Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT01524250
Eligibility Criteria:
Inclusion Criteria:
1. Males/Females who are ≥ 18 years old and \< 65 years old and are capable of understanding and complying with the protocol
2. Have a diagnosis of unilateral acute demyelinating optic neuritis and will be treated with high dose corticosteroids
3. Are within 14 days of symptom onset
4. Have a visual acuity in the affected of eye of ≥ 20/40
5. Have not received corticosteroids in the last thirty (30) days
6. Medications that could potentially affect the VEP P100 amplitude or may cause drowsiness/difficulty with visual fixation are allowed if there has been no change in dose within 30 days of study enrollment or anytime during the study. These medications include:
1. Carbamazepine or other anticonvulsants (45)
2. Benzodiazepines
3. Opioid and opiates
4. Barbiturates
5. Sleep aids such as zopiclone or trazadone
6. Tricyclic antidepressants
7. Have given written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care
Exclusion Criteria:
1. Have another medical condition that could affect the visual outcomes, such as, but not limited to, diabetes retinopathy, glaucoma, cataracts and optic neuropathy not due to a demyelinating lesion
2. Have had optic neuritis in the same eye previously
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01524250
Study Brief:
Protocol Section:
NCT01524250