A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis

Phase 1

• Conditions: acute optic neuritis; MedDRA version: 20.0Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2018-001756-35-GB
• Lead Sponsor: niversity of California, San Francisco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Patients diagnosed or suspected to have an acute demyelinating optic neuritis within 2 weeks from the onset of any visual symptom other than pain.
2.Male and females patients aged 18-55 years (inclusive).
3.Use of disease modifying therapies is not a contraindication.
4.Use of appropriate contraception during period of trial (women). Before entry womenfemales of child-bearing potential as defined in Section 6.4.4 must be:
a.Post-menopausal for at least 1 year OR
b.Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise incapable of pregnancy) OR
c.Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study OR
d.Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) OR
e.Practicing true abstinence (when this is in line with the preferred and usal lifestyle of the subject) Period abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) is not an acceptable method.
5.Written informed consent must be obtained prior to any assessment being performed.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Major ophthalmologic disease /Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, glaucoma (narrow-angle glaucoma), severe myopia, peptic ulcer, pyloroduodenal obstruction, or prostatic hypertrophy with urinary retention and bladder neck obstruction, etc.), severe myopia, etc).
2.Hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients.
3.Treatment with corticosteroids within 30 days prior to screening.
4.Myopia > -7 Diopters (Severe myopia).
5.Disc hemorrhages in qualifying eye.
6.No light perception in qualifying eye.
7.Simultaneous bilateral optic neuritis.
8.Cotton wool spots in qualifying eye.
9.Macular star in qualifying eye.
10.History of significant cardiac conduction block.
11.History of cancer.
12.Suicidal ideation or behaviour in 6 months prior to baseline.
13.Pregnancy, breastfeeding, or planning to become pregnant.
14.Involved with other study protocol simultaneously without prior approval.
15.Concomitant use of any other putative remyelinating therapy as determined by investigator.
16.Concomitant use of Dalfamprdine or any other formulation of 4AP or diamino4ap.
17.Prior treatment with total lymphoid irradiation, T cell or T cell receptor vaccination.
18.Prior treatment with alemtuzamab, mitoxantrone, or cyclophosphamide.
19.Serum creatinine > 1.5 mg/dL; AST, ALT, or alkaline phosphatase > 2 times the upper limit of normal. (Reported within 72 hours)
20.History of drug or alcohol abuse within the past year.
21.Untreated B12 deficiency (as determined by B12 serological assessments and metabolites including methylmalonic acid [MMA] and homocysteine) or untreated hypothyroidism.
22.Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal or other major diseases that in the PI’s judgment may affect interpretation of study results or patient safety.
23.History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator would preclude participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified