CLINICAL TRIALS PROFILE FOR TIAGABINE HYDROCHLORIDE

All Clinical Trials for TIAGABINE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	National Cancer Institute (NCI)	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00086255 ↗	Tiagabine for the Treatment of Cocaine Dependence - 1	Completed	University of Cincinnati	Phase 2	2002-10-01	The purpose of this study is to assess tiagabine for the treatment of cocaine dependence.
NCT00015769 ↗	Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-04-01	This study will explore the possible effectiveness of levetiracetam in patients with bipolar illness who have not responded adequately to standard treatments. Levetiracetam was recently approved to treat seizures. Other drugs in the same class as levetiracetam, including carbamazepine and valproate, are widely recognized as substitute medications for lithium or are used as an adjunct to it, and other anticonvulsants have also shown promise in improving bipolar symptoms. Patients with bipolar illness whose manic, depressed or unstable moods are not adequately controlled by their current treatment and who have not responded previously to two standard treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this study. Participants will take levetiracetam starting at 500 mg daily. If this dose is well tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may be tried in patients who do not respond fully to the lower doses. Patients and observers will use standard ratings to evaluate the patients' response to therapy during the 8-week study. If, after 8 weeks, the results appear promising, patients may continue treatment for an additional 6 months to evaluate longer-term effects.
NCT00015132 ↗	Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1999-03-01	The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified placebo-controlled experimental design.

Clinical Trial Conditions for TIAGABINE HYDROCHLORIDE

Condition Name

Condition Name for TIAGABINE HYDROCHLORIDE
Intervention	Trials
Cocaine-Related Disorders	5
Epilepsy	2
Alcoholism	2
Focal Epilepsy	1

Condition MeSH

Condition MeSH for TIAGABINE HYDROCHLORIDE
Intervention	Trials
Cocaine-Related Disorders	5
Epilepsy	4
Anxiety Disorders	3
Epilepsies, Partial	3

Clinical Trial Locations for TIAGABINE HYDROCHLORIDE

Trials by Country

+

−

Trials by Country for TIAGABINE HYDROCHLORIDE
Location	Trials
United States	43

Trials by US State

+

−

Trials by US State for TIAGABINE HYDROCHLORIDE
Location	Trials
Massachusetts	6
Pennsylvania	3
Georgia	3
Maryland	3
Ohio	3

Clinical Trial Progress for TIAGABINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for TIAGABINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	2
Phase 2	8

Clinical Trial Status

Clinical Trial Status for TIAGABINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	15
Terminated	3
Active, not recruiting	1

Clinical Trial Sponsors for TIAGABINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for TIAGABINE HYDROCHLORIDE
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	5
Cephalon	2
Vanderbilt University	1

Sponsor Type

Sponsor Type for TIAGABINE HYDROCHLORIDE
Sponsor	Trials
Other	16
Industry	8
NIH	7

Tiagabine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Tiagabine hydrochloride, marketed under the brand name Gabitril, is a selective GABA reuptake inhibitor (SGRI) used primarily as an adjunctive therapy for the treatment of partial seizures. This article delves into the clinical trials, market analysis, and future projections for tiagabine hydrochloride.

Clinical Trials and Efficacy

Dosing and Titration Schedules

A significant clinical trial evaluated the safety and compliance of tiagabine using two different tablet strengths with different titration schedules. The study involved a multicenter, randomized, parallel-group, open-label trial where patients received either a standard regimen (4 mg once daily, increased by 4 mg weekly) or a contrast regimen (2 mg every 3-4 days)[1].

• The results showed that both dosing schedules were well tolerated, with high patient compliance (85% in both groups).
• The study indicated that the more flexible titration schedule of 2 mg every 3-4 days allowed patients to achieve the desired clinical response earlier in the treatment course.

Efficacy in Refractory Partial Seizures

A double-blind, placebo-controlled trial assessed the efficacy of tiagabine as add-on therapy in patients with refractory partial seizures. The trial found that tiagabine, at doses of 10 mg administered three times daily, significantly reduced the median 4-weekly seizure rate for all partial seizures and simple partial seizures. The drug was generally well tolerated, with common adverse events including dizziness, asthenia, headache, and somnolence[4].

Market Analysis

Global Market Trends

The global tiagabine hydrochloride market is experiencing solid growth driven by increasing demand worldwide. Recent advancements and the expansion strategies of key players are contributing to this growth. Here are some key market trends:

• Regional Growth: The market is segmented across six key regions, with North America, Europe, China, and Japan being significant contributors. The COVID-19 pandemic has impacted the market, but it is expected to grow steadily over the forecast period (2021-2028)[2].
• Market Size and Forecast: The global tiagabine hydrochloride market is projected to grow based on historical data and current trends. The market report provides detailed information on market size, revenue share, and forecasted growth up to 2028[5].

