Using Amantadine to Improve Consciousness in Patients
Amantadine for Neuroenhancement in Acute Patients Study - A Prospective Pilot Proof of Concept Phase IIb Study in Intensive and Intermediate Care Unit Patients
This study is testing if the medication Amantadine can help improve awareness in patients with reduced consciousness in the intensive care unit.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT05479032 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Amantadine on patients with reduced consciousness in intensive care settings. It is a monocenter, phase IIb, open-label pilot study involving 50 patients who will receive Amantadine treatment for 5 days. The study aims to assess improvements in vigilance using electroencephalography (EEG) and clinical tests such as the Glasgow Coma Scale (GCS) before, during, and after treatment. The primary goal is to determine if there is a significant improvement in GCS scores after the treatment period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with reduced consciousness not explained by other conditions.
Not a fit: Patients with consciousness levels that are not classified as reduced or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance consciousness and recovery outcomes for patients in critical care.
How similar studies have performed: While Amantadine has been used off-label with reported positive outcomes, scientific evidence is limited, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Must be ≥ 18 years at the time of signing the informed consent. * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures or informed consent is signed * As subject has per definition reduced consciousness and therefore is not in a position to provide written informed consent, inclusion of this patient is possible if the patient will give basic informed consent seven days after enrollment. Alternatively, the patient's relatives can give written informed consent. * Able to adhere to the study visit schedule and other protocol requirements. * Subject (male or female) is willing to use highly effective methods during treatment and for 4 days (male or female) after the end of treatment (adequate: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner1, sexual abstinence2). 1. Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success 2. In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. * All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment. * All subjects must agree not to share medication. * Reduced consciousness, defined as GCS \<8, not otherwise explained * Inconspicuous EEG and ECG Exclusion Criteria: * Women during pregnancy and lactation. * History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. * Participation in other clinical trials or observation period of competing trials. * Age \< 18 years * Reduced consciousness, otherwise sufficiently explained * Delirium (Intensive Care Delirium Screening Checklist (ICDSC) \> 4 or \>5 in aphasic patients) * History of epileptic seizures or status epilepticus * Pre-existing cardial conditions (e.g. heart failure (NYHA IV), cardiomyopathy, myocarditis, arrythmia (patients with a QTc time increase of \>60ms or interval of \>480ms have to be excluded from treatment), simultaneous treatment with other QT time elongating drugs, hypo-magnesaemia or -kalemia)
Where this trial is running
Tübingen
- Universitätsklinikum Tübingen — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Katharina Feil, attending physician — University Hospital Tübingen, Deparment for Neurology and Stroke
- Study coordinator: Katharina Feil, attending physician
- Email: katharina.feil@uni-tuebingen.de
- Phone: 07071/29-61753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.