Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED

NCT02713789 | Completed Phase 2 Results

• 1 other identifier: ION04-ED
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction longer than six months that is attributable to an underlying, stable medical condition.

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis

  Physical examination of the penis included inspection and palpation.

  up to Week 24 ± 3 days

• Number of Participants With Significant Changes in Clinical Laboratory Parameters as Measured on Interval Blood and Urine Tests

  Clinical significance was determined by the Investigator using central laboratory values.

  up to Week 24 ± 3 days

• Number of Participants With Significant Changes on the Cardiogram as Measured by Significant Prolongation of QT Intervals and Cardiac Rhythm

  Clinical significance was determined by the Investigator using central laboratory values.

  up to Week 24 ± 3 days

Secondary Outcomes (7)

• Mean Change From Baseline in the Percentage of "Yes" Responses to Questions 2 and 3 of the Sexual Encounter Profile (SEP) at Week 24

  Baseline; Week 24

• Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) at Week 24

  Baseline; Week 24

• Change From Baseline in the Orgasmic Function Domain of the International Index of Erectile Function (IIEF) at Week 24

  Baseline; Week 24

• Change From Baseline in the Sexual Desire Domain of the International Index of Erectile Function (IIEF) at Week 24

  Baseline; Week 24

• Change From Baseline in the Intercourse Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24

  Baseline; Week 24

Study Arms (2)

hMaxi-K

ACTIVE COMPARATOR

Single Treatment/ two escalating dose levels (8000 µg and 16,000 µg injection). In each dose level, 11 participants will receive hMaxi-K and 6 will receive placebo (only one injection per each participant)

Drug: hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)

Placebo (PBS-20% sucrose)

PLACEBO COMPARATOR

PBS-20% sucrose administered during two single treatment dose levels (8000 µg and 16000 µg) by injection (only one injection per each participant)

Drug: Placebo (PBS-20% sucrose)

Interventions

hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection) DRUG

Also known as: hMaxi-K, URO-902

hMaxi-K

Placebo (PBS-20% sucrose) DRUG

Also known as: Placebo

Placebo (PBS-20% sucrose)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Be adult males over 18 years of age diagnosed with erectile dysfunction and whose ED is attributable to an underlying, stable medical condition such as hypertension and atherosclerosis, antihypertensive medication, type I and type II diabetes mellitus, pelvic surgery and pelvic radiation, cerebrovascular accidents (stroke), multiple sclerosis, and Parkinson's disease;
• Participants must have been unable to have successful sexual intercourse for 3 months prior to study entry without specific ED therapy such as Vacuum Erection device (VED), ViagraTM (sildenafil), Cialis TM (tadalafil), MuseTM (alprostadil), or intracavernous injection therapy with an erectile function domain score of IIEF\<21 at screening and baseline;
• Have been unable to tolerate, do not wish to continue, or have had unsuccessful results with, prior therapy for ED, e.g., ViagraTM, intracavernous injection therapy, MuseTM, or VED;
• If diabetic, documentation of HgA1c less than or equal to 8.0% prior to enrollment;
• If receiving medication for hypertension, documentation of blood pressure has been stable on the same medication for at least 2 months prior to enrollment;
• Be heterosexual and in a stable, monogamous relationship of at least six months duration;
• Agree to attempt intercourse with their partner at least four times per month while participating in the study;
• Agree not to use other treatments for ED while participating in this study;
• A prior penile prosthetic implant;
• Have a normal physical examination of the penis;
• If participant had a radical prostatectomy a PSA \<0.4 for at least one year documented by 2 measurements during the preceding year;
• Be literate, able to give written informed consent, and comply with all study procedures and requirements.

You may not qualify if:

• A history of sickle-cell disease, sickle cell trait, or any other medical condition that, in the judgment of the investigator, would contraindicate the administration of study medication or interfere with the study evaluations;
• In the judgment of the investigator any condition that would interfere with participation in the study (including geographical inaccessibility), that would contraindicate the administration of study medication or interfere with the study evaluations.
• Had within six months prior to enrollment any of the following:
• Myocardial infarction
• Cerebrovascular accident
• Uncontrolled hypertension (systolic \>160 or diastolic \>100mmHg)
• Arrhythmia
• Congestive heart failure (dyspnea on minimal exertion or while supine)
• Unstable angina (chest pain greater than three times weekly while on therapy)
• Required treatment with calcium channel, beta-blocker medication, nitrates, or anti-epileptic drugs;
• Poorly controlled diabetes mellitus as defined by HgA1c \> 8.0 mg% at time of enrollment;
• Change in medication for diabetes or hypertension within 2 months of study enrollment;
• Gonadal failure (testosterone \< 200 ng/dl) not treated with hormone replacement;
• History of malignancy except non-melanomatous skin cancers;
• A life expectancy of less than 12 months;

Sponsors & Collaborators

• Urovant Sciences GmbH: lead
• Dasman Diabetes Institute: collaborator
• Ion Channel Innovations: collaborator

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, Dasman, 1180, Kuwait

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Injections

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: JP Nicandro, PharmD
• Organization: Urovant Sciences GmbH

clinicaltrials@urovant.com

833-219-5557

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 21, 2016
• Study Start: April 1, 2015
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

KU (1)