Last reviewed · How we verify

NCT03327792

Mavoglurant in Alcohol Drinking

Completed Phase 1 Results posted Last updated 6 August 2024
What this trial tests

Phase 1 trial testing Mavoglurant in Alcohol Drinking in 34 participants. Completed in 13 July 2023.

Timeline
7 February 2018
Primary endpoint
13 July 2023
13 July 2023

Quick facts

Lead sponsorYale University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment34
Start date7 February 2018
Primary completion13 July 2023
Estimated completion13 July 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

Adults 21 to 50, any sex, with Alcohol Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Abnormal Labs and Adverse Events Primary · Day 10

Number of participants (at Day 10; after both alcohol sessions and completed course of mavoglurant) with abnormal lab values or adverse events related to the interaction of alcohol and mavoglurant

Number of participants that reported Adverse Event(s)
GroupValue95% CI
200 mg Mavoglurant9
Placebo8
Abnormal/Clinically Significant lab values after Mavoglurant and alcohol administration
GroupValue95% CI
200 mg Mavoglurant0
Placebo0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

200 mg Mavoglurant
Serious: 0/17 (0%)
Deaths: 0/17
Placebo
Serious: 0/17 (0%)
Deaths: 0/17
Other adverse events (48 terms — click to expand)

ReactionSystem200 mg MavoglurantPlacebo
DizzinessNervous system disorders
InsomniaNervous system disorders
NauseaGastrointestinal disorders
Nervousness / AnxietyPsychiatric disorders
HeadacheNervous system disorders
Appetite ChangeGastrointestinal disorders
Lack of FocusNervous system disorders
Mania/HyperactivityPsychiatric disorders
FatigueNervous system disorders
Feeling High/IntoxicatedPsychiatric disorders
VomitingGastrointestinal disorders
LightheadedNervous system disorders
ConfusionNervous system disorders
ConstipationGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
Extra sense of focusNervous system disorders
Racing HeartCardiac disorders
DissociationNervous system disorders
Acid IndigestionGastrointestinal disorders
Sore ArmMusculoskeletal and connective tissue disorders
Back AcheMusculoskeletal and connective tissue disorders
CongestionRespiratory, thoracic and mediastinal disorders
DiarrheaGastrointestinal disorders
Face NumbnessNervous system disorders
Frequent UrinationRenal and urinary disorders
Good Mood / AwakeNervous system disorders
Hurt AnkleMusculoskeletal and connective tissue disorders
IrritablePsychiatric disorders
ItchySkin and subcutaneous tissue disorders
Memory LossNervous system disorders
Mood AlteredPsychiatric disorders
Mouth and Throat PainGeneral disorders
Moving/Walking SlowerMusculoskeletal and connective tissue disorders
Muscle PainMusculoskeletal and connective tissue disorders
Muscle TwitchMusculoskeletal and connective tissue disorders
Night SweatsNervous system disorders
NightmaresPsychiatric disorders
Pimples/Face SwellingSkin and subcutaneous tissue disorders
SadPsychiatric disorders
Social AnxietySocial circumstances

Data from ClinicalTrials.gov NCT03327792 adverse events section.

Sponsor's own description

The purpose of this alcohol-interaction pilot study is to provide information on the effect of mavoglurant on the pharmacokinetics of alcohol and on alcohol responses, including stimulation, sedation, intoxication, body sway and physiological responses. The investigators propose to test the effects of 200 mg mavoglurant versus placebo on alcohol related responses. This is a between subjects double blind randomized design in which the investigators plan to run 40 subjects to obtain 28 completers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
    Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z

Verify or expand the search:

Other trials of Mavoglurant

Trials testing the same drug.

Other recruiting trials for Alcohol Drinking

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03327792.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing