Clinical trial

Improving Ventilatory Capacity in Those With Chronic High Level SCI

Name
2016P002409
Description
The purpose of this study is to find out if taking the drug Buspar will increase breathing capacity in individuals with spinal cord injuries.
Trial arms
Trial start
2020-11-29
Estimated PCD
2023-11-29
Trial end
2024-11-29
Status
Recruiting
Phase
Early phase I
Treatment
Buspirone
Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days.
Arms:
Buspirone
Other names:
BuSpar, Buspirone Hydrochloride
Placebo
Subjects take placebo pills (twice a day) for 14 Days.
Arms:
Placebo
Other names:
Control
Size
30
Primary endpoint
Pulmonary Function
14 Days
Hypercapnic Ventilatory Response
14 Days
Sleep Quality
14 Days
Exercise Pulmonary Capacity
14 Days
Eligibility criteria
Inclusion Criteria: * Chronic high-level SCI (at least 24-months post injury) * Age 18 to 50 years. * Medically stable * Spinal Cord Injury ≥T3 * American Spinal Injury Association grade A or B or C. * Able to perform arm crank exercise. Exclusion Criteria: * Cardiomyopathy * High blood pressure( \>140/90 mmHg or you are taking high blood pressure medication) * Significant irregular heartbeat * Heart disease * Chronic lung disease (COPD, bronchitis) * Current use of cardioactive or antidepressant drugs * Family history of significant irregular heart beat or sudden cardiac death * Orthostatic hypotension (symptomatic fall in blood pressure \>30 mmHg when upright) * Current grade 2 or greater pressure ulcers at relevant contact site * Neurological disease (stroke, peripheral neuropathy, myopathy) * Arm or shoulder conditions that limit ability to perform arm crank exercise * History of bleeding disorder, diabetes, kidney disease, cancer, other neurological disease * Recent weigh change (greater than 10 pounds) * Regular use of tobacco * Intrathecal baclofen pump, * Current use of cardioactive, antidepressant, other sedating agents * Suicidal ideation * Pregnant and/or breastfeeding women. In addition, subjects must have no known hypersensitivity to Buspar and must not be taking a monoamine oxidase inhibitor.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-02-09

1 organization

1 product

1 drug

1 indication

Product
Buspirone