Neurotoxicity SyndromesNCT00389259
Scopolamine Treatment for Patients With Organophosphate Poisoning
A study of Neurotoxicity Syndromes, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a common cause of death among people who commit suicide in developing countries. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Neurotoxicity Syndromes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Dec 2009
- Phase
- Interventional
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: 2- 60 years
- At least two of the following three criteria:
- Known exposure to an organophosphate or carbamate insecticide in the last 72 hours.
- Symptoms and signs typical to organophosphate poisoning involving at least two systems (gastrointestinal, respiratory, skin, eyes,) See appendix
- Low levels of plasma butyrylcholinesterase (less than 50% of the lower normal range )
- CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria
Show all 14Show fewer
- Major criteria for CNS involvement:
- Seizures
- Extrapyramidal or Parkinson like symptoms
- Decreased level of consciousness (GCS< 12)
- Minor criteria for CNS involvement:
- GCS 14-12
- Confusion
- Hallucinations
Who cannot join
- Hypersensitivity to scopolamine
- Glaucoma, narrow-angle (angle-closure)
- Tachyarrhythmias, congestive heart failure
- Obstructive gastrointestinal disease
- Myasthenia Gravis
- Reflux esophagitis
Show all 11Show fewer
- Ulcerative colitis
- Known obstructive uropathy
- Pregnancy
- Patient or legal guardian unable to give informed consent (see comment under ethics)
- Severe co-morbidity (multi-trauma, advanced cancer, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scopolamine Treatment for Patients With Organophosphate Poisoning - a Randomized, Double Blind, Placebo-Controlled Study.
Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a common cause of death among people who commit suicide in developing countries. OPs poisoning also frequently occurs after accidental exposure to agricultural OPs and in children as a result of unintentional ingestion.
The use of competitive inhibitors of acetylcholine other than atropine for patient with organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the blood brain barrier is better than atropine, it has been suggested that scopolamine should be used OP poisoned patients who have central nervous system (CNS) manifestations. However there is controversy regarding its potential benefit in the treatment of organophosphate poisoning in humans. To the best of our knowledge there are no randomised controlled studies on the use of scopolamine in humans. This prospective randomised controlled study is aimed to determine whether adding scopolamine to the standard treatment of atropine and oximes in patients with CNS symptoms of OP poisoning improve the outcome.
Read the detailed description
Objective: to determine whether adding scopolamine to the standard treatment of atropine and oximes improve the outcome of patients with OP poisoning and CNS manifestations. Design: A multi-center, randomized, double blind, placebo controlled study. Setting: Emergency Departments \& Intensive Care Units in Israel. Participants: Patients 2 -60 years old with acute OP poisoning and CNS manifestations. Interventions: In addition to standard treatment with atropine and obidoxime, eligible patients will be randomly assigned to one of two treatment groups, scopolamine group, and placebo group (both given in the same volume). Scopolamine will be given IM or IV in a dose of 0.25mg for adults and 0.006mg/kg for children every 4 hours. At least three doses of scopolamine (or placebo) will be given. The medical staff will be blinded to the treatment given. Main outcome measures: Improvement in neurological status, duration of seizures and number of days on ventilator. Data analysis: The main outcome measures, will be compared using the Student's t-test or the Mann-Whitney tests as appropriate. The *2 or Fisher Exact tests, as appropriate, will be used for comparisons of categorical variables. We will use multiple logistic regression to examine the extent to which variables predict success or failure of the treatment.
- Conditions
- Neurotoxicity Syndromes
- Being tested
- Placebo
- Keywords
- Insecticides, Organophosphate, Scopolamine, randomized control study, Organophosphate or carbamate intoxication
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
IV placebo q4h
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | IV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h Receives: Drug: Placebo |
| B | Placebo comparator | IV Look alike drug Q 4h Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in neurological status as measured by the Glasgow Coma Scale
Measured: 1 week
Duration of seizures.
Measured: 1 week
Number of days on ventilator
Measured: 1 week
Secondary outcomes (10)
Total cumulative dose of atropine
Measured: 1 week
Need for benzodiazepines
Measured: 1 week
Number of days in the ICU
Measured: 2 weeks
Adverse effects and complications
Measured: 2 weeks
Neurological assessment at discharge
Measured: 2 weeks
Neurological assessment 3 month after the exposure
Measured: 3 month
Neuro-cognitive assessment at 3 month
Measured: 3 month
Survival at 24 hours
Measured: 24 hours
Survival to discharge
Measured: 4 weeks
Number of days in hospital
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startOct 2007
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotoxicity SyndromesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Israeli MOH, International Diabetes Federation
- Investigators
- Eran Kozer, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389259
- Sponsor's protocol ID
- 70/04*1
- Status last verified
- Mar 2010
- First submitted
- 17 Oct 2006
- Last updated
- 5 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scopolamine Treatment for Patients With Organophosphate Poisoning - a Randomized, Double Blind, Placebo-Controlled Study.
