Overview

Study to Assess Safety, Tolerability and MTD of a Central Pattern Generator-activating Tritherapy (SPINALON) in Patients With Chronic Spinal Cord Injury

Status:
Completed

Trial end date:
2015-08-01

Target enrollment:

Participant gender:

Summary

As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporarily induce episodes of involuntary locomotor movements. The primary objective of this Phase I/IIa study is to assess safety and tolerability of a single escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured patients. As a secondary objective, preliminary evidence of efficacy will also be sought.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Nordic Life Science Pipeline Inc.

Collaborator:

United States Department of Defense

Treatments:

Buspirone
Levodopa