Who is sponsoring NCT01844648?

NCT01844648 is sponsored by NeuroHealing Pharmaceuticals Inc..

What condition does NCT01844648 study?

NCT01844648 studies Sialorrhea (Excessive Drooling).

What drugs are being tested in NCT01844648?

Interventions: NH004 tropicamide, NH004 Placebo.

What is the status of NCT01844648?

NCT01844648 is currently COMPLETED.

Last reviewed 2015-12-08 · How we verify

A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Safety and Efficacy of Tropicamide 1 mg Intra-oral Slow Dissolving Muco-adhesive Thin Films to Reduce Hypersalivation in PD Patients Manifesting Sialorrhea Complaints

NCT01844648 Phase 2 COMPLETED

To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.

Details

Lead sponsor	NeuroHealing Pharmaceuticals Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	30
Start date	2013-04
Completion	2015-12

Conditions

Sialorrhea (Excessive Drooling)

Interventions

NH004 tropicamide
NH004 Placebo

Primary outcomes

modified Teachers Drooling Scale (% responding) — one week
The primary endpoint for this trial is the difference in responder rate between tropicamide and placebo. Responders will be defined as subjects whose mean sialorrhea score improved by at least 30% as compared to baseline in the 9-point modified Teachers Drooling Scale (mTDS).

Countries

France