- ClinicalTrials.gov ID
- NCT00389259
- Acronym / sponsor ID
- 70/04*1
- Conditions
- Neurotoxicity Syndromes
- Keywords
- Insecticides, Organophosphate, Scopolamine, randomized control study, Organophosphate or carbamate intoxication
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Israeli MOH, International Diabetes Federation
- Study start
- Oct 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 18 Oct 2006 (estimated)
- 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.
Organophosphate (OP) compounds are a major threat as chemical warfare agents or in terrorist act. OPs are also the active ingredient of many insecticides. Ingestion of insecticides is a common cause of death among people who commit suicide in developing countries. OPs poisoning also frequently occurs after accidental exposure to agricultural OPs and in children as a result of unintentional ingestion.
The use of competitive inhibitors of acetylcholine other than atropine for patient with organophosphate (OP) poisoning is controversial. Because scopolamines' ability to cross the blood brain barrier is better than atropine, it has been suggested that scopolamine should be used OP poisoned patients who have central nervous system (CNS) manifestations. However there is controversy regarding its potential benefit in the treatment of organophosphate poisoning in humans. To the best of our knowledge there are no randomised controlled studies on the use of scopolamine in humans. This prospective randomised controlled study is aimed to determine whether adding scopolamine to the standard treatment of atropine and oximes in patients with CNS symptoms of OP poisoning improve the outcome.
Detailed description
Objective: to determine whether adding scopolamine to the standard treatment of atropine and oximes improve the outcome of patients with OP poisoning and CNS manifestations. Design: A multi-center, randomized, double blind, placebo controlled study. Setting: Emergency Departments \& Intensive Care Units in Israel. Participants: Patients 2 -60 years old with acute OP poisoning and CNS manifestations. Interventions: In addition to standard treatment with atropine and obidoxime, eligible patients will be randomly assigned to one of two treatment groups, scopolamine group, and placebo group (both given in the same volume). Scopolamine will be given IM or IV in a dose of 0.25mg for adults and 0.006mg/kg for children every 4 hours. At least three doses of scopolamine (or placebo) will be given. The medical staff will be blinded to the treatment given. Main outcome measures: Improvement in neurological status, duration of seizures and number of days on ventilator. Data analysis: The main outcome measures, will be compared using the Student's t-test or the Mann-Whitney tests as appropriate. The *2 or Fisher Exact tests, as appropriate, will be used for comparisons of categorical variables. We will use multiple logistic regression to examine the extent to which variables predict success or failure of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PlaceboIV Scopolamine 0.25mg in adults and 0.006mg/kg in children Q4h |
| B | Placebo comparator | Drug: PlaceboIV Look alike drug Q 4h |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Age: 2- 60 years
- At least two of the following three criteria:
- CNS involvement in the first 72 hours after exposure: determined by finding at least one of the following major criteria or at least two of the minor criteria
- Seizures
- Extrapyramidal or Parkinson like symptoms
Key exclusion criteria (11 listed)
- Hypersensitivity to scopolamine
- Glaucoma, narrow-angle (angle-closure)
- Tachyarrhythmias, congestive heart failure
- Obstructive gastrointestinal disease
- Myasthenia Gravis
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 |
|---|---|---|
| PlaceboIV placebo q4h | Drug | A, B |
Primary outcome
Improvement in neurological status as measured by the Glasgow Coma Scale
Time frame: 1 week
Duration of seizures.
Time frame: 1 week
Number of days on ventilator
Time frame: 1 week
10 secondary outcomes
Total cumulative dose of atropine
Time frame: 1 week
Need for benzodiazepines
Time frame: 1 week
Number of days in the ICU
Time frame: 2 weeks
Adverse effects and complications
Time frame: 2 weeks
Neurological assessment at discharge
Time frame: 2 weeks
Neurological assessment 3 month after the exposure
Time frame: 3 month
Neuro-cognitive assessment at 3 month
Time frame: 3 month
Survival at 24 hours
Time frame: 24 hours
Survival to discharge
Time frame: 4 weeks
Number of days in hospital
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2011.
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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.
Eran Kozer, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Neurotoxicity Syndromes, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 14 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: withdrawn, as of the sponsor's last update on 5 Apr 2011. 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 Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in neurological status as measured by the Glasgow Coma Scale (time frame: 1 week). The study lists 3 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 5 Apr 2011.