NCT02708186

Brief Summary

This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 20, 2020

Completed
Last Updated

May 20, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

March 10, 2016

Results QC Date

April 14, 2020

Last Update Submit

May 9, 2020

Conditions

Dementia With Lewy BodiesREM Sleep Behavior DisorderParkinson's Disease Dementia

Keywords

Dementia with Lewy bodiesLewy bodiesREM sleep behavior disorderParkinson's disease dementia

Outcome Measures

Primary Outcomes (1)

  • Change in the Frequency of REM Sleep Behavior Disorders (RBD) From Baseline to the End of the Treatment Period (28 Days) Based on a Clinical Evaluator.

    The number of RBD (sum of simple/major and complex RBD events) per 10 minutes, based on video/audio assessment conducted at a sleep laboratory. Simple/major behaviors are jerks with higher movement amplitude, or intensity (e.g., whole body jerks, single limb jerk); Complex behaviors are Movements showing complexity of action and involving more muscle groups simultaneously or violent movements, and can be seen as the enactment of dream contents.

    28 days

Study Arms (2)

Nelotanserin

EXPERIMENTAL

Nelotanserin 80 mg

Drug: Nelotanserin

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NelotanserinDRUG

once daily, oral, 20-mg tablets

Nelotanserin
PlaceboDRUG

once daily, oral, matching tablets

Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnostic criteria
  • Presence of frequent REM sleep behavior episodes
  • Mini Mental State Examination score ≥ 18

You may not qualify if:

  • Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
  • Subjects' RBD symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
  • Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

US120

Birmingham, Alabama, 35294, United States

Location

US164

Phoenix, Arizona, 85013, United States

Location

US145

Sun City, Arizona, 85351, United States

Location

US143

Little Rock, Arkansas, 72205, United States

Location

US122

Englewood, Colorado, 80113, United States

Location

US180

Maitland, Florida, 32751, United States

Location

US154

Ocala, Florida, 34471, United States

Location

US113

Orlando, Florida, 32806, United States

Location

US152

Ormond Beach, Florida, 32174, United States

Location

US153

Tampa, Florida, 33613, United States

Location

US163

Atlanta, Georgia, 30331, United States

Location

US107

Indianapolis, Indiana, 46202, United States

Location

US132

Lenexa, Kansas, 66214, United States

Location

US129

Lincoln, Nebraska, 68526, United States

Location

US101

Chapel Hill, North Carolina, 27514, United States

Location

US159

New Bern, North Carolina, 28562, United States

Location

US147

Fargo, North Dakota, 58103, United States

Location

US111

Cincinnati, Ohio, 45229, United States

Location

US104

Cleveland, Ohio, 44195, United States

Location

US105

Columbus, Ohio, 43210, United States

Location

US173

Lincoln, Rhode Island, 02865, United States

Location

US128

Memphis, Tennessee, 38613, United States

Location

US131

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Stefani A, Santamaria J, Iranzo A, Hackner H, Schenck CH, Hogl B. Nelotanserin as symptomatic treatment for rapid eye movement sleep behavior disorder: a double-blind randomized study using video analysis in patients with dementia with Lewy bodies or Parkinson's disease dementia. Sleep Med. 2021 May;81:180-187. doi: 10.1016/j.sleep.2021.02.038. Epub 2021 Feb 25.

    PMID: 33714847DERIVED

MeSH Terms

Conditions

Lewy Body DiseaseREM Sleep Behavior Disorder

Interventions

nelotanserin

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersREM Sleep ParasomniasParasomniasSleep Wake Disorders

Results Point of Contact

Title
Senior Director of Clinical Research
Organization
Axovant Sciences GMBH
clinicaltrials@axovant.com
1-833-296-8268

Study Officials

  • Ilise Lombardo, MD

    Axovant Sciences, Inc., Clinical Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
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

March 10, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 20, 2020

Results First Posted

May 20, 2020

Record last verified: 2020-04

Locations

US(23)