Optic NeuritisEarly Phase 1ACHTARNCT01987167
Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis
A Early Phase 1 study testing ACTHAR in people with Optic Neuritis, run by Neuro-Ophthalmologic Associates, PC at 1 site in United States.
Trial summary
The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- ACTHAR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2016
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral acute demyelinating optic neuritis
- Able to provide informed consent
- age 18 or older
- can perform the above listed electrophysiologic diagnostic testing
- can perform high and low contrast visual acuity and visual field perimetry
Who cannot join
- prior diagnosis of remitting/relapsing multiple sclerosis(RRMS)
- secondary progressive MS(SPMS)
- primary progressive MS (PPMS)
- undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination)
- prior diagnosis of systemic lupus erythematosis
- mixed connective tissue disease
Show all 9Show fewer
- vasculitis
- sarcoidosis
- neuro-myelitis optica
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuro Ophthalmology
Philadelphia, Pennsylvania, 19107
About this study
Official title: Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis
The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Read the detailed description
Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
- Conditions
- Optic Neuritis
- Being tested
- ACTHAR
- Keywords
- acute optic neuritis
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTHARDrug
Also called Repository Corticotropin
Injectable Gel
| Study group | Role | What they receive |
|---|---|---|
| -ACHTHAR | Experimental | Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU Receives: Drug: ACTHAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuro-protection
Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.
Measured: 12 months
Secondary outcomes (1)
Preservation of retinal nerve fiber layer.
To define the objective (micron thickness, volumetric analysis) and subjective (histopathological changes) of spectral domain optical coherence tomography (SD-OCT) at the time of clinical presentation of acute optic neuritis and during 6 months of recovery following ACTHAR treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic NeuritisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuro-Ophthalmologic Associates, PC
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Robert C Sergott, M.D., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987167
- Sponsor's protocol ID
- 13-330
- Other IDs
- ACTHAR
- Acronym
- ACHTAR
- Status last verified
- Aug 2017
- First submitted
- 6 Nov 2013
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Moster ML, Sergott RC, Leiby BE. Dalfampridine Treatment in Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2017 Sep;37(3):348-349. doi: 10.1097/WNO.0000000000000523. No abstract available.
PubMed 28538037
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis
- ClinicalTrials.gov ID
- NCT01987167
- Acronym / sponsor ID
- ACHTAR / 13-330
- Conditions
- Optic Neuritis
- Keywords
- acute optic neuritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Neuro-Ophthalmologic Associates, PCUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Nov 2013 (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 goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Detailed description
Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| -ACHTHAR | Experimental | Drug: ACTHARSubcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- unilateral acute demyelinating optic neuritis
- Able to provide informed consent
- age 18 or older
- can perform the above listed electrophysiologic diagnostic testing
- can perform high and low contrast visual acuity and visual field perimetry
Key exclusion criteria (9 listed)
- prior diagnosis of remitting/relapsing multiple sclerosis(RRMS)
- secondary progressive MS(SPMS)
- primary progressive MS (PPMS)
- undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination)
- prior diagnosis of systemic lupus erythematosis
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 |
|---|---|---|
| ACTHARAlso: Repository CorticotropinInjectable Gel | Drug | -ACHTHAR |
Primary outcome
Neuro-protection
Time frame: 12 months
Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.
1 secondary outcome
Preservation of retinal nerve fiber layer.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Results publication: PubMed 28538037Moster ML, Sergott RC, Leiby BE. Dalfampridine Treatment in Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2017 Sep;37(3):348-349. doi: 10.1097/WNO.0000000000000523. No abstract available.
- Individual participant dataSharing planned: No
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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 C Sergott, M.D. principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ACTHAR in people with Optic Neuritis, run by Neuro-Ophthalmologic Associates, PC 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 22 Aug 2017. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neuro-protection (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01987167, which also lists 1 linked publication.
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 22 Aug 2017.