AmantadinePhase 2DOC-AMSULNCT06443827
Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness
A Phase 2 study testing Amantadine Sulfate in people with Amantadine and Consciousness Disorders, run by Azienda Sanitaria dell'Alto Adige at 1 site in Italy.
Trial summary
Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness (unresponsive wakefulness syndrome and minimally conscious… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amantadine, Consciousness Disorders, Electroencephalography
- What is being tested?
- Amantadine Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2018to 30 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with disorders of consciousness due to acquired brain injury classified according to international guidelines based on CRS-R evaluation as unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) either in the subacute or chronic stage
Who cannot join
- Age < 18 years
- History of epileptic seizures/status epilepticus
- Scalp defects
- pregnancy
- Severe uncompensated heart failure (NYHA IV)
- Atrioventricular block (AV block) second-degree and third-degree
Show all 11Show fewer
- Known bradycardia (below 55 beats/minute)
- Known long QT interval (QTc according to Bazett > 420 ms
- History of serious ventricular arrhythmias
- Hypokalemia or hypomagnesemia
- Impaired renal function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intravenous Amantadine Sulphate on Brain Dynamics and Neurobehavioral Status in Patients With Disorders of Consciousness
Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness (unresponsive wakefulness syndrome and minimally conscious state) by integrating traditional neurobehavioral assessment with spectral analysis of electrocortical activity derived from 64-channel electroencephalography (EEG) recordings.
Read the detailed description
Research hypothesis Intravenous amantadine sulphate treatment (200 mg) over five days improves consciousness, defined as an increase in CRS-r score of at least 3 points, and changes the band powers of the EEG in patients with disorder of consciousness admitted in a Neurorehabilitation Department.
- Conditions
- Amantadine, Consciousness Disorders, Electroencephalography
- Being tested
- Amantadine Sulfate
- Keywords
- DoC = Disorders of Consciousness, PSD = Power Spectral Density, Amantadine sulphate, EEG
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amantadine SulfateDrug
Also called physiological saline (0.9% NaCl solution)
intravenous amantadine sulphate at a single daily dose of 200 mg or physiological saline (0.9% NaCl solution)
| Study group | Role | What they receive |
|---|---|---|
| amantadine sulphate and placebo with schema A-B-A-B | Experimental | To obtain solid evidence of amantadine sulphate effects and their temporal dynamics, we conducted a double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2). Receives: Drug: Amantadine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-Revised (CRS-R)
Increase in the Coma Recovery Scale-Revised (CRS-R) score of at least 1 point. The CRS-R consists of 23 items divided into six subscales designed to assess: Auditory (AU), Visual (V), Motor (M), Oromotor/Verbal (O), Communication (C), and Arousal functions (AR).
The total score ranges between 0 (worst) and 23 (best). The subscales are composed of hierarchically ordered items; the lowest items (0) represent reflexive activity, while the highest items (4,5,6,3,2,3 points for AU, V, M, O, C respectively) represent cognitively mediated behaviours. We adopted a cut-off score of 8 for distinguish UWS/VS (<8) from MCS (≥8) in patients induced by amantadine sulphate vs. placebo
Measured: days 14 and 28
EEG band power alpha, beta, theta, delta
Change in each canonical band power of EEG induced by amantadine sulphate
Measured: days 14 and 28
Secondary outcomes (1)
"periodic" and "aperiodic" exponents of the average power spectral density
Change in "periodic" and "aperiodic" exponents of the average power spectral density vs. placebo and vs healthy controls
Measured: days 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start15 Sep 2018
- Primary completion10 Jan 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmantadineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria dell'Alto Adige
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Versace, Azienda Sanitaria dell'Alto Adige
- Investigators
- Viviana Versace, MD, Principal investigator, hospital of Vipiteno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443827
- Sponsor's protocol ID
- 39049
- Acronym
- DOC-AMSUL
- Status last verified
- Nov 2025
- First submitted
- 15 May 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Amantadine Sulphate on Brain Dynamics and Neurobehavioral Status in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06443827
- Acronym / sponsor ID
- DOC-AMSUL / 39049
- Conditions
- Amantadine, Consciousness Disorders, Electroencephalography
- Keywords
- DoC = Disorders of Consciousness, PSD = Power Spectral Density, Amantadine sulphate, EEG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Azienda Sanitaria dell'Alto AdigeUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness (unresponsive wakefulness syndrome and minimally conscious state) by integrating traditional neurobehavioral assessment with spectral analysis of electrocortical activity derived from 64-channel electroencephalography (EEG) recordings.
Detailed description
Research hypothesis Intravenous amantadine sulphate treatment (200 mg) over five days improves consciousness, defined as an increase in CRS-r score of at least 3 points, and changes the band powers of the EEG in patients with disorder of consciousness admitted in a Neurorehabilitation Department.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2).
| Arm | Type | Receives |
|---|---|---|
| amantadine sulphate and placebo with schema A-B-A-B | Experimental | Drug: Amantadine SulfateTo obtain solid evidence of amantadine sulphate effects and their temporal dynamics, we conducted a double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with disorders of consciousness due to acquired brain injury classified according to international guidelines based on CRS-R evaluation as unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) either in the subacute or chronic stage
Key exclusion criteria (11 listed)
- Age < 18 years
- History of epileptic seizures/status epilepticus
- Scalp defects
- pregnancy
- Severe uncompensated heart failure (NYHA IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amantadine SulfateAlso: physiological saline (0.9% NaCl solution)intravenous amantadine sulphate at a single daily dose of 200 mg or physiological saline (0.9% NaCl solution) | Drug | amantadine sulphate and placebo with schema A-B-A-B |
Primary outcome
Coma Recovery Scale-Revised (CRS-R)
Time frame: days 14 and 28
Increase in the Coma Recovery Scale-Revised (CRS-R) score of at least 1 point. The CRS-R consists of 23 items divided into six subscales designed to assess: Auditory (AU), Visual (V), Motor (M), Oromotor/Verbal (O), Communication (C), and Arousal functions (AR). The total score ranges between 0 (worst) and 23 (best). The subscales are composed of hierarchically ordered items; the lowest items (0) represent reflexive activity, while the highest items (4,5,6,3,2,3 points for AU, V, M, O, C respectively) represent cognitively mediated behaviours. We adopted a cut-off score of 8 for distinguish UWS/VS (<8) from MCS (≥8) in patients induced by amantadine sulphate vs. placebo
EEG band power alpha, beta, theta, delta
Time frame: days 14 and 28
Change in each canonical band power of EEG induced by amantadine sulphate
1 secondary outcome
"periodic" and "aperiodic" exponents of the average power spectral density
Time frame: days 14 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viviana Versace, MD principal investigator
hospital of Vipiteno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amantadine Sulfate in people with Amantadine and Consciousness Disorders, run by Azienda Sanitaria dell'Alto Adige at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale-Revised (CRS-R) (time frame: days 14 and 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.