AzTrials
AzTrials

Multiple SclerosisPhase 3NCT02869425

To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS

A Phase 3 study testing arbaclofen ER Tablets in people with Multiple Sclerosis and Sperm, run by RVL Pharmaceuticals, Inc. at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This study is designed to assess the effects of a therapeutic dose of arbaclofen extended release (ER) tablets compared with placebo on human sperm concentration, motility, and morphology in male subjects with multiple sclerosis (MS). Read more about this study

Who is it for?
Ages 18 to 55 years, men only
Conditions the study is for
Multiple Sclerosis, Sperm
What is being tested?
arbaclofen ER Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesUnited States
Study dates
Jul 2016to Jan 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • For a subject to be eligible for participation in this study, all of the following criteria must be met at Screening:
  • Sign an informed consent form (ICF) indicating willingness and ability to participate in the study;
  • Be male and between 18 to 55 years old, inclusive, at the time of dosing;
  • Has an established diagnosis of MS for >6 months; subjects with all types of MS (relapsing remitting, secondary-progressive, primary-progressive, or neuromyelitis optica) can be enrolled in the study if they meet all other eligibility criteria;
  • Has spasticity in the extremities that requires daily treatment with anti-spasticity drugs in the judgment of the Investigator;
  • Is able to have an erection and antegrade ejaculation with or without the use of phosphodiesterase 5 inhibitors (sildenafil, tadalfil, etc.);
Show all 21Show fewer
  • The average of each semen parameter (except volume) collected at Screening (Visits 1 and 2) will be calculated to determine if the subject meets the following sperm eligibility criteria:
  • Semen volume > or equal to 1.5 mL,
  • Total sperm per ejaculation > or equal to 15 million,
  • Sperm concentration > or equal to 10 million/mL,
  • Total sperm motility > or equal to 19%, and
  • White blood cell count <3 million/mL,
  • Concomitant use of baclofen is permitted during Screening, but subjects must stop baclofen on the day prior to randomization (Visit 3). All other prohibited concomitant medications (Appendix D) must be discontinued prior to randomization (Visit 3);
  • If receiving disease-modifying medications, these must have been at a stable dose for at least 3 months prior to randomization;
  • All other medications, including AMPYRA® (e.g., dalfampridine, fampridine, 4 aminopyridine), must have been at a stable dose for at least 3 months prior to randomization;
  • Absence of infections, peripheral vascular disease, contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement;
  • Has a creatinine clearance > or equal to 50 mL/min, as calculated by glomerular filtration rate using the Modification of Diet in Renal Disease formula;
  • Be able to swallow tablets whole;
  • Be willing to abstain from ejaculation for at least 3 days prior to the collection of each semen sample;
  • Subject and female partners must agree to use a birth control method while on IP and until 30 days following the last administration of IP; and
  • If acquisition of a semen sample requires participation of the subject's partner, that partner must sign an informed consent and agree to participate in the study.

Who cannot join

  • Subjects will NOT be eligible for inclusion in the study if any of the following criteria apply:
  • Had an acute MS exacerbation requiring treatment within 6 weeks of Screening;
  • Has used intravenous methylprednisolone, or equivalent, within 6 weeks before Visit 1;
  • Use of concomitant medications that would potentially interfere with the actions of the IP or results of the outcome variables (Appendix D) must be stopped prior to randomization. However, concomitant use of baclofen is permitted during Screening, but subjects must stop baclofen on the day prior to randomization (Visit 3). All other prohibited concomitant medications (Appendix D) must be discontinued prior to randomization (Visit 3);
  • Has other known reproductive disorders or an identifiable history of infertility:
  • Vasoligation (surgical ligation of the vas deferens as a means of sterilization);
Show all 35Show fewer
  • Azoospermia or severe oligospermia, asthenospermia, teratospermia, leukocytospermia, or any combination of these at baseline; or
  • Retrograde ejaculation;
  • Has had a sexually transmitted disease within the last year;
  • Has severe spasticity that makes the use of placebo medication inappropriate in the judgment of the Investigator;
  • Has had radiation to the pelvic or groin area;
  • Has a condition that affects spermatogenesis, such as recent severe genitourinary infections and prostatitis;
  • Has had previous prostate surgery or vasectomy;
  • Has been diagnosed by a urologist with any one of the following diseases:
  • Hydrocele of the tunica vaginalis;
  • Hematocele;
  • Torsion of the spermatic cord;
  • Torsion of the testicular appendage;
  • Varicocele II or more severe seminal vesiculitis;
  • Gangrene on the skin of the scrotum;
  • Cryptorchidism, small testis (12 mL, testicular volumes were determined by use of a Prader orchidometer);
  • Congenital absence of the vas deferens;
  • Tuberculosis of the epididymis; or
  • Chronic prostatitis, defined as > or equal to 3 million/mL white blood cell count in semen samples;
  • Has a history of unstable psychiatric disease, or current signs and symptoms of significant medical disorders, such as severe, progressive, or uncontrolled pulmonary, cardiac, gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine, immunologic, or neurological disease;
  • Exhibits suicidality defined as active suicidal plan/intent or active suicidal thoughts in the 6 months before Screening as defined by a suicidal ideation score > or equal to 3 on the C-SSRS, (Appendix B; Has a history of suicide attempts or suicidal ideation within 1 year of Screening as determined by the C-SSRS or medical history or currently is at a serious suicidal risk in the judgment of the Investigator);
  • Has seizure disorder;
  • Has significant cognitive deficit, severe or untreated anxiety, or severe or untreated depression, which in the judgment of the Investigator, may interfere with the ability of the subject to participate in the study;
  • Has a current malignancy or history of malignancy in the last 5 years, except effectively treated basal cell skin carcinoma;
  • Has advanced or uncontrolled diabetes, human immunodeficiency virus infection, history of hepatitis C or active hepatitis B, or any other significant disease, disorder, or significant laboratory finding which, in the judgment of the Investigator, would put the subject at risk because of participation in the study, influence the result of the study, or affect the subject's ability to participate in the study;
  • Has planned elective surgery or other procedures requiring general anesthesia during the study;
  • Current chronic use of long-acting opioids or daily use of short-acting opioids for the treatment of pain;
  • Has participated in another interventional trial within 30 days of Screening;
  • Has a positive laboratory test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C, or controlled substances; or
  • Has a history of alcohol dependence, substance abuse, or binge drinking. The subject should avoid heavy drinking during the weeks of sperm sample collection.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Advance Medical Pain Management & Research Clinic

