Trial Outcomes & Findings for Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients (NCT NCT00761137)

Results Overview

Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Before and 120 min after treatment administration

Results posted on

2015-10-12

Participant Flow

Four interventions, subjects were randomly assigned to one of 16 sequences.

Participant milestones

Participant milestones
Measure	All Participants subjects randomly received (blinded) each of the 4 doses at different visits - 0 mg, 0.3 mg, 1mg, 3 mg Drug: Tropicamide
Overall Study STARTED	19
Overall Study Placebo	19
Overall Study 0.3 mg Tropicamide	19
Overall Study 1 mg Tropicamide	19
Overall Study 3 mg Tropicamide	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=19 Participants This study was a double-blind, randomized, placebo controlled, two-phased, Latin-square crossover study. Subjects received three single-doses of tropicamide or placebo in random order, with a 7-day washout period.
Age, Continuous	67 years STANDARD_DEVIATION 12 • n=99 Participants
Sex: Female, Male Female	4 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Region of Enrollment Argentina	19 participants n=99 Participants

PRIMARY outcome

Timeframe: Before and 120 min after treatment administration

Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.

Outcome measures

Outcome measures
Measure	Tropicamide - Placebo n=19 Participants Each subject randomly received blinded a placebo thin film containing no active drug ingredient	Tropicamide - 0.3 mg n=19 Participants Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient	Tropicamide - 1 mg n=19 Participants Each subject randomly received blinded a thin film containing 1 mg active drug ingredient	Tropicamide 3 mg n=19 Participants Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
Sialorrhea Visual Analogue Scale (VAS)	-0.55 cm on VAS Standard Deviation 0.54	-1.08 cm on VAS Standard Deviation 0.54	-1.53 cm on VAS Standard Deviation 0.52	-0.81 cm on VAS Standard Deviation 0.51

SECONDARY outcome

Timeframe: Before and 75 minutes after treatment administration

Population: Percentage saliva volume change was determined in the last seven (7) patients enrolled.

Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined.

Outcome measures

Outcome measures
Measure	Tropicamide - Placebo n=7 Participants Each subject randomly received blinded a placebo thin film containing no active drug ingredient	Tropicamide - 0.3 mg n=7 Participants Each subject randomly received blinded a thin film containing 0.3 mg active drug ingredient	Tropicamide - 1 mg n=7 Participants Each subject randomly received blinded a thin film containing 1 mg active drug ingredient	Tropicamide 3 mg n=7 Participants Each subject randomly received blinded a thin film containing 3 mg active drug ingredient
Percentage Change in Saliva Volume	-5 percentage change of saliva volume Interval -27.0 to 17.0	-27 percentage change of saliva volume Interval -48.0 to -6.0	-33 percentage change of saliva volume Interval -60.0 to -7.0	-20 percentage change of saliva volume Interval -33.0 to -7.0

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Katzman

NeuroHealing Pharmaceuticals

Phone: 617-965-0872

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60