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

NCT01674010 | Terminated Phase 2 Results DMC

• 2 other identifiers: ELND005-BPD2012012-001935-30
• Study Type: interventional
• Target: 309
• Locations: 9 countries
• Sites: 82

Brief Summary

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.

Conditions

Bipolar 1 Disorder

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events

  The study was terminated early so no efficacy analysis was done, safety data are reported.

  up to 48 weeks

Secondary Outcomes (3)

• Proportion of Study Participants With Recurrence of Any Mood Episode

  up to 48 weeks

• Time to Recurrence of a Depressive Episode

  up to 48 weeks

• Time to Recurrence of a Manic/Hypomanic or a Mixed Episode

  up to 48 weeks

Study Arms (2)

Lamotrigine or Valproic acid + ELND005

EXPERIMENTAL

Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks

Drug: ELND005; Drug: Lamotrigine; Drug: Valproic acid

Lamotrigine or Valproic acid + placebo

PLACEBO COMPARATOR

Lamotrigine or valproic acid plus matched placebo BID for up to 48 weeks

Drug: Lamotrigine; Drug: Valproic acid; Drug: Placebo

Interventions

ELND005 DRUG

Also known as: Scyllo-inositol

Lamotrigine or Valproic acid + ELND005

Lamotrigine DRUG

Lamotrigine or Valproic acid + ELND005; Lamotrigine or Valproic acid + placebo

Valproic acid DRUG

Lamotrigine or Valproic acid + ELND005; Lamotrigine or Valproic acid + placebo

Placebo DRUG

Lamotrigine or Valproic acid + placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OPKO Health, Inc.: lead
• Elan Pharmaceuticals: collaborator

Study Sites (82)

Elan Investigational Site

Birmingham, Alabama, 35294, United States

Location

Elan Investigational Site

Glendale, Arizona, 85306, United States

Location

Elan Investigational Site

Phoenix, Arizona, 85004, United States

Location

Elan Investigational Site

Little Rock, Arkansas, 72201, United States

Location

Elan Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Elan Investigational Site

Cerritos, California, 90703, United States

Location

Elan Investigational Site

Costa Mesa, California, 92626, United States

Location

Elan Investigational Site

Escondido, California, 92025, United States

Location

Elan Investigational Site

Garden Grove, California, 92845, United States

Location

Elan Investigational Site

National City, California, 91950, United States

Location

Elan Investigational Site

Oceanside, California, 92056, United States

Location

Elan Investigational Site

Palo Alto, California, 94304, United States

Location

Elan Investigational Site

Riverside, California, 92506, United States

Location

Elan Investigational Site

San Diego, California, 92121, United States

Location

Elan Investigational Site

Santa Ana, California, 92701, United States

Location

Elan Investigational Site

Stanford, California, 94305, United States

Location

Elan Investigational Site

Norwich, Connecticut, 06360, United States

Location

Elan Investigational Site

North Miami, Florida, 33161, United States

Location

Elan Investigational Site

Oakland Park, Florida, 33334, United States

Location

Elan Investigational Site

Tampa, Florida, 33613, United States

Location

Elan Investigational Site

Atlanta, Georgia, 30308, United States

Location

Elan Investigational Site

Roswell, Georgia, 30076, United States

Location

Elan Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Elan Investigational Site

St Louis, Missouri, 63118, United States

Location

Elan Investigational Site

St Louis, Missouri, 63128, United States

Location

Elan Investigational Site

Lincoln, Nebraska, 68526, United States

Location

Elan Investigational Site

Marlton, New Jersey, 08053, United States

Location

Elan Investigational Site

Fresh Meadows, New York, 11366, United States

Location

Elan Investigational Site

New York, New York, 10065, United States

Location

Elan Investigational Site

Raleigh, North Carolina, 27609, United States

Location

Elan Investigational Site

Beachwood, Ohio, 44122, United States

Location

Elan Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Elan Investigational Site