    Miami, Florida, 33169

  • Meridien Research

    Tampa, Florida, 33604

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Parallel-Group Study to Assess the Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With Multiple Sclerosis

This study is designed to assess the effects of a therapeutic dose of arbaclofen extended release (ER) tablets compared with placebo on human sperm concentration, motility, and morphology in male subjects with multiple sclerosis (MS).

Read the detailed description

Primary Objective:

The primary safety objective is to assess the effects of arbaclofen ER tablets (AERT) compared with placebo on sperm concentration from baseline to the end of 90 days of treatment in male subjects with MS.

Secondary Objectives:

The secondary safety objectives are to assess:

  • The effects of AERT compared with placebo on the following sperm parameters from baseline to the end of 90 days of treatment in male subjects with MS:
  • Semen volume and total sperm count per ejaculate;
  • Sperm motility;
  • Sperm morphology; and
  • Plasma levels of reproductive hormones: Follicle-stimulating hormone (FSH), luteinizing hormone (LH), and total testosterone;
  • The recovery of subjects with 50 % decrease in sperm parameters 90 days after the discontinuation of IP; and
  • The safety and tolerability of IP.
Being tested
arbaclofen ER Tablets, Placebo for arbaclofen ER tablets
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arbaclofen ER TabletsDrug

    Also called AERT

    arbaclofen ER tablets, 10 mg, 15 mg, or 20 mg

  • Placebo for arbaclofen ER tabletsDrug

    Also called Placebo

    matching placebo tablets to arbaclofen ER tablets 10 mg, 15 mg or 20 mg

Study groups in NCT02869425
Study groupRoleWhat they receive
Arbaclofen ER TabletsExperimentalAERT 10 mg twice daily (BID) (20 mg/day) for 7 days, followed by AERT 15 mg BID (30 mg/day) for 7 days
Receives: Drug: arbaclofen ER Tablets
Placebo for Arbaclofen ER TabletsPlacebo comparatorMatching placebo AERT 10 mg twice daily (BID) (20 mg/day) for 7 days, followed by matching placebo AERT 15 mg BID (30 mg/day) for 7 days
Receives: Drug: Placebo for arbaclofen ER tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure of sperm concentration according to WHO guidelines

    The primary safety objective is to assess the effects of arbaclofen ER tablets (AERT) compared with placebo on sperm concentration from baseline to the end of 90 days of treatment in male subjects with MS. Analyses are performed by World Health Organization (WHO) guidelines (WHO, 2010) to obtain volume (mL), pH, sperm concentration motility, and morphology

    Measured: 90 days of treatment

Secondary outcomes (6)

  1. Measure of sperm motility according to the WHO guidelines

    Measured: 90 days of treatment

  2. Measure of Plasma levels of FSH, LH, and total testosterone values and their respective change from baseline values will be summarized by visit

    Plasma levels of FSH, LH, and total testosterone values and their respective change from baseline values will be summarized by visit using an 8-number summary (n, mean, median, SD, 25th percentile, 75th percentile, minimum value, and maximum value).

    Measured: 90 days of treatment

  3. Measure of Semen volume per ejaculate according to the WHO guidelines

    Measured: 90 days of treatment

  4. Measure of total sperm count per ejaculate according to the WHO guidelines

    Measured: 90 days of treatment

  5. Measure of Sperm morphology according to the WHO guidelines

    Measured: 90 days of treatment

  6. The recovery of subjects with 50% decrease in sperm parameters 90 days after the discontinuation of IP

    Measured: 90 days of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionOct 2018 (estimated)
  4. Study completionJan 2019 (estimated)

Why it stopped: suspended due to inability to enroll subjects

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02869425
Sponsor's protocol ID
OS440-PKP06
Status last verified
Aug 2019
First submitted
3 Aug 2016
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing arbaclofen ER Tablets in people with Multiple Sclerosis and Sperm, run by RVL Pharmaceuticals, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure of sperm concentration according to WHO guidelines (time frame: 90 days of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02869425.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in