Market Drivers and Challenges

Several factors are driving the growth of the tiagabine hydrochloride market:

• Increasing Demand: The rising prevalence of epilepsy and the need for effective adjunctive therapies are key drivers.
• Advancements in Drug Formulations: Continuous innovation in drug delivery and formulation technologies is enhancing the therapeutic efficacy of tiagabine hydrochloride.
• Competition and Expansion: Key players are expanding their capacities and forming strategic alliances to cater to the increasing demand, which is a significant market driver[2].

However, the market also faces challenges such as regulatory hurdles and the availability of generic and biosimilar versions, which can impact market dynamics.

Market Projections

Forecasted Growth

The global tiagabine hydrochloride market is expected to grow steadily over the next few years. Here are some key projections:

• Market Size: The market is forecasted to grow based on historical data and current trends, with detailed forecasts provided up to 2028[5].
• Regional Expansion: The market is expected to expand in regions such as North America, Europe, China, and Japan, driven by increasing healthcare expenditure and the growing incidence of epilepsy[2].

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on various industries, including the pharmaceutical sector. However, the tiagabine hydrochloride market is expected to recover and grow steadily as healthcare systems adapt to the new landscape.

"The COVID-19 pandemic has impacted numerous industries around the globe. This report covers the impact of COVID-19 on the Tiagabine HCl Market and predicts the market to grow steadily over 2021-2028."[2]

Competitive Landscape

Key Players

The tiagabine hydrochloride market is competitive, with several key players involved in its production and distribution. These players are adopting strategies such as expanding their capacities, forming strategic alliances, and investing in local production facilities to cater to the growing demand.

• Business Strategies: Key players are focusing on core expansion, geographical expansion, and innovation in drug delivery and formulation technologies to maintain their market position[2].

Regulatory and Safety Considerations

Safety Profile

Clinical trials have shown that tiagabine hydrochloride is generally well tolerated, with most drug-related adverse events being mild or moderate in severity. The most common adverse events include dizziness, asthenia, headache, and somnolence[4].

Compliance and Patient Adherence

High patient compliance rates have been observed in clinical trials, with both dosing schedules showing compliance rates of 85%[1].

Conclusion

Tiagabine hydrochloride remains a significant adjunctive therapy for the treatment of partial seizures. The drug's efficacy, safety profile, and flexible dosing schedules make it a preferred choice for many patients.

Key Takeaways

• Clinical Efficacy: Tiagabine hydrochloride has been shown to be effective in reducing seizure rates in patients with refractory partial seizures.
• Market Growth: The global market for tiagabine hydrochloride is expected to grow steadily driven by increasing demand and advancements in drug formulations.
• Compliance: High patient compliance rates have been observed with both standard and flexible dosing schedules.
• Regulatory and Safety: The drug is generally well tolerated, with a favorable safety profile.

FAQs

What is tiagabine hydrochloride used for?

Tiagabine hydrochloride is used as an adjunctive therapy for the treatment of partial seizures, with or without secondary generalization.

What are the common dosing schedules for tiagabine hydrochloride?

The common dosing schedules include a standard regimen of 4 mg once daily increased by 4 mg weekly and a flexible regimen of 2 mg every 3-4 days.

What are the most common adverse events associated with tiagabine hydrochloride?

The most common adverse events include dizziness, asthenia, headache, and somnolence.

How is the global tiagabine hydrochloride market expected to grow?

The global market is expected to grow steadily over the next few years, driven by increasing demand and advancements in drug formulations.

What impact did the COVID-19 pandemic have on the tiagabine hydrochloride market?

The COVID-19 pandemic had a significant impact, but the market is expected to recover and grow steadily as healthcare systems adapt to the new landscape.

Sources

1. Fakhoury, T. A., et al. "Evaluating the Safety and Compliance of Tiagabine Using 2 Different Tablet Strengths with Different Titration Schedules." American Epilepsy Society, 2002.
2. Stratagem Market Insights. "Tiagabine HCl Market Analysis 2021: Industry Size, Share, Growth, Trends and Forecast to 2028."
3. GlobeNewswire. "Gemcitabine Hydrochloride Strategic Industry Research Report 2023-2030: Global Market to Reach $1.1 Billion, Growth in Home Chemotherapy and Outpatient Cancer Care Expand Opportunities."
4. Kalviainen, R., et al. "A double-blind, placebo-controlled trial of tiagabine given three times daily as add-on therapy for refractory partial seizures." Neurology, vol. 51, no. 1, 1998, pp. 212-218.
5. Cognitive Market Research. "Global Tiagabine HCl Market Report 2024 Edition."