Cleveland, Ohio, 44106, United States

Location

Elan Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

Elan Investigational Site

Philadelphia, Pennsylvania, 19139, United States

Location

Elan Investigational Site

Charleston, South Carolina, 29407, United States

Location

Elan Investigational Site

Houston, Texas, 77054, United States

Location

Elan Investigational Site

Hurst, Texas, 76053, United States

Location

Elan Investigational Site

San Antonio, Texas, 78229, United States

Location

Elan Investigational Site

Salt Lake City, Utah, 84106, United States

Location

Elan Investigational Site

Bellevue, Washington, 98007, United States

Location

Elan Investigational Site

Kardzhali, 6600, Bulgaria

Location

Elan Investigational Site

Pazardzhik, 4400, Bulgaria

Location

Elan Investigational Site

Sofia, 1000, Bulgaria

Location

Elan Investigational Site

Sofia, 1431, Bulgaria

Location

Elan Investigational Site

Varna, 9010, Bulgaria

Location

Elan Investigational Site

Vratsa, 3000, Bulgaria

Location

Elan Investigational Site

Edmonton, Alberta, T6L 6W6, Canada

Location

Elan Investigational Site

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Elan Investigational Site

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Elan Investigational Site

Chatham, Ontario, N7M 5L9, Canada

Location

Elan Investigational Site

Kingston, Ontario, K7L 4X3, Canada

Location

Elan Investigational Site

London, Ontario, N6A 4H1, Canada

Location

Elan Investigational Site

Toronto, Ontario, M4N 3M5, Canada

Location

Elan Investigational Site

Toronto, Ontario, M5T 2S8, Canada

Location

Elan Investigational Site

Prague, 100 00, Czechia

Location

Elan Investigational Site

Prague, 120 00, Czechia

Location

Elan Investigational Site

Prague, 160 00, Czechia

Location

Elan Investigational Site

Prague, 18100, Czechia

Location

Elan Investigational Site

Strakonice, 386 29, Czechia

Location

Elan Investigational Site

Bully-les-Mines, 62160, France

Location

Elan Investigational Site

Dole, 39100, France

Location

Elan Investigational Site

Élancourt, 78990, France

Location

Elan Investigational Site

Nîmes, 30029, France

Location

Elan Investigational Site

Toulouse, 31000, France

Location

Elan Investigational Site

Toulouse, 31200, France

Location

Elan Investigational Site

Bydgoszcz, 85-156, Poland

Location

Elan Investigational Site

Gdansk, 80-546, Poland

Location

Elan Investigational Site

Lodz, 91-229, Poland

Location

Elan Investigational Site

Tuszyn, 95-080, Poland

Location

Elan Investigational Site

Brasov, 500366, Romania

Location

Elan Investigational Site

Bucharest, 041914, Romania

Location

Elan Investigational Site

Craiova, 200473, Romania

Location

Elan Investigational Site

Sibiu, 550082, Romania

Location

Elan Investigational Site

Torrevieja, Alicante, 03186, Spain

Location

Elan Investigational Site

Oviedo, Principality of Asturias, 33011, Spain

Location

Elan Investigational Site

Barcelona, 08036, Spain

Location

Elan Investigational Site

Vitoria-Gasteiz, 01004, Spain

Location

Elan Investigational Site

Ankara, 06100, Turkey (Türkiye)

Location

Elan Investigational Site

Diyarbakır, 21280, Turkey (Türkiye)

Location

Elan Investigational Site

Edirne, 22030, Turkey (Türkiye)

Location

Elan Investigational Site

Istanbul, 34098, Turkey (Türkiye)

Location

MeSH Terms

Interventions

scyllitol; Lamotrigine; Valproic Acid

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Aleksandra Pastrak,MD, PhD, VP of Clinical Development and Medical Officer
• Organization: Transition Therapeutics Ireland Limited

apastrak@transitiontherapeutics.com

+1 416 263 1227

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 21, 2019
• Results First Posted: October 12, 2015

Record last verified: 2019-10

Locations

BU (6); PL (4); TU (4); CZ (5); US (41); FR (6); CA (8); RO (4); ES (4)