Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance

NCT05886660 Phase 2 RECRUITING

The primary specific aim is to evaluate the use of intranasal scopolamine gel and sensory augmentation as an integrated countermeasure to mitigate motion sickness and enhance sensorimotor performance. The proposed intranasal scopolamine gel formulation (Defender Pharmaceuticals, Inc.) offers a safe non-invasive method to self-administer with a rapid onset of action. This study involves a comparison of motion sickness outcome measures when administering intranasal scopolamine gel versus placebo (Aim 1a), and then when administering intranasal scopolamine gel versus placebo with a sensory augmentation belt (Aim 1b).

Details

Lead sponsor	Repurposed Therapeutics, Inc.
Phase	Phase 2
Status	RECRUITING
Enrolment	30
Start date	2022-01-21
Completion	2024-09

Conditions

• Motion Sickness, Space
• Motion Sickness
• Sea Sickness

Interventions

• DPI-386 Nasal Gel
• Placebo Nasal Gel
• DPI-386 Nasal Gel
• Placebo Nasal Gel

Primary outcomes

• Motion sickness (MS) symptom severity using Pensacola Diagnostic Index (PDI) scale — 45 minutes
  The PDI scale ranges from 0 to 16 with higher numbers reflecting greater symptom severity (in this study a PDI score of 8 will be used as a motion sickness (MS) endpoint). During each session, the primary motion sickness symptoms will be recorded every minute during the capsule wave motion stimulation through the MS endpoint (PDI score ≥ 8 points) up to 45 min total.

Countries

United States