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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02713789
• Date of registration: 01/03/2016
• Prospective Registration: No
• Primary sponsor: Urovant Sciences GmbH
• Public title: Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene for ED
• Scientific title: A Double-blind, Placebo-controlled, Parallel Design, Randomized, Phase 2A Clinical Trial Evaluating the Potential Activity and Safety of hMaxi-K Gene Transfer in Males With Erectile Dysfunction
• Date of first enrolment: April 2015
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02713789
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Kuwait

Key inclusion & exclusion criteria

Inclusion Criteria:

- Eligible participants must meet the following inclusion criteria:

1. Signed Informed Consent

2. 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;

3. 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;

4. 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;

5. If diabetic, documentation of HgA1c less than or equal to 8.0% prior to
enrollment;

6. If receiving medication for hypertension, documentation of blood pressure has
been stable on the same medication for at least 2 months prior to enrollment;

7. Be heterosexual and in a stable, monogamous relationship of at least six months
duration;

8. Agree to attempt intercourse with their partner at least four times per month
while participating in the study;

9. Agree not to use other treatments for ED while participating in this study;

10. Have screening laboratory values and ECG that are within the normal range. See
exclusion criterion below.

11. A prior penile prosthetic implant;

12. Have a normal physical examination of the penis;

13. If participant had a radical prostatectomy a PSA <0.4 for at least one year
documented by 2 measurements during the preceding year;

14. Be literate, able to give written informed consent, and comply with all study
procedures and requirements.

Exclusion Criteria:

1. 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;

2. 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.

3. 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;

4. Poorly controlled diabetes mellitus as defined by HgA1c > 8.0 mg% at time of
enrollment;

5. Change in medication for diabetes or hypertension within 2 months of study enrollment;

6. Gonadal failure (testosterone < 200 ng/dl) not treated with hormone replacement;

7. History of malignancy except non-melanomatous skin cancers;

8. A life expectancy of less than 12 months;

9. An indwelling urethral catheter;

10. A prior penile prosthetic implant;

11. Received an investigational drug, investigational therapy, or other form of ED
therapy, including approved treatments, within the past 30 days;

12. Peyronie's disease;

13. Any screening laboratory values outside of the normal laboratory range as defined by
the central laboratory normal ranges and in the judgment of the investigator is
considered clinically significant (hepatic biochemical markers [AST, ALT, GGT,
alkaline phosphatase, and bilirubin] > twice the upper limit of the normal reference
range may be accepted with written consent of the sponsor).

14. Any clinically significant ECG abnormality

NOTE: Sinus bradycardia of 50-59 bpm is permissible. Other abnormalities that can be normal
variants (and considered clinically insignificant) may be permissible. However,
participants with such abnormalities cannot be randomized without review of their medical
history and prior written approval of the sponsor (or designee).



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Erectile Dysfunction

Intervention(s)

Drug: Placebo (PBS-20% sucrose)

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

Primary Outcome(s)

Number of Participants With Adverse Experiences as Measured by Changes in Physical Examination of the Penis [Time Frame: 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 [Time Frame: up to Week 24 ± 3 days]

Number of Participants With Significant Changes in Clinical Laboratory Parameters as Measured on Interval Blood and Urine Tests [Time Frame: up to Week 24 ± 3 days]

Secondary Outcome(s)

Change From Baseline in the Overall Sexual Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24 [Time Frame: Baseline; Week 24]

Change From Baseline in the Orgasmic Function Domain of the International Index of Erectile Function (IIEF) at Week 24 [Time Frame: Baseline; Week 24]

Change From Baseline in the Intercourse Satisfaction Domain of the International Index of Erectile Function (IIEF) at Week 24 [Time Frame: Baseline; Week 24]

Mean Change From Baseline in the Percentage of "Yes" Responses to Questions 1, 4, and 5 of the Sexual Encounter Profile (SEP) at Week 24 [Time Frame: Baseline; Week 24]

Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) at Week 24 [Time Frame: Baseline; Week 24]

Change From Baseline in the Sexual Desire Domain of the International Index of Erectile Function (IIEF) at Week 24 [Time Frame: Baseline; Week 24]

Mean Change From Baseline in the Percentage of "Yes" Responses to Questions 2 and 3 of the Sexual Encounter Profile (SEP) at Week 24 [Time Frame: Baseline; Week 24]

Secondary ID(s)

ION04-ED

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dasman Diabetes Institute

Ion Channel Innovations

Results

• Results available: Yes
• Date Posted: 08/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02713789