Trial Outcomes & Findings for Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone (NCT NCT00324896)

NCT ID: NCT00324896

Last Updated: 2013-05-31

Results Overview

Total sleep time in hours

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 30 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2013-05-31

Participant Flow

Patients were recruited between 2006 and 2009, from the RWJMS movement disorder clinic and advertising to local support groups.

Patients who met inclusion and exclusion criteria were enrolled.

Participant milestones

Measure	Eszopiclone eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime eszopiclone : eszopiclone	Placebo Those randomly assigned to matching placebo, took their dose each night at bedtime
Overall Study STARTED	15	15
Overall Study COMPLETED	12	7
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone

Baseline characteristics by cohort

Measure	Eszopiclone n=15 Participants eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime eszopiclone : eszopiclone	Placebo n=15 Participants Those randomly assigned to matching placebo, took their dose each night at bedtime	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age Continuous	60.3 years STANDARD_DEVIATION 7.9 • n=5 Participants	53.1 years STANDARD_DEVIATION 10.5 • n=7 Participants	56.1 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: intent to treat approach

Total sleep time in hours

Outcome measures

Measure	Eszopiclone n=15 Participants eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime eszopiclone : eszopiclone	Placebo n=15 Participants Those randomly assigned to matching placebo, took their dose each night at bedtime
TST	5.7 hours Standard Deviation 1.16	6.0 hours Standard Deviation 1.16

SECONDARY outcome

Timeframe: 6 weeks

Population: intent to treat

Wake after sleep onset in minutes

Outcome measures

Measure	Eszopiclone n=15 Participants eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime eszopiclone : eszopiclone	Placebo n=15 Participants Those randomly assigned to matching placebo, took their dose each night at bedtime
WASO	17 minutes Standard Deviation 50	46 minutes Standard Deviation 45

Adverse Events

Eszopiclone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Eszopiclone n=15 participants at risk eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime eszopiclone : eszopiclone	Placebo n=15 participants at risk Those randomly assigned to matching placebo, took their dose each night at bedtime
Nervous system disorders sedation	13.3% 2/15 • Number of events 2	0.00% 0/15
Nervous system disorders dizziness	6.7% 1/15 • Number of events 1	0.00% 0/15
Nervous system disorders daytime fatigue	0.00% 0/15	20.0% 3/15 • Number of events 3
Nervous system disorders increase Parkinson's related rigidity	0.00% 0/15	6.7% 1/15 • Number of events 1

Additional Information

Matthew Menza, MD

UMDNJ - RWJMS

Phone: 732-235-4440

Email: menza@umdnj.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place