Trial intelligence / Profile preview

IBRF ACP/MCP Protocol in Severe Disorders of Consciousness

NCT02696512Phase 2

Key facts

Status: Unknown
Start: Mar 2016
Primary completion: Mar 2017
Countries: 1
Sponsor: International Brain Research Foundation
Modality: Allosteric Modulators, Orthosteric Ligands, Irreversible Covalent Inhibitors

Drugs: minocyclinelamotrigineflumazenilmodafinilbromocriptine
Conditions: disorders of consciousness (DoC)traumatic brain injury (TBI)

Overview

Phase 2, open-label trial of minocycline, lamotrigine, flumazenil, modafinil, bromocriptine and 9 more in disorders of consciousness (DoC) and traumatic brain injury (TBI) (2 arms), sponsored by International Brain Research Foundation. Primary endpoints: Tolerance to treatment at 12 weeks, Number and Frequency of side effects at 12 weeks and 1 more. Status: unknown.

Design

2 arms

Study design: Non-randomizedOpen-label

IBRF ACP/MCP Group 1
Polypharmacy, nutraceuticals, MNS, and Standard of Care
Standard of Care Group 2
Standard of Care only

Who it enrols

Patients aged 18-65 with severe disorders of consciousness (GCS 3-9) due to acquired brain injury, excluding those with tracheostomies requiring ventilator support, onset >12 months post HII or >24 months post TBI, terminal illnesses, severe neuro-developmental disorders, chronic degenerative neurological conditions, prior moderate-to-severe TBI, stroke syndrome other than TIA, prior seizure disorder, uncontrolled seizure disorder, and EF <25%.

Endpoints

Primary

Tolerance to treatment12 weeks
Number and Frequency of side effects12 weeks
Adverse events12 weeks

Secondary

Coma Recovery Scale-Revised12 weeks
Disability Rating Scale12 weeks
Functional Assessment Measure12 weeks
Glasgow Coma Scale12 weeks
Glasgow Outcome Scale-Extended12 weeks
Orientation Log12 weeks
Vegetative State12 weeks
Minimally Conscious State12 weeks

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