Multiple SclerosisPhase 2ACTHNCT00986960
Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in Patients With Relapsing Remitting Multiple Sclerosis (MS)
A Phase 2 study testing repository corticotropin injection and Saline in people with Multiple Sclerosis, run by University at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- repository corticotropin injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with MS according to McDonald criteria
- Age 18-65
- Have a RR disease course
- Have EDSS scores 0-5.5
- Have a disease duration <20 years
- Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:
Show all 11Show fewer
- presence of a documented relapse within the last 12 months
- or the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
- Signed informed consent
- Normal kidney functioning (creatinine clearance >59)
- None of the exclusion criteria
Who cannot join
- Presence of relapse or steroid treatment within 60 days prior to study enrollment
- Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment
- Presence of optic neuritis within less than 6 months prior to study enrollment
- Diagnosis of osteoporosis (T score ≥2.5 SD)
- Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
- Abnormal blood tests, performed during the screening visit including: hepatitis B or hepatitis C, ALT or AST greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
- History of depression while on IFNβ-1a I.M.
Trial locations and contacts
1 site in 1 country.
United States1 site
University at Buffalo, Buffalo General Hospital
Buffalo, New York, 14203
About this study
Official title: Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study
The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.
Read the detailed description
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.
- Conditions
- Multiple Sclerosis
- Being tested
- repository corticotropin injection, Saline
- Keywords
- multiple sclerosis, relapsing remitting, RRMS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repository corticotropin injectionDrug
Also called H.P. Acthar gel
IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
SalineDrug
I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Adrenocorticotropin hormone | Active comparator | Patients receive the hormone Receives: Drug: repository corticotropin injection |
| Placebo | Placebo comparator | Patients receive placebo only Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS
Effect of ACTH in MRI
Measured: 1 year
Secondary outcomes (1)
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS.
Effect of ACTH on optic health
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2010
- Study completionDec 2010
Why it stopped: Difficult to recruit due to protocol requirements - participant burden.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Zivadinov, MD, PhD, University at Buffalo
- Investigators
- Robert Zivadinov, MD, PhD, Principal investigator, Buffalo Neuroimaging Analysis CenterBianca Weinstock-Guttman, MD, Principal investigator, Jacobs Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986960
- Sponsor's protocol ID
- NDA 08-372
- Other IDs
- NDA 08-372
- Acronym
- ACTH
- Status last verified
- Dec 2020
- First submitted
- 29 Sep 2009
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study
- ClinicalTrials.gov ID
- NCT00986960
- Acronym / sponsor ID
- ACTH / NDA 08-372
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, relapsing remitting, RRMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult to recruit due to protocol requirements - participant burden.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Sep 2009 (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.
The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.
Detailed description
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenocorticotropin hormone | Active comparator | Drug: repository corticotropin injectionPatients receive the hormone |
| Placebo | Placebo comparator | Drug: SalinePatients receive placebo only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient diagnosed with MS according to McDonald criteria
- Age 18-65
- Have a RR disease course
- Have EDSS scores 0-5.5
- Have a disease duration <20 years
Key exclusion criteria (7 listed)
- Presence of relapse or steroid treatment within 60 days prior to study enrollment
- Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment
- Presence of optic neuritis within less than 6 months prior to study enrollment
- Diagnosis of osteoporosis (T score ≥2.5 SD)
- Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
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 |
|---|---|---|
| repository corticotropin injectionAlso: H.P. Acthar gelIM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months | Drug | Adrenocorticotropin hormone |
| SalineI.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months. | Drug | Placebo |
Primary outcome
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS
Time frame: 1 year
Effect of ACTH in MRI
1 secondary outcome
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS.
Time frame: 1 year
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 Jan 2021.
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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.
Robert Zivadinov, MD, PhD principal investigator
Buffalo Neuroimaging Analysis Center
Bianca Weinstock-Guttman, MD principal investigator
Jacobs Neurological Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing repository corticotropin injection and Saline in people with Multiple Sclerosis, run by University at Buffalo at 1 site in United States.
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 11 inclusion and 7 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 Jan 2021. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS (time frame: 1 year). 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 Jan 2021.