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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Spinal Cord Injury
Interventions
DRUG

SPINALON (buspirone + levodopa + cardidopa)

The proposed study is a combination of 1 and 2-arm designs. First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of the study drug, and the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively (not simultaneously) with increasing doses of SPINALON, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.This will be followed by a 2-arm composed of 1 group with 1 subject receiving placebo and 1 larger group (10 subjects) who will receive SPINALON at MTD as identified in the previous 2-arm groups.

Trial Locations (1)

H3G 1A4

McGill University Health Centre (Montreal General Hospital), Montreal

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Nordic Life Science Pipeline Inc.

OTHER

NCT01484184 - Study to Assess Safety, Tolerability and MTD of a Central Pattern Generator-activating Tritherapy (SPINALON) in Patients With Chronic Spinal Cord Injury | Biotech Hunter | Biotech Hunter