Trial · NCT00970944

Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)

NCT00970944, Phase 2, Phase 3, Completed, JFK Medical Center; results first posted 2012-09-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI). Trials, record NCT00970944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00970944

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness of Amantadine Hydrochloride for Treatment of Severe Traumatic Brain Injury (TBI)
NCT number: NCT00970944
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 184 participants, actual
Lead sponsor: JFK Medical Center
Conditions: Traumatic Brain Injury
Interventions: Amantadine Hydrochloride, Placebo
First posted: 2009-09-03
Last updated: 2012-09-24
Results first posted: 2012-09-24

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disability Rating Scale: Functional Status	Randomization and weekly for 6 weeks. The primary study endpoint was week 4 and drug washout was week 6.	Measure of function after traumatic brain injury (TBI) intended to measure function from "coma to community." Minimum score= 0; Maximum score= 29 (High scores are indicative of greater degree of disability).
Secondary	JFK Coma Recovery Scale-Revised: Neurobehavioral Status	Week 4 (primary endpoint); Week 6 (post-washout)	Measure of neurobehavioral function and clinical change for individuals with severe alterations of consciousness. Minimum score= 0; Maximum score= 23 (Higher scores are indicative of a higher-level of neurobehavioral function).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	JFK Coma Recovery Scale-Revised: Neurobehavioral Status	Week 4 (primary endpoint); Week 6 (post-washout)	Analyses were conducted according to the ITT principle so that all 184 patients randomized were included for analysis. Imputation techniques were not undertaken since missing data were infrequent and unrelated to study outcome.	units on a scale	MEAN
PRIMARY	Disability Rating Scale: Functional Status	Randomization and weekly for 6 weeks. The primary study endpoint was week 4 and drug washout was week 6.	Analyses were conducted according to the intention-to-treat principle. 184 subjects were randomized and included for analysis. Since missing data were infrequent and unrelated to the study outcome, imputation methods were not undertaken.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
JFK Coma Recovery Scale-Revised: Neurobehavioral Status	Amantadine	Week 4 (Primary endpoint)	15.8	Standard Deviation 6.1	units on a scale
JFK Coma Recovery Scale-Revised: Neurobehavioral Status	Placebo	Week 4 (Primary endpoint)	14.2	Standard Deviation 6.6	units on a scale
JFK Coma Recovery Scale-Revised: Neurobehavioral Status	Amantadine	Week 6 (Post-washout)	15.7	Standard Deviation 6.3	units on a scale
JFK Coma Recovery Scale-Revised: Neurobehavioral Status	Placebo	Week 6 (Post-washout)	15.1	Standard Deviation 6.8	units on a scale
Disability Rating Scale: Functional Status	Amantadine	Week 4 (Primary endpoint)	17.3	Standard Deviation 4.7	units on a scale
Disability Rating Scale: Functional Status	Placebo	Week 4 (Primary endpoint)	18.7	Standard Deviation 4.5	units on a scale
Disability Rating Scale: Functional Status	Amantadine	Week 6 (Drug washout)	17.1	Standard Deviation 5.2	units on a scale
Disability Rating Scale: Functional Status	Placebo	Week 6 (Drug washout)	17.8	Standard Deviation 5.3	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Amantadine HCL	87
Overall Study	STARTED	Placebo	97
Overall Study	COMPLETED	Amantadine HCL	86
Overall Study	COMPLETED	Placebo	95
Overall Study	NOT COMPLETED	Amantadine HCL	1
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypertonia / Spasticity	Musculoskeletal and connective tissue disorders	Amantadine HCL	18	87	21
other	Hypertonia / Spasticity	Musculoskeletal and connective tissue disorders	Placebo	14	97	18
other	Insomnia / Sleep Disturbance	General disorders	Amantadine HCL	12	87	14
other	Insomnia / Sleep Disturbance	General disorders	Placebo	14	97	15
other	Agitation / Aggression	Psychiatric disorders	Amantadine HCL	12	87	16
other	Agitation / Aggression	Psychiatric disorders	Placebo	11	97	14
other	Infections	Infections and infestations	Amantadine HCL	10	87	14
other	Infections	Infections and infestations	Placebo	15	97	16
other	Urinary tract infection	Renal and urinary disorders	Amantadine HCL	13	87	15
other	Urinary tract infection	Renal and urinary disorders	Placebo	12	97	13

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Amantadine HCL
Total, all-cause mortality	Placebo
Total, other adverse events	Amantadine HCL	54	87
Total, other adverse events	Placebo	51	97
Total, serious adverse events	Amantadine HCL	15	87
Total, serious adverse events	Placebo	19	97

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22375973	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Amantadine HCL vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00970944

GET https://conductscience.org/api/trials/v1/NCT00970944/events?page=2

API reference For AI assistants