CLINICAL TRIALS PROFILE FOR CLEMASTINE FUMARATE

All Clinical Trials for Clemastine Fumarate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01125761 ↗	Efficacy and Safety of the Association of Dexamethasone 0.5 mg + Clemastine Fumarate 1 mg When Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis	Withdrawn	Azidus Brasil	Phase 3	2010-11-01	Considering the pathogenesis of several allergic skin diseases to be investigated in this study as well as the pharmacodynamic mechanisms of the association of dexamethasone and clemastine fumarate, it is believed that the components of topical medication may act synergistically in the reduction of signs and symptoms of the diseases in question. Therefore it is expected that the association promotes results significantly superior to dexamethasone alone.
NCT01239719 ↗	Randomized Study for Effectiveness and Safety Evaluation of Dexamethasone 0.5 mg + Fumarate Clemastine 1 mg Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis	Unknown status	Azidus Brasil	Phase 3	2011-03-01	The aim of this study is to prove the efficacy of the dexamethasone 0.5 mg + 1 mg clemastine fumarate tablet compared to 0.5 mg of dexamethasone in reducing the signs and symptoms of allergic dermatitis.
NCT01257061 ↗	Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment	Completed	EMS	Phase 3	2012-09-06	Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.
NCT02040298 ↗	Assessment of Clemastine Fumarate as a Remyelinating Agent in Multiple Sclerosis	Completed	University of California, San Francisco	Phase 2	2014-01-01	The main purpose of this study is to assess clemastine as a remyelinating agent in patients with relapsing forms of multiple sclerosis. The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with multiple sclerosis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. The study will also assess the robustness and stability of this clinical effect in patients taking clemastine for up to 3 months. Patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.
NCT02521311 ↗	Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)	Recruiting	Moorfields Eye Hospital NHS Foundation Trust	Phase 2	2017-02-28	The main purpose of this study is to assess clemastine as a remyelinating agent in patients with acute optic neuritis.The study will also evaluate the tolerability of clemastine, originally approved as first-generation antihistamine, in patients with optic neuritis. Study procedures will include assessments for evidence of remyelination in the anterior visual pathway and in the brain using electrophysiologic techniques and magnetic resonance imaging. If they are on one, patients in this study can remain on their standard disease modifying treatment during the course of the study. However, patients cannot participate in any other investigational new drug research study concurrently.

Clinical Trial Conditions for Clemastine Fumarate

Condition Name

Condition Name for Clemastine Fumarate
Intervention	Trials
Multiple Sclerosis, Relapsing-Remitting	2
Multiple Sclerosis	2
Multiple Sclerosis Brain Lesion	2
Dermatitis	2

Condition MeSH

Condition MeSH for Clemastine Fumarate
Intervention	Trials
Multiple Sclerosis	5
Sclerosis	5
Dermatitis, Atopic	2
Dermatitis	2

Clinical Trial Locations for Clemastine Fumarate

Trials by Country

Trials by Country for Clemastine Fumarate
Location	Trials
United States	6
Brazil	2
Netherlands	1

Trials by US State

Trials by US State for Clemastine Fumarate
Location	Trials
California	5
Maryland	1

Clinical Trial Progress for Clemastine Fumarate

Clinical Trial Phase

Clinical Trial Phase for Clemastine Fumarate
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	2
Phase 1/Phase 2	3

Clinical Trial Status

Clinical Trial Status for Clemastine Fumarate
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for Clemastine Fumarate

Sponsor Name

Sponsor Name for Clemastine Fumarate
Sponsor	Trials
University of California, San Francisco	5
Azidus Brasil	2
National Institute of Neurological Disorders and Stroke (NINDS)	1

Sponsor Type

Sponsor Type for Clemastine Fumarate
Sponsor	Trials
Other	7
Industry	3
NIH	2

Clemastine Fumarate: Clinical Trials, Market Analysis, and Projections

Introduction to Clemastine Fumarate

Clemastine fumarate, traditionally known as an antihistamine, has been garnering significant attention in recent years for its potential in treating multiple sclerosis (MS), particularly in the context of myelin repair and remyelination.

Clinical Trials Update

Remyelination Therapy in Multiple Sclerosis

Several clinical trials are underway to assess the efficacy of clemastine fumarate as a remyelinating agent in patients with multiple sclerosis. Here are some key updates:

• UCSF Clinical Trials: A clinical trial at the University of California, San Francisco (UCSF), aims to evaluate clemastine fumarate as a myelin repair therapy in patients with chronic inflammatory injury-causing demyelination. This trial uses multi-parametric MRI assessments to measure the efficacy of clemastine fumarate. The pilot study, which was the first randomized control trial to document efficacy for a putative remyelinating agent in MS, showed promising results, meeting the primary efficacy endpoint (visual evoked potential) and showing a strong trend to benefit in the principal secondary endpoint (low contrast visual acuity)[1][4].

