CLINICAL TRIALS PROFILE FOR MYSOLINE

All Clinical Trials for MYSOLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00016679 ↗	1-Octanol to Treat Essential Tremor	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1	2001-05-01	This study will determine the optimal dose of 1-octanol that will safely reduce tremors in patients with essential tremor-a disorder in which the hands, and sometimes the head, shake involuntarily. Current treatments may be ineffective or produce unwanted side effects. Ethanol (the chemical in beer and wine that causes intoxication) reduces tremor in many patients, but patients generally don't use it regularly because it interferes with daily activities. Laboratory studies show that 1-octanol, a drug that is similar to ethanol, may have the same beneficial effect on tremors with less likelihood of intoxication. Patients 21 years of age and older with essential tremor may be eligible for this 10-day study. Candidates will be evaluated with a neurological examination, blood tests, urinalysis and electrocardiogram (EKG). Those enrolled will be admitted to the hospital for 4 days for 1-octanol administration and monitoring. On day 1, patients will have a medical history and physical examination. A catheter (a thin plastic tube) will be placed in a vein of the forearm for sampling blood. Patients will take one 1-octanol capsule (at one of seven doses) by mouth and will be monitored for tremors and drug side effects. Blood will be sampled periodically in the first 3 hours to determine 1-octanol blood levels. On days 2 and 3, patients will be monitored for additional side effects. On days 3 and 4, laboratory tests (blood and urine) will be done to evaluate liver and kidney function. On day 4, the catheter will be removed and the patient will be discharged from the hospital. A follow-up visit will be scheduled 1 week after discharge for a physical examination and blood, urine and EKG tests.
NCT00080366 ↗	Octanol to Treat Essential Tremor	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-03-01	This study will evaluate the effectiveness of 1-octanol, a substance similar to alcohol but less intoxicating, for treating essential tremor. Essential tremor is an involuntary shaking, usually of the hands, for which there is no satisfactory treatment. It affects about 1.4 percent of the general U.S. population, with the figure climbing to nearly 4 percent among people over 40. Results of two previous NIH studies have shown 1-octanol to be promising as a potential new treatment. This study will test the effectiveness of 1-octanol on essential tremor at doses lower than those given previously. Patients 21 years old and older with essential tremor may be eligible for this study. Participants are admitted to the NIH Clinical Center for two treatment periods of 1 week each, with a 1-week break at home between treatments. Before beginning treatment, participants undergo a medical history, physical examination, blood and urine tests, and an electrocardiogram (EKG). In addition, tremors are measured using accelerometry, a procedure in which a small device, mounted on a piece of cardboard, is taped to the patient's hand for about 30 minutes. Patients are randomly assigned to one of two groups. One group takes 2 to 4 capsules of 1-octanol 3 times a day for 1 week, followed by a 1-week "washout" period (no treatment), and then 2 to 4 capsules of placebo 3 times a day for 1 week. Following the same dosage schedule, the second group takes placebo the first week, followed by the washout period and then 1-octanol treatment. Blood pressure and pulse are measured at 15, 30, and 60 minutes after the first dose of the day and then 3 times a day each day of hospitalization, EKG and blood draws are done every other day during hospitalization, and blood is drawn again 1 week after the end of the study. Patients evaluate their tremor daily according to a tremor scale and are also rated according to an alcohol intoxication scale.
NCT00685165 ↗	Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets	Completed	Mutual Pharmaceutical Company, Inc.	Phase 1	2004-05-01	The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions.

Clinical Trial Conditions for MYSOLINE

Condition Name

Condition Name for MYSOLINE
Intervention	Trials
Essential Tremor	2
Gastrointestinal Hemorrhage	1
Healthy	1

Condition MeSH

Condition MeSH for MYSOLINE
Intervention	Trials
Tremor	2
Essential Tremor	2
Hemorrhage	1

Clinical Trial Locations for MYSOLINE

Trials by Country

Trials by Country for MYSOLINE
Location	Trials
United States	2
China	1
India	1

Trials by US State

Trials by US State for MYSOLINE
Location	Trials
Maryland	2

Clinical Trial Progress for MYSOLINE

Clinical Trial Phase

Clinical Trial Phase for MYSOLINE
Clinical Trial Phase	Trials
Phase 2	2
Phase 1	3

Clinical Trial Status

Clinical Trial Status for MYSOLINE
Clinical Trial Phase	Trials
Completed	4
Withdrawn	1

Clinical Trial Sponsors for MYSOLINE

Sponsor Name

Sponsor Name for MYSOLINE
Sponsor	Trials
National Institute of Neurological Disorders and Stroke (NINDS)	2
Shanghai Jiao Tong University School of Medicine	1
Mutual Pharmaceutical Company, Inc.	1

Sponsor Type

Sponsor Type for MYSOLINE
Sponsor	Trials
NIH	2
Industry	2
Other	1

Last updated: May 5, 2026

MYSOLINE: Clinical-Trial Update, Market Analysis, and Projection

What is MYSOLINE and how is it positioned clinically?

Mysoline is the brand name for primidone (an older antiseizure medicine). Its clinical role is established: treatment of epilepsy (historically including generalized tonic-clonic seizures) and use patterns that vary by guideline and geography. Primidone is also used in essential tremor in some markets, but global uptake for tremor depends on reimbursement and competing therapy access.

No specific sponsor, formulation, or current Phase pipeline identifiers tied to the exact brand “MYSOLINE” are provided in the input. As a result, a complete “clinical trials update” for the brand name itself cannot be produced without risking mixing non-identical products, salts, or geographies.

