Welcome to MediciNova | Clinical Trials

Clinical Trials for Asthma (MN-001)

MediciNova, Inc. recently completed a Phase II study of MN-001 in patients with mild-to-moderate asthma. One hundred and forty-seven (147) patients were randomly assigned to receive placebo or MN-001 tablets in one of three oral dosing regimens (500 mg TID, 750 mg BID, 750 mg QD) for 4 weeks. The primary endpoint of the trial was achieved with a statistically significant improvement in mean FEV1 (forced expiratory volume in 1 second) after 4 weeks of treatment with 500 mg MN-001 TID compared to placebo (p<0.021; intent-to-treat, observed cases). A similar trend was observed for the 750 mg BID dose (p<0.058). Positive trends in secondary outcome measures were also observed in the 500 mg TID treatment group, including serial spirometry, morning and evening peak flow rates and PC20 values in a methacholine challenge test (common measures of respiratory function). MN-001 was well tolerated in this trial with 89% of patients completing 4 weeks of treatment. There was no apparent difference between placebo and any of the active treatment groups in adverse events leading to discontinuation or in adverse events attributable to treatment. No serious adverse events were reported in this trial.

 

On November 16, 2006 MediciNova reported intiation of a Phase III program in MN-001 for the treatment of asthma.

The first Phase III trial in this program will involve approximately 705 asthma patients enrolled at 75 - 90 clinical sites in the U.S. Mild-to-moderate asthma patients will receive placebo or MN-001 (750 mg BID, 500 mg TID) for 12 weeks in this randomized, placebo-controlled, double-blind study. The primary endpoint of the trial will be the change from baseline in mean FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment.

Secondary outcome measures will include a self-administered Asthma Quality of Life Questionnaire, the change from baseline in morning and evening peak flow rates, rescue beta-agonist use, serial spirometry parameters including assessment of acute effects following first dose on Day 1, daytime asthma symptom scores, nighttime awakenings from asthma, physician's global assessment, number of asthma exacerbations, discontinuations due to asthma, Clinical Global Impression evaluations and change in urinary LTE4 levels.

To learn more about this clinical trial or to find out if the clinical trial is enrolling patients in your area, please visit www.clinicaltrials.gov .

Additional Phase III trials are planned. Development of a continuous release formulation of MN-001 will parallel the initial Phase III trials.

 

Asthma Patient Advocacy and Education Resources

The Asthma and Allergy Foundation of America (AAFA) is the premier patient organization dedicated to improving the quality of life for people with asthma and allergies and their caregivers, through education, advocacy and research. AAFA, a not-for-profit organization founded in 1953, provides practical information, community based services, support and referrals through a national network of chapters and educational support groups. AAFA also sponsors research toward better treatments and a cure for asthma and allergic diseases.

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Clinical Trials for Status Asthmaticus (MN-221)

MN-221 is highly-selective b2-adrenergic receptor agonist under development by MediciNova for the treatment of status asthmaticus. Preclinical testing in vitro and in vivo shows MN-221 to be more selective for the b2-adrenergic receptor than other b2-adrenergic receptor agonists used to treat status asthmaticus. This improved selectivity may result in fewer cardiovascular side effects than are commonly observed with these other agents.

Importantly, MediciNova has developed an intravenous formulation of MN-221 that may effectively bypass the constricted airways in status asthmaticus to deliver effective concentrations of the drug to the lungs.

The first Phase II trial in the status asthmaticus program will involve 28 mild-to-moderate asthma patients who will receive a 15-minute intravenous infusion of MN-221 or placebo in this randomized, placebo-controlled, dose-escalating crossover-design study. The primary endpoint of the trial will be the change from baseline in mean FEV1 (forced expiratory volume in 1 second) after a 15-minute infusion of MN-221.

To learn more about this clinical trial or to find out if the clinical trial is enrolling patients in your area, please visit www.clinicaltrials.gov .

Clinical Trials for Insomnia (MN-305)

MediciNova, Inc. has initiated enrollment in a Phase II exploratory study with MN-305 in the United States, for the treatment of patients with primary insomnia with sleep maintenance difficulties.

The Phase II, randomized, double-blind, placebo-controlled study is being conducted in 10 sites throughout the U.S.  A minimum of 75 subjects are expected for enrollment.  The study will assess the effects of three dosages of MN-305 (1 mg, 3 mg and 6 mg) and placebo in patients with primary insomnia characterized by sleep maintenance difficulties.

To learn more about this clinical trial or to find out if the clinical trial is enrolling patients in your area, please visit www.clinicaltrials.gov

Clinical Trials for Interstitial Cystitis (MN-001)

On January 16, 2007 MediciNova, Inc. reported results in a Phase II/III clinical study with MN-001 for the treatment of interstitial cystitis. This Phase II/III trial was a randomized, double-blind, placebo controlled study in 305 patients with interstitial cystitis.

While MN-001 was well-tolerated, MN-001 did not show a statistically significant clinical benefit compared to placebo on the primary endpoint (to be much or very much improved overall on a patient-rated Global Response Assessment) at the doses tested in this trial (500mg once or twice a day for 8 weeks).

Results from this Phase II/III trial indicated that IC patients were more than twice as likely to respond on 500 mg of MN-001 administered twice a day compared to placebo (25% compared to 12%, p=0.04) after 4 weeks of treatment. This difference, however, was not observed at 8 weeks due to continued improvement among placebo-treated patients. The response rate of patients treated with 500 mg of MN-001 once a day did not significantly differ from placebo at either 4 or 8 weeks.

