Trial · NCT01674010

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

NCT01674010, Phase 2, Terminated, OPKO Health, Inc.; results first posted 2015-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder. Trials, record NCT01674010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01674010

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of ELND005 as an Adjunctive Maintenance Treatment in Bipolar I Disorder
NCT number: NCT01674010
Status: Terminated
Phases: Phase 2
Enrollment: 309 participants, actual
Lead sponsor: OPKO Health, Inc.
Conditions: Bipolar 1 Disorder
Interventions: ELND005, Lamotrigine, Valproic acid, Placebo
First posted: 2012-08-28
Last updated: 2019-10-21
Other registries' IDs: eudract:2012-001935-30
Results first posted: 2015-10-12

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Emergent Adverse Events	up to 48 weeks	The study was terminated early so no efficacy analysis was done, safety data are reported.
Secondary	Proportion of Study Participants With Recurrence of Any Mood Episode	up to 48 weeks
Secondary	Time to Recurrence of a Depressive Episode	up to 48 weeks
Secondary	Time to Recurrence of a Manic/Hypomanic or a Mixed Episode	up to 48 weeks

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Emergent Adverse Events	up to 48 weeks	TEAEs reported for Phase 2 were from the entire study period	participants	NUMBER
SECONDARY	Proportion of Study Participants With Recurrence of Any Mood Episode	up to 48 weeks	Study was prematurely terminated, no data were collected for this Outcome Measure
SECONDARY	Time to Recurrence of a Depressive Episode	up to 48 weeks	Study was prematurely terminated, no data were collected for this Outcome Measure
SECONDARY	Time to Recurrence of a Manic/Hypomanic or a Mixed Episode	up to 48 weeks	Study was prematurely terminated, no data were collected for this Outcome Measure

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Treatment Emergent Adverse Events	Open Treatment Phase 1 ELND005 500 mg BID	153	participants
Treatment Emergent Adverse Events	Phase 2 Placebo	45	participants
Treatment Emergent Adverse Events	Phase 2 ELND005 500 mg BID	45	participants

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Open Treatment Phase 1	STARTED	Open Treatment Phase 1 ELND005 500 mg BID	309
Open Treatment Phase 1	STARTED	Phase 2 Placebo	0
Open Treatment Phase 1	STARTED	Phase 2 ELND005 500 mg BID	0
Open Treatment Phase 1	COMPLETED	Open Treatment Phase 1 ELND005 500 mg BID	129
Open Treatment Phase 1	COMPLETED	Phase 2 Placebo	0
Open Treatment Phase 1	COMPLETED	Phase 2 ELND005 500 mg BID	0
Open Treatment Phase 1	NOT COMPLETED	Open Treatment Phase 1 ELND005 500 mg BID	180
Open Treatment Phase 1	NOT COMPLETED	Phase 2 Placebo	0
Open Treatment Phase 1	NOT COMPLETED	Phase 2 ELND005 500 mg BID	0
Randomization Phase 2	STARTED	Open Treatment Phase 1 ELND005 500 mg BID	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events78

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Gastrointestinal disorders	Gastrointestinal disorders	Open Treatment Phase 1 ELND005 500 mg BID	29	309
other	Gastrointestinal disorders	Gastrointestinal disorders	Phase 2 Placebo	12	65
other	Gastrointestinal disorders	Gastrointestinal disorders	Phase 2 ELND005 500 mg BID	11	64
other	General disorders and administration site conditions	General disorders	Open Treatment Phase 1 ELND005 500 mg BID	10	309
other	General disorders and administration site conditions	General disorders	Phase 2 Placebo	2	65
other	General disorders and administration site conditions	General disorders	Phase 2 ELND005 500 mg BID	5	64
other	Infections and infestations	Infections and infestations	Open Treatment Phase 1 ELND005 500 mg BID	47	309
other	Infections and infestations	Infections and infestations	Phase 2 Placebo	20	65
other	Infections and infestations	Infections and infestations	Phase 2 ELND005 500 mg BID	20	64
other	Injury poisoning and procedural complications	Injury, poisoning and procedural complications	Open Treatment Phase 1 ELND005 500 mg BID	19	309

1 to 10 of 78Source ClinicalTrials.gov

See all 78 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Open Treatment Phase 1 ELND005 500 mg BID
Total, all-cause mortality	Phase 2 Placebo
Total, all-cause mortality	Phase 2 ELND005 500 mg BID
Total, other adverse events	Open Treatment Phase 1 ELND005 500 mg BID	153	309
Total, other adverse events	Phase 2 Placebo	45	65
Total, other adverse events	Phase 2 ELND005 500 mg BID	45	64
Total, serious adverse events	Open Treatment Phase 1 ELND005 500 mg BID	12	309
Total, serious adverse events	Phase 2 Placebo	3	65
Total, serious adverse events	Phase 2 ELND005 500 mg BID	3	64

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01674010

GET https://conductscience.org/api/trials/v1/NCT01674010/events?page=2

API reference For AI assistants