CLINICAL TRIALS PROFILE FOR NARATRIPTAN HYDROCHLORIDE

All Clinical Trials for Naratriptan Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00282165 ↗	Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order	Terminated	FPC De Kijvelanden, Poortugaal	Phase 4	2006-11-01	In a double blind randomized clinical trial with cross-over design, treatment using naratriptan will be compared to placebo within a group of 30 convicts with psychiatric disorders such as psychosis or psychopathy with repeated aggressive outbursts resistant to conventional psychopharmacologic and other psychotherapeutic treatment. Hypothesis is that addition of naratriptan to the individual treatment regime reduces aggression -and improves general outcome- as compared to addition of placebo and is well tolerated in this group and under these conditions.
NCT00282165 ↗	Efficacy of a Triptan in the Treatment of Hostility and Aggression Among Convicts With a Psychiatric Treatment Order	Terminated	UMC Utrecht	Phase 4	2006-11-01	In a double blind randomized clinical trial with cross-over design, treatment using naratriptan will be compared to placebo within a group of 30 convicts with psychiatric disorders such as psychosis or psychopathy with repeated aggressive outbursts resistant to conventional psychopharmacologic and other psychotherapeutic treatment. Hypothesis is that addition of naratriptan to the individual treatment regime reduces aggression -and improves general outcome- as compared to addition of placebo and is well tolerated in this group and under these conditions.
NCT00487578 ↗	Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction	Terminated	Clinvest	Phase 4	2006-10-01	The purpose of this study is to determine whether naratriptan, a medication approved for treatment of migraine, is effective in the treatment of post traumatic headache associated with cognitive dysfunction.
NCT00487578 ↗	Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction	Terminated	GlaxoSmithKline	Phase 4	2006-10-01	The purpose of this study is to determine whether naratriptan, a medication approved for treatment of migraine, is effective in the treatment of post traumatic headache associated with cognitive dysfunction.
NCT00487578 ↗	Naratriptan for the Treatment of Post Traumatic Headache Associated With Cognitive Dysfunction	Terminated	Cady, Roger, M.D.	Phase 4	2006-10-01	The purpose of this study is to determine whether naratriptan, a medication approved for treatment of migraine, is effective in the treatment of post traumatic headache associated with cognitive dysfunction.
NCT01059604 ↗	Sumatriptan and Naratriptan Pregnancy Registry	Completed	GlaxoSmithKline		2001-12-01	Anti-migraine drugs, including triptans, are not indicated for use in pregnancy. However, the peak prevalence of migraine is in women of childbearing age. This, coupled with the sporadic nature of migraine attacks and high rates of unplanned pregnancies, makes unintentional exposure to anti-migraine medications during pregnancy likely. Prior to an anti-migraine medication being marketed there are few data available on drug safety in pregnancy: data from animal models may not translate directly to humans and pregnant women are routinely excluded from clinical trials. The Sumatriptan Pregnancy Registry was established by GlaxoSmithKline (GSK) in 1996 to monitor the safety of sumatriptan during pregnancy. It was combined with the Naratriptan Pregnancy Registry in 2001 and data collection on the sumatriptan-naproxen combination (Treximet) began in 2008.

Clinical Trial Conditions for Naratriptan Hydrochloride

Condition Name

Condition Name for Naratriptan Hydrochloride
Intervention	Trials
Migraine	4
Migraine Disorders	3
Headache	2
Impulse Regulation Disorder	1

Condition MeSH

Condition MeSH for Naratriptan Hydrochloride
Intervention	Trials
Migraine Disorders	6
Headache	3
Aggression	1
Psychotic Disorders	1

Clinical Trial Locations for Naratriptan Hydrochloride

Trials by Country

Trials by Country for Naratriptan Hydrochloride
Location	Trials
United States	5
Netherlands	1

Trials by US State

Trials by US State for Naratriptan Hydrochloride
Location	Trials
Washington	2
North Carolina	1
Missouri	1
Texas	1

Clinical Trial Progress for Naratriptan Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Naratriptan Hydrochloride
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Naratriptan Hydrochloride
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Withdrawn	2

Clinical Trial Sponsors for Naratriptan Hydrochloride

Sponsor Name

Sponsor Name for Naratriptan Hydrochloride
Sponsor	Trials
GlaxoSmithKline	4
Roxane Laboratories	2
Ache Laboratorios Farmaceuticos S.A.	2

Sponsor Type

Sponsor Type for Naratriptan Hydrochloride
Sponsor	Trials
Industry	10
Other	4

Naratriptan Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Naratriptan hydrochloride, formerly known under the brand name Amerge, is a medication primarily used for the acute treatment of migraine headaches. This article delves into the clinical trials that have evaluated its efficacy, the current market analysis, and projections for its future growth.

Clinical Trials Overview

Efficacy in Migraine Treatment

The efficacy of naratriptan in treating migraine headaches has been extensively evaluated in three randomized, double-blind, placebo-controlled trials involving adult patients[1].

