Effects of Baclofen on Presynaptic Inhibition in Humans

NCT04471714 | Withdrawn Phase 2 DMC

• 1 other identifier: Pro00090588
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the role of the GABA-B receptor in long-lasting presynaptic inhibition of primary afferents in human participants. Participants will come in for two visits, receiving baclofen (a GABA-B receptor agonist) on one visit and a placebo during the other. Electro-physiological measures will be use during both visit to asses presynaptic inhibition.

Conditions

Spasticity, Muscle; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• The effects of baclofen (GABA-B) on Presynaptic Inhibition of primary afferents

  Our primary objective is to determine how activation of GABA-B receptors control transmission of sensory afferents as measured by the H-reflex.

  1 year

Study Arms (2)

Control

EXPERIMENTAL

Control participants will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other.

Drug: Baclofen

Spinal Cord Injury

EXPERIMENTAL

Participants with a spinal cord injury will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other.

Drug: Baclofen

Interventions

Baclofen DRUG

Participants will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other. During each visit the soleus H-reflex will be measured and conditioned by common peroneal nerve stimulation to assess presynaptic inhibition.

Also known as: Placebo

Control; Spinal Cord Injury

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults between the ages of 18 and 65 years.
• General good health

You may not qualify if:

• Contraindications to baclofen such as a known hypersensitivity to baclofen, renal impairment, stroke, epilepsy, pregnancy and lactation.
• Injury to peripheral nerves or muscles. Injury to nerves or muscles will confound the interpretation of the spinal reflex data.
• Participants with spinal cord injury already taking oral baclofen to manage spasticity.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

524 HMRC, University of Alberta

Edmonton, Alberta, T6G2R3, Canada

Location

MeSH Terms

Conditions

Muscle Spasticity; Spinal Cord Injuries

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Monica Gorassini, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and researchers will be blinded. The research technician will be not be blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a double blinded, cross-over, retrospective cohort design where the size of the H-reflex and motor unit firing rates will be examined before and after oral intake of baclofen or placebo.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 15, 2020
• Study Start: January 10, 2020
• Primary Completion: March 17, 2022
• Study Completion: March 17, 2022
• Last Updated: September 19, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon completion of the study (TBD).
• Access Criteria: IPD will be provided to researchers who have contacted the primary investigator and requested additional data. All data will be de-identified.

Locations

CA (1)