Zolpidem to treat disorders of consciousness

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

ZOLPIDEM AROUSING EFFECT IN PERSISTENT VEGETATIVE STATE PATIENTS: AUTONOMIC, EEG AND BEHAVIORAL ASSESSMENT

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Institute of Neurology and Neurosurgery "Prof. Rafael Estrada Gonzalez"

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Calixto Machado, Specialist in Neurology and Clinical Neurophysiology, PhD, Senior Professor and Researcher

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Research ethics committees:

Ethics Committee, 14-10-2010

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

03/01/2011

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Persistent vegetative state (PVS) patients

Intervention(s):

Study group (Zolpidem): 10mg dose of Zolpidem. Zolpidem tablets were cracked and duly mixed with 15 ml of cherry syrup. Single dose by oral route for healthy volunteers; and by percutaneous endoscopic gastrostomies route for patients. Control group (Placebo): 10mg sucrose + 30 mg of inert solid excipient. Single dose by oral route for healthy volunteers and by percutaneous endoscopic gastrostomies route for patients. Every participant received the two interventions by random list. The second intervention was received 7 days after the first.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

JFK Coma Recovery Scale-Revised (CRS-R). Measuring time: before and after each administration. Autonomic variables (heart variability indices calculated for time and frequency dominium). Measuring time: during 20 minutes (basal record), and during 120 minutes after each administration. EEG (percent of activated and non-activated EEG segments). Measuring time: during 20 minutes (basal record), and during 120 minutes after each administration.

Key secondary outcomes:

Not applicable

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

16 years

Maximum age:

N/A (No limit)

Inclusion criteria:

Inclusion criteria for patients •Persistent vegetative state patients were diagnosed according to current diagnostic criteria from the American Academy of Neurology • Patients showed eye movements with lack of fixation, no evidence of awareness of self or environment, lack of interaction with others, and no comprehension or expression of language. •Patients with an age no less than 16 years old •One month at least of clinical evolution Inclusion criteria for control normal subjects •Normal subjects, matched in sex and age with patients •Normal subjects did not have a history of any neurological or other chronic diseases, and they were not under any medication. •No history of being under medication such asr Zolpidem or a related benzodiazepine medication •Willingness to participate in the protocol

Exclusion criteria:

Exclusion criteria for patients •Patients who evidence of awareness of self or environment, some cognitive function, and interaction with others. •Patients with less than 16 years old •Less than one month of clinical evolution •Patients with the Diabetes Mellitus, or other systemic disease affecting the autonomic system Exclusión criteria for normal control subjects •Younger than 16 years old •Diagnosis of neurological, cardiologic, or other systemic diseases, •Presence de signs electrocardiographic signs of ischemia or arrhythmia •Being under the use of zolpidem, or other benzodiazepine drugs. •No willingness of participating in the protocol

Type of population:

Not entered

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Not entered

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Other

Other design:

N/A

Phase:

Not entered

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Calixto

Last Name:

Machado-Curbelo

Affiliation:

Institute of Neurology and Neurosurgery "Prof. Rafael Estrada Gonzalez"

Postal Address:

29 y D, Vedado

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

537-834 5578

Email :

braind@infoemed.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Not entered

Last Name:

Not entered

Affiliation:

Not entered

Postal Address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email :

email@not.entered [1]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000151

Date of Registration in Primary Registry:

2013-03-21

Record Verification Date:

2013-03-18 20:00

Link to the spanish version:

Click here [3]