• Headache Response: Patients were instructed to treat at least one moderate to severe headache. The primary outcome measure was the headache response, defined as a reduction in headache severity from moderate or severe to mild or no pain, assessed up to 4 hours after dosing.
• Associated Symptoms: Symptoms such as nausea, vomiting, photophobia, and phonophobia were also assessed.
• Maintenance of Response: The maintenance of response was evaluated for up to 24 hours post-dose.
• Dosing and Response Rates: The trials showed that the percentage of patients achieving headache response 4 hours after treatment was significantly greater among those receiving naratriptan compared to those receiving a placebo. Specifically, the response rates were:
  • Trial 1: 50% for 1 mg and 60% for 2.5 mg of naratriptan, compared to 34% for placebo.
  • Trial 2: 52% for 1 mg and 66% for 2.5 mg of naratriptan, compared to 27% for placebo.
  • Trial 3: 54% for 1 mg and 65% for 2.5 mg of naratriptan, compared to 32% for placebo.

Dosage and Efficacy

The trials indicated that the 2.5 mg dose of naratriptan was more effective than the 1 mg dose, with no additional benefit observed at doses of 5 mg[1].

Safety and Tolerability

Naratriptan was generally well-tolerated, with no evidence suggesting an increase in the severity or frequency of migraine attacks. The drug's efficacy was not affected by factors such as the presence of aura, gender, age, weight, oral contraceptive use, or concomitant use of common migraine prophylactic drugs[1].

Pharmacokinetics and Special Populations

Pharmacokinetic Profile

Naratriptan has a mean elimination half-life of 6 hours and a systemic clearance of 6.6 mL/min/kg. The renal clearance exceeds the glomerular filtration rate, indicating active tubular secretion. Repeat administration does not result in drug accumulation[4].

Special Populations

• Age: A small decrease in clearance was observed in healthy elderly subjects, resulting in slightly higher exposure.
• Renal Impairment: Clearance of naratriptan was reduced by 50% in patients with moderate renal impairment, leading to an increased mean half-life and higher Cmax[4].

Market Analysis and Projections

Current Market Size and Growth

The naratriptan hydrochloride market has experienced significant growth in recent years. As of 2023, the market size is substantial, and it is anticipated to continue expanding through 2031. The market is segmented by type (less than 98%, 98% to 99%, more than 99%), application (biopharmaceutical, laboratory, others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Market Dynamics

The market is driven by several factors, including increasing demand for effective migraine treatments and advancements in pharmaceutical technology. However, it also faces restraints such as regulatory challenges and competition from other migraine medications.

Key Players and Market Segments

The market includes prominent players such as GLR Innovations, Biorbyt Ltd, Targetmol, Merck, and others. The report provides a detailed examination of these companies, including their market entry year and various market-related factors[2].

Geographical Analysis

The naratriptan hydrochloride market is expected to grow significantly across various geographical regions. North America and Europe are currently major markets, but the Asia-Pacific region is anticipated to show substantial growth due to increasing healthcare expenditure and a growing patient population[2].

Market Projections

Forecast Period

From 2023 to 2031, the naratriptan hydrochloride market is projected to experience continued and significant expansion. The market size is expected to increase substantially, driven by the growing demand for migraine treatments and the expanding reach of pharmaceutical companies into new markets[2].

Revenue Predictions

The report predicts that the market will reach a substantial value by the end of the forecast period, with revenue growth driven by both established and emerging players in the market. The detailed analysis includes predictions for revenue across different segments and geographical regions[2].

Conclusion

Naratriptan hydrochloride has demonstrated strong efficacy in clinical trials for the acute treatment of migraine headaches. The market for this drug is poised for significant growth, driven by increasing demand and advancements in pharmaceutical technology. As the healthcare sector continues to evolve, naratriptan hydrochloride is expected to remain a key player in the migraine treatment market.

Key Takeaways

• Clinical Efficacy: Naratriptan hydrochloride has shown significant efficacy in treating migraine headaches in clinical trials.
• Market Growth: The market for naratriptan hydrochloride is expected to grow substantially from 2023 to 2031.
• Geographical Expansion: The drug is anticipated to see significant growth across various geographical regions, particularly in the Asia-Pacific area.
• Pharmacokinetics: Naratriptan has a favorable pharmacokinetic profile, with a mean elimination half-life of 6 hours and no drug accumulation upon repeat administration.
• Special Populations: The drug's efficacy and safety have been evaluated in various special populations, including elderly patients and those with renal impairment.

FAQs

What is naratriptan hydrochloride used for?

Naratriptan hydrochloride is used for the acute treatment of migraine headaches.

What were the results of the clinical trials for naratriptan hydrochloride?

The clinical trials showed that naratriptan hydrochloride significantly reduced headache severity in patients, with response rates ranging from 50% to 66% for the 2.5 mg dose compared to placebo[1].

What is the projected market growth for naratriptan hydrochloride?

The market for naratriptan hydrochloride is expected to experience significant growth from 2023 to 2031, driven by increasing demand and pharmaceutical advancements[2].

How does naratriptan hydrochloride affect patients with renal impairment?

In patients with moderate renal impairment, the clearance of naratriptan is reduced by 50%, leading to an increased mean half-life and higher Cmax[4].

What are the key factors driving the market growth for naratriptan hydrochloride?

The market growth is driven by increasing demand for effective migraine treatments, advancements in pharmaceutical technology, and the expanding reach of pharmaceutical companies into new markets[2].

Sources

1. eMPR: Naratriptan Prescription & Dosage Information - MPR - eMPR.com
2. Market Research Intellect: Naratriptan Hydrochloride Market Size, Scope And Forecast Report
3. Tonix Pharmaceuticals: Tonix Pharmaceuticals Reports Third Quarter 2023 Financial
4. FDA: Prescribing Information - AMERGE
5. Drug Central: Naratriptan - Drug Central