The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,057
Administered as specified in the treatment arm.
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAE is any AE that start or worsen on or after the date of first dose of study treatment. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.
Time frame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)
Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
Vital sign measurements included heart rate (low: \<=50 beats per minute \[bpm\] and decrease \>=15 bpm; High: \>=120 bpm and increase \>=15 bpm), systolic blood pressure (BP) (low: \<=90 millimeters of mercury \[mmHg\] and decrease \>=20 mmHg; High: \>=180 mmHg and increase \>=20 mmHg) and diastolic BP (low: \<=50 mmHg and decrease \>=15 mmHg; High: \>=105 mmHg and increase \>=15 mmHg).
Time frame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)
Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Potentially clinically significant QTcF values (\>450 to \<=480 millisecond \[msec\], \>480 to \<=500 msec) at any post-baseline visit during treatment period were reported.
Time frame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)
Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit
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Alkermes Investigational Site
Cullman, Alabama, United States
Alkermes Investigational Site
Phoenix, Arizona, United States
Alkermes Investigational Site
Phoenix, Arizona, United States
Alkermes Investigational Site
Phoenix, Arizona, United States
Alkermes Investigational Site
Tucson, Arizona, United States
Alkermes Investigational Site
Berkeley, California, United States
Alkermes Investigational Site
Loma Linda, California, United States
Alkermes Investigational Site
Long Beach, California, United States
Alkermes Investigational Site
San Diego, California, United States
Alkermes Investigational Site
Basalt, Colorado, United States
...and 105 more locations
The C-SSRS is a clinician-administered instrument that systematically assess suicidal ideation and behavior rating scale. It rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent). The scale identifies specific behaviors ranging from "preparatory acts or behavior" to "suicide" which may be indicative of an individual's intent to complete suicide.
Time frame: Up to 98 weeks
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
Laboratory assessments included hematology, biochemistry, and urinalysis. Abnormality criteria: \>=3xupper limit of normal (ULN) in alanine aminotransferase, aspartate aminotransferase; In millimoles per liter (mmol/L) \[bicarbonate\<15/\>31, chloride\<=90, potassium\<3/\>5.5, sodium\<130/\>150\]; In mg per decilitre(mg/dL) {total bilirubin\>=2.0, calcium\<8.2/\>12, total cholesterol\>300, creatinine\>=2.0, glucose\<50/\>200, cholesterol: High density lipoprotein (HDL)\<=30, low density lipoprotein (LDL)\>=160, triglycerides\>=120 \[female(F)\]/\>=160 \[male(M)\], urate\>9/\>8(F), blood urea nitrogen\>30}; \>3xULN in creatine kinase, lactate dehydrogenase; Hematocrit \<=32(F)/\<=37(M) percentage(%),3 point decrease from baseline; Hemoglobin\<=9.5(F)/\<=11.5(M)g/dL; Lymphocytes\<0.5x10\^9/L; In 10\^3/microliter(uL) \[Eosinophils\>1; Absolute neutrophils\<1.5; Platelets\<75.1/\>=700; Leukocytes\<=2.8/\>=16\]; Albumin/creatinine\>200g/kilograms(kg); Beta-2 microglobulin \>0.3milligrams/liter(mg/L); Glucose/protein at least 2+.
Time frame: From first dose to two weeks after last dose of study drug (Up to 98 weeks)