Acute Disseminated EncephalomyelitisPhase 3NCT00004645
Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
A Phase 3 study testing Plasma exchange in people with Acute Disseminated Encephalomyelitis and Devic's Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS).
Trial summary
OBJECTIVES: I. Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of inflammatory demyelinating disease in patients who have failed intravenous steroid therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Disseminated Encephalomyelitis, Devic's Syndrome, Marburg's Variant of Multiple Sclerosis
- What is being tested?
- Plasma exchange
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 1995to not given
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Idiopathic inflammatory demyelinating syndrome, as follows: biopsy-proven if necessary - established diagnosis of multiple sclerosis (MS) using Poser criteria; acute disseminated encephalomyelitis; Marburg's variant of MS Balo's concentric sclerosis
- Eligible without biopsy: acute transverse myelitis; Devic's syndrome
- Acute neurologic deficit markedly affecting consciousness, language, or brainstem/spinal cord function, i.e., aphasia, paraplegia, coma, quadriplegia, hemiplegia, severe organic brain syndrome
- Deficit unresponsive to 5 days of high-dose intravenous methylprednisolone (MePRDL), as follows: deficit duration of 21 days to 3 months AND no improvement 14 days after beginning MePRDL OR deficit duration of 12 to 20 days AND continued deterioration after completion of MePRDL
- No chronically progressive demyelinating disease
- No HIV-associated demyelinating syndrome
- No progressive multifocal leukoencephalopathy
- No optic neuritis
--Prior/Concurrent Therapy--
- No more than 3 months of prior steroid therapy Failure on prior MePRDL required Minimum dose 7 mg/kg per day for 5 days
- At least 6 weeks since other immunosuppressives, e.g., cyclophosphamide, azathioprine, cyclosporine
--Patient Characteristics--
- Renal: Creatinine less than 1.5 mg/dL
- Cardiovascular: No hypovolemia; no infarction; no vasculitis; no other major systemic cardiovascular illness
- Pulmonary: No major respiratory illness
- Other: No infection, including hepatitis or human immunodeficiency virus; no recent intravenous drug abuse; no high-risk sexual behavior; no cardiac, cerebrovascular, or autonomic dysfunction that would increase risk of hypotension; no other major systemic illness that would preclude protocol therapy; no pregnant or nursing women; negative serum pregnancy test required of fertile women; effective contraception required
About this study
OBJECTIVES:
- Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by disease type; each stratum is randomized separately.
The first group of patients receives a true plasma exchange using continuous-flow centrifugation with serum albumin and crystalloid replacement every 2 days for a total of 7 exchanges.
The second group receives a sham plasma exchange with no centrifugation every 2 days for a total of 7 exchanges.
Patients cross to the alternate therapy if there is less than a moderate improvement by day 14. The treatment decision is based on a blinded neurologic assessment.
Concurrent corticosteroids and other immunosuppressants, and high-dose barbiturates are not allowed.
Patients are followed at 1 and 6 months after the last exchange.
- Conditions
- Acute Disseminated Encephalomyelitis, Devic's Syndrome, Marburg's Variant of Multiple Sclerosis, Balo's Concentric Sclerosis, Acute Transverse Myelitis
- Being tested
- Plasma exchange
- Keywords
- Balo's concentric sclerosis, Devic's syndrome, Marburg's variant of multiple sclerosis, acute disseminated encephalomyelitis, acute transverse myelitis, multiple sclerosis, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Encephalomyelitis, Acute Disseminated, Neuromyelitis Optica, Diffuse Cerebral Sclerosis of Schilder, Myelitis, Transverse, Multiple Sclerosis, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchangeProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startJan 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Disseminated EncephalomyelitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Mayo Clinic
- Investigators
- Brian G. Weinshenker, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004645
- Sponsor's protocol ID
- 199/11693
- Other IDs
- MAYOC-29493
- Status last verified
- Mar 1999
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-Blind, Sham-Controlled Study of Plasma Exchange for Acute Severe Attacks of Inflammatory Demyelinating Disease Refractory to Intravenous Methylprednisolone
- ClinicalTrials.gov ID
- NCT00004645
- Acronym / sponsor ID
- 199/11693
- Conditions
- Acute Disseminated Encephalomyelitis, Devic's Syndrome, Marburg's Variant of Multiple Sclerosis, Balo's Concentric Sclerosis, Acute Transverse Myelitis
- Keywords
- Balo's concentric sclerosis, Devic's syndrome, Marburg's variant of multiple sclerosis, acute disseminated encephalomyelitis, acute transverse myelitis, multiple sclerosis, neurologic and psychiatric disorders, rare disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Mayo Clinic
- Study start
- Jan 1995
- First posted
- 25 Feb 2000 (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.
OBJECTIVES:
- Evaluate the effectiveness of plasma exchange in the treatment of acute severe attacks of inflammatory demyelinating disease in patients who have failed intravenous steroid therapy.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by disease type; each stratum is randomized separately.
The first group of patients receives a true plasma exchange using continuous-flow centrifugation with serum albumin and crystalloid replacement every 2 days for a total of 7 exchanges.
The second group receives a sham plasma exchange with no centrifugation every 2 days for a total of 7 exchanges.
Patients cross to the alternate therapy if there is less than a moderate improvement by day 14. The treatment decision is based on a blinded neurologic assessment.
Concurrent corticosteroids and other immunosuppressants, and high-dose barbiturates are not allowed.
Patients are followed at 1 and 6 months after the last exchange.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Plasma exchange | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Brian G. Weinshenker study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plasma exchange in people with Acute Disseminated Encephalomyelitis and Devic's Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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.
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 24 Jun 2005.