hormone (TSH) >3 mIU/L at the Screening Visit.
  • Has received electroconvulsive therapy (ECT) during the current episode or within 6 months prior to the Screening Visit.
  • Has an estimated glomerular filtration rate <40 mL/min/1.73 m2 according to the Modification of Diet in Renal Disease formula.

A study patient who meets ANY of the above and ANY of the criteria below will not be eligible for enrollment in the Double-blind Randomization Phase of this study:

  • Has current signs or symptoms of psychosis.
  • Has become actively suicidal as defined by C-SSRS answer of "yes" to question 4 or 5 (current or over the last 30 days) and/or has a score of ≥4 on MADRS item 10.
  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: NCT01674010

  Hide Study Locations
Locations
United States, Alabama
Elan Investigational Site
Birmingham, Alabama, United States, 35294
United States, Arizona
Elan Investigational Site
Glendale, Arizona, United States, 85306
Elan Investigational Site
Pheonix, Arizona, United States, 85004
United States, Arkansas
Elan Investigational Site
Little Rock, Arkansas, United States, 72211
Elan Investigational Site
Little Rock, Arkansas, United States, 72201
United States, California
Elan Investigational Site
Cerritos, California, United States, 90703
Elan Investigational Site
Costa Mesa, California, United States, 92626
Elan Investigational Site
Escondido, California, United States, 92025
Elan Investigational Site
Garden Grove, California, United States, 92845
Elan Investigational Site
National City, California, United States, 91950
Elan Investigational Site
Oceanside, California, United States, 92056
Elan Investigational Site
Palo Alto, California, United States, 94304
Elan Investigational Site
Riverside, California, United States, 92506
Elan Investigational Site
San Diego, California, United States, 92121
Elan Investigational Site
Santa Ana, California, United States, 92701
Elan Investigational Site
Stanford, California, United States, 94305
United States, Connecticut
Elan Investigational Site
Norwich, Connecticut, United States, 06360
United States, Florida
Elan Investigational Site
North Miami, Florida, United States, 33161
Elan Investigational Site
Oakland Park, Florida, United States, 33334
Elan Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
Elan Investigational Site
Atlanta, Georgia, United States, 30308
Elan Investigational Site
Roswell, Georgia, United States, 30076
United States, Missouri
Elan Investigational Site
Creve Coeur, Missouri, United States, 63141
Elan Investigational Site
St. Louis, Missouri, United States, 63118
Elan Investigational Site
St. Louis, Missouri, United States, 63128
United States, Nebraska
Elan Investigational Site
Lincoln, Nebraska, United States, 68526
United States, New Jersey
Elan Investigational Site
Marlton, New Jersey, United States, 08053
United States, New York
Elan Investigational Site
Fresh Meadows, New York, United States, 11366
Elan Investigational Site
New York, New York, United States, 10065
United States, North Carolina
Elan Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Elan Investigational Site
Beachwood, Ohio, United States, 44122
Elan Investigational Site
Cincinnati, Ohio, United States, 45219
Elan Investigational Site
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Elan Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Elan Investigational Site
Philadelphia, Pennsylvania, United States, 19139
United States, South Carolina
Elan Investigational Site
Charleston, South Carolina, United States, 29407
United States, Texas
Elan Investigational Site
Houston, Texas, United States, 77054
Elan Investigational Site
Hurst, Texas, United States, 76053
Elan Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Elan Investigational Site
Salt Lake City, Utah, United States, 84106
United States, Washington
Elan Investigational Site
Bellevue, Washington, United States, 98007
Bulgaria
Elan Investigational Site
Kardzhali, Bulgaria, 6600
Elan Investigational Site
Pazardzhik, Bulgaria, 4400
Elan Investigational Site
Sofia, Bulgaria, 1000
Elan Investigational Site
Sofia, Bulgaria, 1431
Elan Investigational Site
Varna, Bulgaria, 9010
Elan Investigational Site
Vratsa, Bulgaria, 3000
Canada, Alberta
Elan Investigational Site
Edmonton, Alberta, Canada, T6L 6W6
Canada, British Columbia
Elan Investigational Site
Kelowna, British Columbia, Canada, V1Y 1Z9
Canada, Nova Scotia
Elan Investigational Site
Halifax, Nova Scotia, Canada, B3H 2E2
Canada, Ontario
Elan Investigational Site
Chatham, Ontario, Canada, N7M 5L9
Elan Investigational Site
Kingston, Ontario, Canada, K7L 4X3
Elan Investigational Site
London, Ontario, Canada, N6A 4H1
Elan Investigational Site
Toronto, Ontario, Canada, M5T 2S8
Elan Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Czech Republic
Elan Investigational Site
Praha, Czech Republic, 18100
Elan Investigational Site
Praha, Czech Republic, 120 00
Elan Investigational Site
Praha, Czech Republic, 100 00
Elan Investigational Site
Praha, Czech Republic, 160 00
Elan Investigational Site
Strakonice, Czech Republic, 386 29
France
Elan Investigational Site
Bully-Les-Mines, France, 62160
Elan Investigational Site
Dole, France, 39100
Elan Investigational Site
Elancourt, France, 78990
Elan Investigational Site
Nimes, France, 30029
Elan Investigational Site
Toulouse, France, 31200
Elan Investigational Site
Toulouse, France, 31000
Poland
Elan Investigational Site
Bydgoszcz, Poland, 85-156
Elan Investigational Site
Gdansk, Poland, 80-546
Elan Investigational Site
Lodz, Poland, 91-229
Elan Investigational Site
Tuszyn, Poland, 95-080
Romania
Elan Investigational Site
Brasov, Romania, 500366
Elan Investigational Site
Bucharest, Romania, 041914
Elan Investigational Site
Craiova, Romania, 200473
Elan Investigational Site
Sibiu, Romania, 550082
Spain
Elan Investigational Site
Torrevieja, Alicante, Spain, 03186
Elan Investigational Site
Oviedo, Asturias, Spain, 33011
Elan Investigational Site
Barcelona, Spain, 08036
Elan Investigational Site
Vitoria, Spain, 01004
Turkey
Elan Investigational Site
Ankara, Turkey, 06100
Elan Investigational Site
Diyarbakir, Turkey, 21280
Elan Investigational Site
Edirne, Turkey, 22030
Elan Investigational Site
Istanbul, Turkey, 34098
Sponsors and Collaborators
Elan Pharma International Limited
Elan Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Elan Pharmaceuticals ( Elan Pharma International Limited )
ClinicalTrials.gov Identifier: NCT01674010     History of Changes
Other Study ID Numbers: ELND005-BPD201, 2012-001935-30
Study First Received: August 24, 2012
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lamotrigine
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014