CLINICAL TRIALS PROFILE FOR CARNITOR

All Clinical Trials for CARNITOR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00481013 ↗	Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy	Completed	Abbott	Phase 2	2007-07-01	The primary objective of this proposal is to determine whether oral VPA is effective in treating SMA in adult patients.
NCT00481013 ↗	Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy	Completed	Families of Spinal Muscular Atrophy	Phase 2	2007-07-01	The primary objective of this proposal is to determine whether oral VPA is effective in treating SMA in adult patients.
NCT00227266 ↗	Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy	Completed	Abbott	Phase 2	2005-09-01	This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes. Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.
NCT00227266 ↗	Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy	Completed	Families of Spinal Muscular Atrophy	Phase 2	2005-09-01	This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes. Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.
NCT00227266 ↗	Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy	Completed	Leadiant Biosciences, Inc.	Phase 2	2005-09-01	This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes. Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.
NCT00227266 ↗	Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy	Completed	Sigma Tau Pharmaceuticals, Inc.	Phase 2	2005-09-01	This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes. Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.
NCT00227266 ↗	Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy	Completed	University of Utah	Phase 2	2005-09-01	This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes. Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.

Clinical Trial Conditions for CARNITOR

Condition Name

Condition Name for CARNITOR
Intervention	Trials
Spinal Muscular Atrophy	2
Carnitine Deficiency	2
Hyperbilirubinemia	1
Lymphoblastic Lymphoma	1

Condition MeSH

Condition MeSH for CARNITOR
Intervention	Trials
Leukemia, Lymphoid	2
Leukemia	2
Muscular Atrophy, Spinal	2
Muscular Atrophy	2

Clinical Trial Locations for CARNITOR

Trials by Country

+

−

Trials by Country for CARNITOR
Location	Trials
United States	8
Canada	2
Netherlands	1

Trials by US State

+

−

Trials by US State for CARNITOR
Location	Trials
Ohio	2
Texas	1
New York	1
Wisconsin	1
Utah	1

Clinical Trial Progress for CARNITOR

Clinical Trial Phase

Clinical Trial Phase for CARNITOR
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for CARNITOR
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for CARNITOR

Sponsor Name

Sponsor Name for CARNITOR
Sponsor	Trials
University of Utah	2
Abbott	2
Families of Spinal Muscular Atrophy	2

Sponsor Type

Sponsor Type for CARNITOR
Sponsor	Trials
Other	11
Industry	4
NIH	1

CARNITOR®: Clinical Trials, Market Analysis, and Projections

Introduction to CARNITOR®

CARNITOR® (levocarnitine) is a medication used to treat carnitine deficiency, a condition where the body does not have enough carnitine, a critical nutrient involved in energy production. Here, we will delve into the clinical trials, market analysis, and projections for CARNITOR®.

Clinical Trials and Efficacy

Increasing Carnitine Levels

Clinical data indicate that CARNITOR® is effective in increasing carnitine levels in patients experiencing deficiency. This is crucial as carnitine plays a vital role in the transport of fatty acids into the mitochondria, where they are oxidized to produce energy[1].

Specific Clinical Trials

While specific trials on CARNITOR® itself are detailed in terms of its efficacy in increasing carnitine levels, related studies on carnitine derivatives provide additional insights. For example, a Phase 3 clinical trial on Acetyl-L-Carnitine (ALC) for treating diabetic peripheral neuropathy (DPN) showed significant improvements in clinical neuropathy scores compared to the placebo group. This study highlights the broader therapeutic potential of carnitine and its derivatives[4].

Market Analysis

Global L-Carnitine Market

The global L-carnitine market, which includes CARNITOR®, is projected to grow significantly over the coming years. Here are some key points:

• Market Size and Growth: The global L-carnitine market was valued at USD 203.4 million in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 4.9% from 2023 to 2030, reaching USD 298.7 million by 2030[5].
• Application Segments: The market is driven by various application segments, including healthcare products, animal feed, functional drinks, and medicines. Healthcare products dominated the market with a revenue share of 34.7% in 2022[5].

Regional Outlook

• North America: This region dominated the L-carnitine market with a revenue share of 37.9% in 2022, driven by the expanding health-conscious consumer base and high demand for dietary supplements[5].
• Other Regions: Europe, Asia Pacific, Central and South America, and the Middle East & Africa also contribute significantly to the market, with each region showing growth potential due to increasing awareness and demand for L-carnitine products[5].

Market Drivers

Growing Consumer Awareness

The market is driven by growing consumer awareness regarding the benefits of L-carnitine, such as improvement in muscle repair, reduction in muscle soreness, and muscle gain. This awareness is leading to increased demand from end-use industries like pharmaceuticals, nutraceuticals, and animal feed[2][5].

Increasing Demand from End-Use Industries

• Pharmaceuticals: L-carnitine is used in treating various conditions, including male infertility, kidney treatment, cardiovascular diseases, and weight reduction.
• Nutraceuticals: It is a key ingredient in health supplements, functional drinks, and other nutraceutical products.
• Animal Feed: L-carnitine is essential for the growth performance of various animal species, providing dietary energy and protein[2][5].

Market Challenges and Opportunities

Challenges

• Competition: The L-carnitine market faces competition from other nutritional supplements and energy boosters.
• Regulatory Frameworks: Strict regulatory requirements can pose challenges for new product launches and market expansion.

Opportunities

• Expanding Health-Conscious Consumer Base: The growing health-conscious consumer base, especially in regions like North America, presents significant opportunities for market growth.
• Increasing Use in Animal Feed: The demand for L-carnitine in animal feed is rising, driven by the need for improved animal nutrition and performance[5].

Key Takeaways

• Clinical Efficacy: CARNITOR® is clinically proven to increase carnitine levels in deficient patients.
• Market Growth: The global L-carnitine market is expected to grow at a CAGR of 4.9% from 2023 to 2030.
• Regional Dominance: North America leads the market, driven by a health-conscious consumer base.
• Diverse Applications: L-carnitine is used in various industries, including pharmaceuticals, nutraceuticals, and animal feed.
• Growing Consumer Awareness: Increasing awareness of L-carnitine benefits drives market demand.

FAQs

What is CARNITOR® used for?

CARNITOR® (levocarnitine) is used to treat carnitine deficiency, a condition where the body does not have enough carnitine.

What is the projected growth rate of the global L-carnitine market?

The global L-carnitine market is expected to grow at a CAGR of 4.9% from 2023 to 2030.

Which region dominates the L-carnitine market?

North America dominates the L-carnitine market, driven by the expanding health-conscious consumer base.

What are the main application segments of the L-carnitine market?

The main application segments include healthcare products, animal feed, functional drinks, and medicines.

What drives the demand for L-carnitine in the market?

Growing consumer awareness regarding the benefits of L-carnitine and increasing demand from end-use industries such as pharmaceuticals, nutraceuticals, and animal feed drive the market demand.

Sources

1. CARNITOR® - Clinical Outcomes. Carnitor.com.
2. L-Carnitine Market Size Worth $233.8 Million by 2025 | CAGR: 4.8%. PR Newswire.
3. Clinical Trials Market Size, Share & Analysis Report, 2024-2033. Novaoneadvisor.com.
4. A Phase 3 Randomized Clinical Trial in China | Diabetes. Diabetesjournals.org.
5. L-carnitine Market Size, Share & Trends Analysis Report, 2030. Grandviewresearch.com.