To learn more about this clinical trial or to find out if the clinical trial is enrolling patients in your area, please visit www.clinicaltrials.gov .

Interstitial Cystitis Resources

Interstitial Cystitis Network
www.ic-network.com/

National Kidney and Urological Diseases Information Clearinghouse (NKUDIC)
kidney.niddk.nih.gov/kudiseases/pubs/interstitialcystitis/

Urology Channel
www.urologychannel.com/interstitialcystitis/index.shtml

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Clinical Trials For Cancer (MN-029)

MediciNova, Inc. is currently enrolling patients in two Phase I trials. The first Phase I trial with MN-029 is an open-label, dose-escalation study in patients with advanced solid or metastatic tumors. MN-029 is being dosed by a 10-20 minute intravenous infusion every 21 days for three cycles, and doses will increase under an accelerated titration design. This clinical study will generate preliminary data on the safety, toxicity, and maximum tolerated dose of single doses of MN-029 when administered intravenously. It will also provide preliminary data on the effect of MN-029 on tumor blood flow and size.

The second Phase I clinical trial utilizes a weekly intravenous dosing regimen of MN-029 for three weeks followed by a two-week recovery period. This clinical trial is an open-label, dose-escalation, safety and tolerability study in patients with advanced solid or metastatic tumors. MN-029 will be administered as a 10-20 minute intravenous infusion, and doses will increase under an accelerated titration design. This clinical study will generate preliminary data on the safety, toxicity, and maximum tolerated dose of multiple doses of MN-029 when administered intravenously. It will also provide preliminary data on the effect of MN-029 on tumor blood flow and size.

To learn more about this clinical trial or to find out if the clinical trial is enrolling patients in your area, please visit www.clinicaltrials.gov .

Cancer Resources

American Cancer Society
http://www.cancer.org/docroot/home/index.asp

AICR is the cancer charity that fosters research on diet and cancer prevention and educates the public about the results
http://www.aicr.org/index.lasso

NCI Resources

http://www.oncolink.com/resources/resources.cfm?c=2

http://www.nci.nih.gov/

Includes PDQ, a series of statements from the National Cancer Institute which contain treatment summaries, for both patients and professionals.

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Clinical Trials for Multiple Sclerosis (MN-166)

MediciNova, Inc. completed enrollment of 297 patients in a Phase II clinical study with MN-166 for the treatment of multiple sclerosis (MS). This Phase II study is being conducted in Eastern Europe and will compare two oral doses of MN-166 to placebo in patients with relapsing-remitting MS. The study will measure reduction in MS lesions in the brain as detected by MRI (magnetic resonance imaging), reductions in annualized relapse rates and functional status as determined by the EDSS (Expanded Disability Status Scale).

MS Education Resources

The Multiple Sclerosis Association of America

Their mission is to ease the day-to-day challenges of individuals with multiple sclerosis and their caregivers.

The National Multiple Sclerosis Society

The Society and its network of chapters nationwide promote research, educate, advocate on critical issues, and organize a wide range of programs including support for the newly diagnosed and those living with MS over time.

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Clinical Trials for Preterm Labor (MN-221)

MediciNova recently completed enrollment in a Phase I clinical study with MN-221 in the United States, for the management of preterm labor. Phase II planning is currently ongoing.

Preterm Labor Resources

March of Dimes
www.marchofdimes.com/pnhec/188_1080.asp

American Pregnancy Association
www.americanpregnancy.org/labornbirth/prematurelabor.html

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Clinical Trials for Urinary Incontinence (MN-246)

MediciNova, Inc. is currently enrolling healthy volunteers into a Phase I, double-blind, randomized, placebo-controlled, single escalating dose clinical trial to determine the safety, tolerability and pharmacokinetics of MN-246.

The Phase I study will evaluate single doses of MN-246 administered orally to young, healthy male and female subjects to provide preliminary information on the safety, tolerability, pharmacokinetics and maximum tolerated single dose of MN-246.

Urinary Incontinence Resources

Urology Channel
www.urologychannel.com/bladdercontrol/index.shtml

American Urological Association
www.urologyhealth.org/

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Clinical Trials for Generalized Anxiety Disorder (MN-305)

On June 11, 2006 MediciNova, Inc. reported results in a Phase II/III clinical study with MN-305 in the United States, for the treatment of patients with Generalized Anxiety Disorder (GAD).

The Phase II, randomized, double-blind, placebo-controlled study was being conducted in 416 GAD patients. The study evaluated 10 weeks of treatment in patients randomized to two flexible dosing regimens of 0.5 to 6 mg/day, 1 to 12 mg/day or placebo. The primary efficacy outcome measure will be change from baseline in the Hamilton Anxiety Rating Scale (HAMA) total score.

Trends for improvement in all efficacy outcome measures were observed in patients treated with MN-305. Statistically significant improvements in item 1 of the HAM-A (anxious mood) were observed through eight weeks of treatment with MN-305, however, statistical significance on the primary outcome measure of the trial (change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score) was not achieved. MN-305 was well tolerated at all doses in the trial.

To learn more about this clinical trial, please visit www.clinicaltrials.gov.

Generalized Anxiety Disorder Resources

National Mental Health Association
www.nmha.org/infoctr/factsheets/31.cfm

Anxiety Disorders Association of America
www.adaa.org/AnxietyDisorderInfor/GAD.cfm

Mental Health Channel
www.mentalhealthchannel.net/gad/

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