Bipolar 1 DisorderPhase 2NCT01674010
Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
A Phase 2 study testing ELND005, Lamotrigine and Valproic acid in people with Bipolar 1 Disorder, run by OPKO Health, Inc. at 82 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar 1 Disorder
- What is being tested?
- ELND005, Lamotrigine and Valproic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 309 participants
- Where
- 82 sitesin 9 countries
- Study dates
- Aug 2012to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
82 sites in 9 countries.
82 sites in 9 countries
United States41 sites
Elan Investigational Site
Atlanta, Georgia, 30308
Elan Investigational Site
Beachwood, Ohio, 44122
Elan Investigational Site
Bellevue, Washington, 98007
Elan Investigational Site
Birmingham, Alabama, 35294
Elan Investigational Site
Cerritos, California, 90703
Elan Investigational Site
Charleston, South Carolina, 29407
Elan Investigational Site
Cincinnati, Ohio, 45219
Elan Investigational Site
Cleveland, Ohio, 44106
Elan Investigational Site
Costa Mesa, California, 92626
Elan Investigational Site
Creve Coeur, Missouri, 63141
Elan Investigational Site
Escondido, California, 92025
Elan Investigational Site
Fresh Meadows, New York, 11366
Elan Investigational Site
Garden Grove, California, 92845
Elan Investigational Site
Glendale, Arizona, 85306
Elan Investigational Site
Houston, Texas, 77054
Elan Investigational Site
Hurst, Texas, 76053
Elan Investigational Site
Lincoln, Nebraska, 68526
Elan Investigational Site
Little Rock, Arkansas, 72201
Elan Investigational Site
Little Rock, Arkansas, 72211
Elan Investigational Site
Marlton, New Jersey, 08053
Elan Investigational Site
National City, California, 91950
Elan Investigational Site
New York, New York, 10065
Elan Investigational Site
North Miami, Florida, 33161
Elan Investigational Site
Norwich, Connecticut, 06360
Elan Investigational Site
Oakland Park, Florida, 33334
Elan Investigational Site
Oceanside, California, 92056
Elan Investigational Site
Oklahoma City, Oklahoma, 73112
Elan Investigational Site
Palo Alto, California, 94304
Elan Investigational Site
Philadelphia, Pennsylvania, 19139
Elan Investigational Site
Phoenix, Arizona, 85004
Elan Investigational Site
Raleigh, North Carolina, 27609
Elan Investigational Site
Riverside, California, 92506
Elan Investigational Site
Roswell, Georgia, 30076
Elan Investigational Site
Salt Lake City, Utah, 84106
Elan Investigational Site
San Antonio, Texas, 78229
Elan Investigational Site
San Diego, California, 92121
Elan Investigational Site
Santa Ana, California, 92701
Elan Investigational Site
St Louis, Missouri, 63118
Elan Investigational Site
St Louis, Missouri, 63128
Elan Investigational Site
Stanford, California, 94305
Elan Investigational Site
Tampa, Florida, 33613
Canada8 sites
Elan Investigational Site
Chatham, Ontario, N7M 5L9
Elan Investigational Site
Edmonton, Alberta, T6L 6W6
Elan Investigational Site
Halifax, Nova Scotia, B3H 2E2
Elan Investigational Site
Kelowna, British Columbia, V1Y 1Z9
Elan Investigational Site
Kingston, Ontario, K7L 4X3
Elan Investigational Site
London, Ontario, N6A 4H1
Elan Investigational Site
Toronto, Ontario, M4N 3M5
Elan Investigational Site
Toronto, Ontario, M5T 2S8
Bulgaria6 sites
Elan Investigational Site
Kardzhali, 6600
Elan Investigational Site
Pazardzhik, 4400
Elan Investigational Site
Sofia, 1000
Elan Investigational Site
Sofia, 1431
Elan Investigational Site
Varna, 9010
Elan Investigational Site
Vratsa, 3000
France6 sites
Elan Investigational Site
Bully-les-Mines, 62160
Elan Investigational Site
Dole, 39100
Elan Investigational Site
Élancourt, 78990
Elan Investigational Site
Nîmes, 30029
Elan Investigational Site
Toulouse, 31000
Elan Investigational Site
Toulouse, 31200
Czechia5 sites
Elan Investigational Site
Prague, 100 00
Elan Investigational Site
Prague, 120 00
Elan Investigational Site
Prague, 160 00
Elan Investigational Site
Prague, 18100
Elan Investigational Site
Strakonice, 386 29
Poland4 sites
Elan Investigational Site
Bydgoszcz, 85-156
Elan Investigational Site
Gdansk, 80-546
Elan Investigational Site
Lodz, 91-229
Elan Investigational Site
Tuszyn, 95-080
Romania4 sites
Elan Investigational Site
Brasov, 500366
Elan Investigational Site
Bucharest, 041914
Elan Investigational Site
Craiova, 200473
Elan Investigational Site
Sibiu, 550082
Spain4 sites
Elan Investigational Site
Barcelona, 08036
Elan Investigational Site
Oviedo, Principality of Asturias, 33011
Elan Investigational Site
Torrevieja, Alicante, 03186
Elan Investigational Site
Vitoria-Gasteiz, 01004
Turkey (Türkiye)4 sites
Elan Investigational Site
Ankara, 06100
Elan Investigational Site
Diyarbakır, 21280
Elan Investigational Site
Edirne, 22030
Elan Investigational Site
Istanbul, 34098
About this study
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
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
- Being tested
- ELND005, Lamotrigine, Valproic acid, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELND005Drug
Also called Scyllo-inositol
LamotrigineDrug
Valproic acidDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine or Valproic acid + ELND005 | Experimental | Lamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks Receives: 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 Receives: Drug: Lamotrigine; Drug: Valproic acid; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
The study was terminated early so no efficacy analysis was done, safety data are reported.
Measured: up to 48 weeks
Secondary outcomes (3)
Proportion of Study Participants With Recurrence of Any Mood Episode
Measured: up to 48 weeks
Time to Recurrence of a Depressive Episode
Measured: up to 48 weeks
Time to Recurrence of a Manic/Hypomanic or a Mixed Episode
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar 1 DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674010
- Sponsor's protocol ID
- ELND005-BPD201
- Other IDs
- 2012-001935-30
- Status last verified
- Oct 2019
- First submitted
- 24 Aug 2012
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01674010
- Acronym / sponsor ID
- ELND005-BPD201
- Conditions
- Bipolar 1 Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 309 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 12 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine or Valproic acid + ELND005 | Experimental | Drug: ELND005, Drug: Lamotrigine, Drug: Valproic acidLamotrigine or valproic acid plus ELND005 film coated tablets, 500mg BID for up to 48 weeks |
| Lamotrigine or Valproic acid + placebo | Placebo comparator | Drug: Lamotrigine, Drug: Valproic acid, Drug: PlaceboLamotrigine or valproic acid plus matched placebo BID for up to 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELND005Also: Scyllo-inositol | Drug | 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 |
Primary outcome
Treatment Emergent Adverse Events
Time frame: up to 48 weeks
The study was terminated early so no efficacy analysis was done, safety data are reported.
3 secondary outcomes
Proportion of Study Participants With Recurrence of Any Mood Episode
Time frame: up to 48 weeks
Time to Recurrence of a Depressive Episode
Time frame: up to 48 weeks
Time to Recurrence of a Manic/Hypomanic or a Mixed Episode
Time frame: up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
82 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELND005, Lamotrigine and Valproic acid in people with Bipolar 1 Disorder, run by OPKO Health, Inc. at 82 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Canada, Bulgaria, France, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (time frame: up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.