To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subj… (NCT02869425) | Clinical Trial Compass
WithdrawnPhase 3
To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS
Stopped: suspended due to inability to enroll subjects
United States0Started 2016-07
Plain-language 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).
Who can participate
Age range18 Years – 55 Years
SexMALE
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Inclusion criteria
✓. 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.);
✓. 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,
Exclusion criteria
✕. 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);
What they're measuring
1
Measure of sperm concentration according to WHO guidelines