Trial Outcomes & Findings for Selegiline to Zelapar Switch Study in Parkinson Disease Patients (NCT NCT00640159)

Last Updated: 2023-08-09

Results Overview

Baseline assessments included a clinical global impression scale. This is compared to day 40 assessment. The clinical global impression scale consists of a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response. Each item is rated between 1-7. The minimum score is 3. The maximum score is 21. A score of 3 means the patient's symptoms are very much improved. A score of 21 means the patient is very much worse.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

48 participants

Primary outcome timeframe

baseline versus 40 days

Results posted on

2023-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Participants received 1.25mg of orally disintegrating selegiline for 10 days, and up titration of orally disintegrating selegiline to 2.5mg per day for the next 30 days or switched from oral selegiline to Zelapar 1.25mg per day titrated to 2.5mg per day.
Overall Study STARTED	48
Overall Study Patients Who Preferred Zydis Selegiline	25
Overall Study Patients Who Preferred Oral Selegiline	13
Overall Study Patients Who Had no Specific Preferred Medication	10
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Participants received 1.25mg of orally disintegrating selegiline for 10 days, and up titration of orally disintegrating selegiline to 2.5mg per day for the next 30 days or switched from oral selegiline to Zelapar 1.25mg per day titrated to 2.5mg per day.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Selegiline to Zelapar Switch Study in Parkinson Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=48 Participants Participants received 1.25mg of orally disintegrating selegiline for 10 days, and up titration of orally disintegrating selegiline to 2.5mg per day for the next 30 days or switched from oral selegiline to Zelapar 1.25mg per day titrated to 2.5mg per day.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	71.1 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline versus 40 days

Population: Clinical Global Impression scale comparison at day 40

Outcome measures

Outcome measures
Measure	All Study Participants n=48 Participants Participants received 1.25mg of orally disintegrating selegiline for 10 days, and up titration of orally disintegrating selegiline to 2.5mg per day for the next 30 days or switched from oral selegiline to Zelapar 1.25mg per day titrated to 2.5mg per day.
Clinical Global Impression Scale Clinical Global Impression scale at baseline	21 units on a scale Standard Deviation 7.2
Clinical Global Impression Scale Clinical Global Impression scale at day 40	27 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: baseline versus day 40

Population: MDS-UPDRS comparison at baseline and day 40

Baseline assessment include The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS). This is compared to day 40 assessment. The MDS-UPDRS consist of 65 items. Each item can be rated between 0-4. The minimum sore is Zero. Zero means the patient is absent of Parkinson's disease symptoms. The maximum score is 260. 260 means the patient has severe Parkinson's disease symptoms.

Outcome measures

Outcome measures
Measure	All Study Participants n=48 Participants Participants received 1.25mg of orally disintegrating selegiline for 10 days, and up titration of orally disintegrating selegiline to 2.5mg per day for the next 30 days or switched from oral selegiline to Zelapar 1.25mg per day titrated to 2.5mg per day.
MDS-UPDRS Scale at Baseline and Day 40 MDS-UPDRS at baseline	19 score on a scale Standard Deviation 3.5
MDS-UPDRS Scale at Baseline and Day 40 MDS-UPDRS at day 40	22 score on a scale Standard Deviation 4.1

Adverse Events

Zydis

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Selegiline

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

No Preference

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zydis n=25 participants at risk Patients who preferred Zydis selegiline	Selegiline n=13 participants at risk Patients who preferred oral selegiline	No Preference n=10 participants at risk Patients who have no specific preferred medication
Nervous system disorders increased dyskinesia	4.0% 1/25 • Number of events 1 • 6 week multicenter study	7.7% 1/13 • Number of events 1 • 6 week multicenter study	0.00% 0/10 • 6 week multicenter study
Nervous system disorders orthostatic hypotension	8.0% 2/25 • Number of events 2 • 6 week multicenter study	0.00% 0/13 • 6 week multicenter study	0.00% 0/10 • 6 week multicenter study
Nervous system disorders bad taste	0.00% 0/25 • 6 week multicenter study	7.7% 1/13 • Number of events 1 • 6 week multicenter study	0.00% 0/10 • 6 week multicenter study
Nervous system disorders fatigue	0.00% 0/25 • 6 week multicenter study	0.00% 0/13 • 6 week multicenter study	10.0% 1/10 • Number of events 1 • 6 week multicenter study
Nervous system disorders fall	4.0% 1/25 • Number of events 1 • 6 week multicenter study	0.00% 0/13 • 6 week multicenter study	0.00% 0/10 • 6 week multicenter study
Nervous system disorders freezing	4.0% 1/25 • Number of events 1 • 6 week multicenter study	0.00% 0/13 • 6 week multicenter study	0.00% 0/10 • 6 week multicenter study
Nervous system disorders dry mouth	0.00% 0/25 • 6 week multicenter study	7.7% 1/13 • Number of events 1 • 6 week multicenter study	0.00% 0/10 • 6 week multicenter study
Nervous system disorders anxiety	0.00% 0/25 • 6 week multicenter study	0.00% 0/13 • 6 week multicenter study	10.0% 1/10 • Number of events 1 • 6 week multicenter study

Additional Information

William G. Ondo , MD

Baylor College of Medicine/Houston Methodist

Phone: 713-363-8930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place