Effect of Adrenocorticotropin Injection With Weekly Interferon Beta in
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
What it found
The trial ended early for another reason (see below).
Reason given: Difficult to recruit due to protocol requirements - participant burden.
What was tested
Treatment tested
- Corticotropin
Melanocortin receptor 2 agonist
Placebo
- Saline
What it measured
Main measures
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
1 year
MRI lesionsMyelin repair
Other measures (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.
1 year
Retina scans (OCT)
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
* 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: * 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
Exclusion criteria
* 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Dec 2009
Main results due
Sept 2010
Finished
Dec 2010