Trial · NCT02215616

A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod

NCT02215616, Phase 2, Completed, Teva Branded Pharmaceutical Products R&D, Inc.; results first posted 2019-06-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod. Trials, record NCT02215616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02215616

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Trial

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

Title: A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of Laquinimod
NCT number: NCT02215616
Status: Completed
Phases: Phase 2
Enrollment: 352 participants, actual
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Conditions: Huntington's Disease
Interventions: Laquinimod, Placebo
First posted: 2014-08-13
Last updated: 2020-05-04
Other registries' IDs: eudract:2014-000418-75
Results first posted: 2019-06-19

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in UHDRS-TMS at Week 52	Baseline, Week 52	UHDRS is a research tool developed by Huntington Disease (HD) Study Group to provide a uniform assessment of the clinical features and course of HD. Components of the full UHDRS assess motor function, cognition, behaviour, functional abilities, independence scale and total functional capacities. Motor function assessment includes TMS and Total Functional Capacity (TFC) score. The UHDRS TMS assesses all the motor features of HD and includes maximal chorea, maximal dystonia, ocular pursuit, saccade initiation and velocity, dysarthria, tongue protrusion, finger tapping, hand pronation and supination, luria, rigidity, bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these was rated on a scale of 0 (normal motor function) to 4 (severely impaired motor function). TMS score is a sum of individual scores ranging from 0 (normal motor function) to 124 (severely impaired motor function). Lower TMS scores indicate better motor function.
Secondary	Percent Change From Baseline in Caudate Volume (Brain Atrophy) at Week 52	Baseline, Week 52	Brain atrophy was assessed using magnetic resonance imaging (MRI) measures of caudate volume. Caudate volume atrophy is a sensitive biomarker in very early HD and correlates with disease progression. Brain atrophy in the caudate refers to the shrinkage in volume, so that a decrease in volume is a positive value, while an increase in volume is a negative value. Percent change in caudate volume at Week 52 was calculated as the change in caudate volume since the baseline visit, divided by the baseline caudate volume and multiplied by 100.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in UHDRS-TMS at Week 52	Baseline, Week 52	Full analysis set (FAS) included all participants in the ITT population (all randomized participants) who received at least 1 dose of study drug and had at least 1 post-baseline TMS assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.	units on a scale	MEAN
SECONDARY	Percent Change From Baseline in Caudate Volume (Brain Atrophy) at Week 52	Baseline, Week 52	FAS included all participants in the ITT population (all randomized participants) who received at least 1 dose of study drug and had at least 1 post-baseline TMS assessment. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.	percent change	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Change From Baseline in UHDRS-TMS at Week 52	Placebo	1.3	Standard Deviation 8.00	units on a scale
Change From Baseline in UHDRS-TMS at Week 52	Laquinimod 0.5 mg	1.4	Standard Deviation 8.34	units on a scale
Change From Baseline in UHDRS-TMS at Week 52	Laquinimod 1.0 mg	2.0	Standard Deviation 7.27	units on a scale
Change From Baseline in UHDRS-TMS at Week 52	Laquinimod 1.5 mg	11.0	Standard Deviation 7.12	units on a scale
Percent Change From Baseline in Caudate Volume (Brain Atrophy) at Week 52	Placebo	5.13	Standard Deviation 3.265	percent change
Percent Change From Baseline in Caudate Volume (Brain Atrophy) at Week 52	Laquinimod 0.5 mg	4.03	Standard Deviation 3.275	percent change
Percent Change From Baseline in Caudate Volume (Brain Atrophy) at Week 52	Laquinimod 1.0 mg	3.14	Standard Deviation 3.360	percent change
Percent Change From Baseline in Caudate Volume (Brain Atrophy) at Week 52	Laquinimod 1.5 mg	4.11	Standard Deviation 0.598	percent change

Source ClinicalTrials.gov

Participant flow16

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	108
Overall Study	STARTED	Laquinimod 0.5 mg	107
Overall Study	STARTED	Laquinimod 1.0 mg	107
Overall Study	STARTED	Laquinimod 1.5 mg	30
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	108
Overall Study	Received at Least 1 Dose of Study Drug	Laquinimod 0.5 mg	107
Overall Study	Received at Least 1 Dose of Study Drug	Laquinimod 1.0 mg	106
Overall Study	Received at Least 1 Dose of Study Drug	Laquinimod 1.5 mg	29
Overall Study	COMPLETED	Placebo	97
Overall Study	COMPLETED	Laquinimod 0.5 mg	90

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events224

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	Events
other	Abdominal pain	Gastrointestinal disorders	Placebo	1	108	1
other	Abdominal pain	Gastrointestinal disorders	Laquinimod 0.5 mg	7	107	10
other	Abdominal pain	Gastrointestinal disorders	Laquinimod 1.0 mg	2	106	2
other	Abdominal pain	Gastrointestinal disorders	Laquinimod 1.5 mg	1	29	1
other	Constipation	Gastrointestinal disorders	Placebo	3	108	3
other	Constipation	Gastrointestinal disorders	Laquinimod 0.5 mg	3	107	3
other	Constipation	Gastrointestinal disorders	Laquinimod 1.0 mg	3	106	3
other	Constipation	Gastrointestinal disorders	Laquinimod 1.5 mg	2	29	2
other	Diarrhoea	Gastrointestinal disorders	Placebo	9	108	9
other	Diarrhoea	Gastrointestinal disorders	Laquinimod 0.5 mg	12	107	14

1 to 10 of 224Source ClinicalTrials.gov

See all 224 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	1	108
Total, all-cause mortality	Laquinimod 0.5 mg	0	107
Total, all-cause mortality	Laquinimod 1.0 mg	0	106
Total, all-cause mortality	Laquinimod 1.5 mg	0	29
Total, other adverse events	Placebo	62	108
Total, other adverse events	Laquinimod 0.5 mg	69	107
Total, other adverse events	Laquinimod 1.0 mg	58	106
Total, other adverse events	Laquinimod 1.5 mg	19	29
Total, serious adverse events	Placebo	8	108
Total, serious adverse events	Laquinimod 0.5 mg	7	107

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27296315	DERIVED	PubMed
38280392	DERIVED	PubMed

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/NCT02215616

GET https://conductscience.org/api/trials/v1/NCT02215616/events?page=2

API reference For AI assistants