What clinical-trials signals exist that can be summarized for primidone?

A brand-level clinical-trials update for “MYSOLINE” cannot be generated from the provided information because MYSOLINE may map to multiple national registrations, and primidone clinical activity is not reliably traceable to that exact label without an explicit country and marketing authorization holder.

The only defensible clinical-trial summary that can be produced from the input is the drug class and expected trial profile of an older antiseizure agent: routine investigations typically center on formulation, bioequivalence, safety/observational studies, and older-label regimen optimization, rather than novel mechanism registrational programs. However, no trial IDs, dates, endpoints, or sponsor updates were included, so a data-backed update is not possible.

What does the antiseizure market look like for primidone-based therapy?

Primidone is a legacy oral antiseizure therapy. Market sizing for legacy antiseizure drugs is typically constrained by:

• Patent and exclusivity status: primidone is off-patent in most jurisdictions.
• Generic competition: price is pressured by multiple generics and tender dynamics.
• Formulary substitution: prescribers often default to more modern antiseizure options when reimbursement permits.
• Segment variability: demand differs between epilepsy subtypes and essential tremor use.

Market drivers that matter for an off-patent antiseizure product

• Local tender and reimbursement: drives volume more than clinical differentiation.
• Switching behavior: antiseizure regimens are “sticky,” but generic substitution is common once stable dosing is established.
• Adherence and tolerability: primidone has known tolerability constraints (sedation, dizziness, dose titration needs), which can reduce uptake versus better-tolerated alternatives.

Key constraints for pricing and growth

• Low margin headroom due to generic price competition.
• Limited willingness to pay among public payers for older therapies unless they are the lowest-cost option.
• Higher utilization risk when new-line antiseizure medicines displace older standards of care.

How should projections be framed for MYSOLINE?

A robust market projection requires at least one of the following: country scope, formulation strength, treatment segment (epilepsy vs tremor), pricing assumptions, or historical sales. None are provided. Without that, any numeric projection would be speculative.

A non-speculative projection for an off-patent legacy product must be expressed as directionality rather than a quantified forecast. For MYSOLINE (primidone), the directionality is typically:

• Stable to declining share in formularies that increasingly prefer newer antiseizure therapies.
• Stable volume in cost-sensitive segments where the lowest-cost generic antiseizure medicine is preferred.
• Value erosion from continuous generic price compression.

What is the likely competitive landscape for MYSOLINE?

For primidone, competition is primarily generic primidone and second-line use influenced by:

• Higher tolerability profiles of newer antiseizure medicines
• Brand-to-generic substitution policies
• Prescriber comfort with titration and adverse-event management

In most markets, MYSOLINE competes on:

• Net price after tenders
• Supply continuity
• Formulary positioning (preferred list vs restricted list)

What patent and exclusivity posture should be assumed for MYSOLINE?

Primidone is a mature compound with long-standing availability. In practical business terms, an older oral antiseizure medicine like primidone generally has:

• No enforceable composition-of-matter patent remaining
• Possible remnants only at the level of specific formulations or manufacturing processes, if any exist in a given country
• Market protection driven mainly by regulatory listing strategies and formulary status, not patent exclusivity

Because the input includes no jurisdiction and no patent numbers, no itemized exclusivity map can be produced.

Clinical-trial update, market analysis, and projection: what can be concluded from the provided data?

• A brand-level clinical trial update for “MYSOLINE” cannot be completed without identifiers tying trials to the exact brand registration.
• A numerical market size and forecast cannot be completed without country scope and baseline commercial figures.
• A directional projection is still possible: primidone brand performance is constrained by generic competition and formulary preference for newer antiseizure options.

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Key Takeaways

• MYSOLINE is primidone, a legacy oral antiseizure medicine; growth is structurally limited by generic competition and formulary substitution dynamics.
• A data-backed clinical-trials update for the brand cannot be produced from the provided input because no trial IDs, jurisdictions, or sponsor/registration links were supplied.
• A numerical market forecast is not supportable from the provided input; only directional expectations fit the constraints (stable volume in cost-sensitive niches, ongoing price erosion, and potential share erosion versus newer therapies).

FAQs

1. Is MYSOLINE a patented product?
   Primidone is generally treated as off-patent; any remaining protection is usually limited to specific local formulation/process matters rather than the active ingredient.

2. What disease areas drive primidone demand?
   Primidone is used for epilepsy and sometimes essential tremor depending on local guideline and reimbursement patterns.

3. Why does the market for older antiseizure drugs face pricing pressure?
   Generic penetration and tender-driven procurement compress net prices, limiting value growth even if patient volumes remain stable.

4. What kind of studies typically show up for older antiseizure medicines?
   Common patterns include observational studies, safety and tolerability follow-ups, and regulatory bioequivalence or formulation work rather than first-in-class trials.

5. How should an investor or R&D planner approach projections for MYSOLINE?
   Use scenario models based on local formulary status and net pricing rather than expecting patent-style growth; attach forecast ranges to procurement and reimbursement volatility.

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References

[1] FDA. Drugs@FDA: Drug Approval Reports and Labels (Primidone information in the Drugs@FDA database). U.S. Food and Drug Administration.
[2] EMA. European public assessment reports and product information for primidone-related medicinal products (EMA database). European Medicines Agency.
[3] NICE. Epilepsies in children, young people and adults (guideline documents relevant to antiseizure prescribing patterns). National Institute for Health and Care Excellence.
[4] WHO. ATC classification for primidone and antiseizure medicine mapping (WHO ATC/DDD). World Health Organization.