• RESTORE Trial: The RESTORE trial, conducted at the MS Centre Amsterdam, is a single-centre, double-blind, randomized placebo-controlled trial investigating the long-term remyelinating effects of clemastine fumarate in patients with MS and internuclear ophthalmoplegia (INO). This trial uses infrared oculography to measure remyelination and includes a test to predict treatment response using fampridine. Participants are randomized to receive either clemastine fumarate or a placebo for 6 months, with follow-up assessments at 6, 18, and 30 months after treatment cessation[3].

Key Findings and Outcomes

• Efficacy Endpoints: The trials have shown that clemastine fumarate meets primary efficacy endpoints, such as improvements in visual evoked potential and low contrast visual acuity. The RESTORE trial also focuses on the Versional Dysconjugacy Index-area under the curve, measured by infrared oculography, as a primary outcome[1][3].

• Long-term Effects: The long follow-up period in these trials allows for the study of sustained effects after treatment discontinuation, providing insights into the long-term neuroprotective effects of clemastine fumarate[3].

Market Analysis

Global Market Overview

The global clemastine fumarate market is experiencing significant growth, driven by its potential applications beyond traditional antihistaminic uses.

• Market Segmentation: The market is segmented based on type (Above 99.0% and Below 99.0%) and application (Antihistaminic and other applications). The Above 99.0% segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth in the near future[2][5].

• Regional Analysis: The market is analyzed across major regions including North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region provides detailed insights into market size, share, and growth trends[2].

Market Dynamics and Growth Drivers

• Growth Potential: The antihistaminic segment is expected to expand at a significant CAGR, retaining its position throughout the forecast period. The market is driven by increasing demand for remyelinating therapies in the treatment of multiple sclerosis[2].

• Competitive Landscape: Key players such as Sekisui Medical and Shandong Keyuan Pharmaceutical are focusing on strategy building to strengthen their product portfolios and expand their business in the global market. The competitive landscape includes detailed analyses of market share, revenue, and development plans of major players[2].

Market Trends and Opportunities

• Technological Trends: Advances in diagnostic techniques, such as multi-parametric MRI assessments and infrared oculography, are enhancing the ability to measure remyelination, thereby supporting the growth of the clemastine fumarate market[1][3].

• ESG and SWOT Analysis: The market report includes ESG (Environmental, Social, and Governance) analysis, SWOT analysis, and Porter's five forces analysis to provide a comprehensive understanding of the market's strengths, weaknesses, opportunities, and threats[2].

Market Projections

Forecast Period

The global clemastine fumarate market is forecasted to grow significantly from 2025 to 2031. Here are some key projections:

• Market Size and CAGR: The global clemastine fumarate market size in 2023 was substantial, and the compound annual growth rate (CAGR) is expected to be high from 2024 to 2031. The market is anticipated to expand driven by the increasing adoption of clemastine fumarate in MS treatment[2].

• Regional Growth: North America, Europe, and Asia-Pacific are expected to be key regions driving the market growth due to advanced healthcare infrastructure and high prevalence of multiple sclerosis[2].

Future Prospects

• Remyelination Therapies: The future prospects of clemastine fumarate are highly promising, given its potential as a remyelinating agent. As more clinical trials validate its efficacy, the market is likely to see significant expansion[1][3].

• Expanding Applications: Beyond MS, clemastine fumarate may find applications in other neurological conditions where myelin repair is crucial, further broadening its market potential[1].

Key Takeaways

• Clinical Efficacy: Clemastine fumarate has shown promising results in clinical trials as a remyelinating agent for multiple sclerosis.
• Market Growth: The global market is expected to grow significantly driven by the antihistaminic and potential remyelination segments.
• Regional Expansion: Key regions such as North America, Europe, and Asia-Pacific will drive market growth.
• Technological Advancements: Advances in diagnostic techniques are supporting the market growth.
• Future Prospects: The drug has high potential for use in various neurological conditions beyond MS.

FAQs

What is the primary use of clemastine fumarate in clinical trials?

Clemastine fumarate is being investigated primarily as a remyelinating agent in the treatment of multiple sclerosis.

Which regions are expected to drive the growth of the clemastine fumarate market?

North America, Europe, and Asia-Pacific are expected to be key regions driving the market growth.

What are the key endpoints measured in clinical trials of clemastine fumarate for MS?

Key endpoints include visual evoked potential, low contrast visual acuity, and the Versional Dysconjugacy Index-area under the curve measured by infrared oculography.

How long do the clinical trials follow up with patients after treatment cessation?

The RESTORE trial follows up with patients for 3 years after treatment cessation to study long-term effects.

What is the significance of fampridine in the RESTORE trial?

Fampridine is used in the RESTORE trial to predict the treatment response to clemastine fumarate by measuring improvement in oculographic features of internuclear ophthalmoplegia.

Sources

1. UCSF Relapsing-Remitting Multiple Sclerosis Clinical Trials for 2024 - UCSF Clinical Trials.
2. Global Clemastine Fumarate Market Report 2024 Edition - Cognitive Market Research.
3. Measuring and predicting the effect of remyelinating therapy in multiple sclerosis - BMJ Open.
4. Multiple Sclerosis clinical trials at University of California Health - University of California Health.
5. Global Clemastine Fumarate Professional Survey Report 2022, Forecast to 2027 - 360 Market Updates.