Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221689
Status:
TERMINATED
Last Update Posted:
2007-06-13
First Post:
2005-09-13
Brief Title:
Intrathecal Baclofen Therapy and Paroxysmal Dysautonomia in Severe Brain-Injured Patients
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Early Treatment of Paroxysmal Dysautonomia and Hypertonia for Severe Brain Injured Patients by Intrathecal Baclofen Therapy
Status:
TERMINATED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
very slow recruitment and treatments beyond expiry date
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Within the framework of a prospective double-blind and randomized study evaluating the efficacy of continuous intrathecal baclofen therapy CIBT on paroxysmal dysautonomia main objective and hypertonia recovery and tolerance secondary objectives during the initial recovery phase of severe head injury continuous intrathecal baclofen infusion will be delivered The first week of study is double-blind the first of two parallel groups receives CIBT and the second group receives placebo The main outcome number of neurovegetative episodes is assessed at the end of first week The second week of study is open labeled active treatment is continued in the first group and the second group starts active CIBT treatment The third week of study treatment is stopped in both groups
Detailed Description:
Background Severe brain trauma and especially serious brain lesions inducing coma lead to many cases of disability A large number of these patients about 30 present neurovegetative and hypertonic episodes that are associated to a bad vital prognosis and the degree of disability Several teams including two in France have reported the efficacy of intrathecal baclofen on such neurovegetative episodes that to date have not been able to be treated efficiently
Objectives The main objective of this trial is to assess the efficacy of infused intrathecal baclofen on the number of neurovegetative episodes in seriously brain-injured patients The secondary aims are to evaluate the efficacy of the treatment on hypertonia to assess changes in waking and treatment safety
Study design Double-blind randomized trial on two parallel groups The second part of the study is open label both groups receive the experimental treatment
Intervention
Experimental group continuous progressive dose of intrathecal baclofen for one week constant dose of baclofen during the second week receives at a dose determined after the first week Treatment is stopped after two weeks but patients are assessed until the end of the third week
Control group intrathecal placebo for one week progressive dose of intrathecal baclofen during the second week Treatment is stopped after two weeks but patients are assessed until the end of the third week
Outcomes The main outcome is the number of neurovegetative episodes in the last 48 hours of the first week of treatment Secondary outcomes are hypertonia as measured by the Ashworth scale on D2 to D5 of all three weeks Waking will be assessed by the WHIM scale on D5 each week Adverse events are assessed throughout the 3 weeks of study
Eligibility criteria Inclusion criteria are focal or diffuse encephalic lesions leading to coma Glasgow score 8 age 18 years or over in waking phase spontaneous eye-opening since at least one month and less than six months severe hypertonia of the lower members mean Ashworth score 3 with neurovegetative episodes at least 10 in 48 hours andor decortication after failure of treatment per os clonidine beta-blocker baclofen per os Non inclusion criteria are surgical anesthetic or allergic contraindication to baclofen uncontrolled sepsis directly threatening the implanted device or associated medullary trauma
Expected results Throughout the trial the patients will be hospitalized in the neurosurgical or neurological intensive care departments Expected results are a very clear decrease in the number of neurovegetative episodes and a substantial reduction in hypertonia at least in the lower limbs It will also be possible to quantify the consequences of these improvements on waking
Objectives The main objective of this trial is to assess the efficacy of infused intrathecal baclofen on the number of neurovegetative episodes in seriously brain-injured patients The secondary aims are to evaluate the efficacy of the treatment on hypertonia to assess changes in waking and treatment safety
Study design Double-blind randomized trial on two parallel groups The second part of the study is open label both groups receive the experimental treatment
Intervention
Experimental group continuous progressive dose of intrathecal baclofen for one week constant dose of baclofen during the second week receives at a dose determined after the first week Treatment is stopped after two weeks but patients are assessed until the end of the third week
Control group intrathecal placebo for one week progressive dose of intrathecal baclofen during the second week Treatment is stopped after two weeks but patients are assessed until the end of the third week
Outcomes The main outcome is the number of neurovegetative episodes in the last 48 hours of the first week of treatment Secondary outcomes are hypertonia as measured by the Ashworth scale on D2 to D5 of all three weeks Waking will be assessed by the WHIM scale on D5 each week Adverse events are assessed throughout the 3 weeks of study
Eligibility criteria Inclusion criteria are focal or diffuse encephalic lesions leading to coma Glasgow score 8 age 18 years or over in waking phase spontaneous eye-opening since at least one month and less than six months severe hypertonia of the lower members mean Ashworth score 3 with neurovegetative episodes at least 10 in 48 hours andor decortication after failure of treatment per os clonidine beta-blocker baclofen per os Non inclusion criteria are surgical anesthetic or allergic contraindication to baclofen uncontrolled sepsis directly threatening the implanted device or associated medullary trauma
Expected results Throughout the trial the patients will be hospitalized in the neurosurgical or neurological intensive care departments Expected results are a very clear decrease in the number of neurovegetative episodes and a substantial reduction in hypertonia at least in the lower limbs It will also be possible to quantify the consequences of these improvements on waking
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2001-009 | None | None | None |