Trial Outcomes & Findings for An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine (NCT NCT01911845)

NCT ID: NCT01911845

Last Updated: 2018-05-30

Results Overview

The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantification \[\< LLOQ\]) 12 weeks after the last dose of study drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug

Results posted on

2018-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
Overall Study STARTED	38
Overall Study Completed Study Drug	37
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	1
Overall Study Other (not specified)	3

Baseline Characteristics

An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=38 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
Age, Continuous	48.2 years STANDARD_DEVIATION 11.0 • n=39 Participants
Sex: Female, Male Female	13 Participants n=39 Participants
Sex: Female, Male Male	25 Participants n=39 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: All enrolled participants who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=38 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	Methadone Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment	97.4 Percentage of participants Interval 92.3 to 100.0	—

SECONDARY outcome

Timeframe: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

Population: All enrolled participants who received at least 1 dose of study drug.

Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation \[≥ LLOQ\] after HCV RNA \< LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA \[2 consecutive HCV RNA measurements \> 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline\] at any time point during treatment) or fail to suppress (HCV RNA ≥ LLOQ) persistently during treatment with at least 6 weeks \[≥ 36 days\] of treatment.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=38 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	Methadone Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
Percentage of Participants With Virologic Failure During Treatment	0 Percentage of participants	—

SECONDARY outcome

Timeframe: From the end of treatment through 12 weeks after the last actual dose of study drug

Population: All randomized participants who received at least 1 dose of study drug with HCV RNA \< LLOQ at the final treatment visit who completed treatment.

Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA \< LLOQ at the end of treatment. Completion of treatment was defined as a study drug duration ≥ 77 days.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=37 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	Methadone Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
Percentage of Participants With Virologic Relapse Post-treatment	0 Percentage of participants	—

SECONDARY outcome

Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Population: Participants who consented for intensive pharmacokinetic blood sampling

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and were analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Area under the plasma concentration-time curve from time 0 to 24 hours (AUC24 in ng\*hr/mL)\] was estimated using noncompartmental analyses. For ABT-450, ritonavir, and ABT-267, the AUC from time 0 to the last measureable concentration (AUCt in ng\*hr/mL) was calculated instead of AUC24 due to time deviations at 24 hours. The AUCt values are approximately equivalent to AUC24. For ABT-333, ABT-333 M1, and RBV, the AUC from time 0 to 12 hours (AUC12 in ng\*hr/mL) after the morning dose was calculated using the 24-hour concentration as the 12-hour concentration as dosing was twice a day and a 12-hour sample was not collected in this study.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=12 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	Methadone n=10 Participants Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-450	27438.94 ng*hr/mL Standard Deviation 34380.77	37174.89 ng*hr/mL Standard Deviation 49655.37
Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ritonavir	14303.27 ng*hr/mL Standard Deviation 8367.86	11375.38 ng*hr/mL Standard Deviation 5586.62
Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-267	1523.48 ng*hr/mL Standard Deviation 4444.58	1486.72 ng*hr/mL Standard Deviation 519.84
Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333	5666.15 ng*hr/mL Standard Deviation 2550.86	5021.41 ng*hr/mL Standard Deviation 2353.06
Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333 M1 metabolite	3086.73 ng*hr/mL Standard Deviation 1807.51	2950.36 ng*hr/mL Standard Deviation 2094.61
Area Under the Plasma Concentration-time Curve (AUC) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ribavirin	33362.24 ng*hr/mL Standard Deviation 10340.16	33499.39 ng*hr/mL Standard Deviation 10697.75

SECONDARY outcome

Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Population: Participants who consented for intensive pharmacokinetic blood sampling

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=12 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	Methadone n=10 Participants Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-450	3269.50 ng/mL Standard Deviation 4388.48	2973.30 ng/mL Standard Deviation 3371.83
Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ritonavir	1261.92 ng/mL Standard Deviation 657.35	888.70 ng/mL Standard Deviation 409.56
Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-267	102.00 ng/mL Standard Deviation 27.21	95.98 ng/mL Standard Deviation 35.56
Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333	805.08 ng/mL Standard Deviation 354.04	671.90 ng/mL Standard Deviation 302.08
Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333 M1 metabolite	469.92 ng/mL Standard Deviation 271.13	439.64 ng/mL Standard Deviation 272.91
Maximum Plasma Concentration (Cmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ribavirin	3389.17 ng/mL Standard Deviation 1064.98	3232.00 ng/mL Standard Deviation 948.39

SECONDARY outcome

Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Population: Participants who consented for intensive pharmacokinetic blood sampling

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. The time to maximum plasma concentration (Tmax; measured in hours) was directly determined from the concentration-time data.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=12 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	Methadone n=10 Participants Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-450	4.38 hours Standard Deviation 1.45	6.81 hours Standard Deviation 6.04
Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ritonavir	4.18 hours Standard Deviation 1.33	7.01 hours Standard Deviation 5.97
Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-267	4.69 hours Standard Deviation 1.00	5.26 hours Standard Deviation 0.98
Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333	4.25 hours Standard Deviation 2.74	4.05 hours Standard Deviation 1.40
Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333 M1 metabolite	4.40 hours Standard Deviation 0.84	4.65 hours Standard Deviation 1.11
Time to Maximum Plasma Concentration (Tmax) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ribavirin	3.72 hours Standard Deviation 2.95	5.83 hours Standard Deviation 4.34

SECONDARY outcome

Timeframe: Pre-dose (time 0) and 2, 4, 6, and 24 hours post-dose

Population: Participants who consented for intensive pharmacokinetic blood sampling

Blood samples were collected pre-dose (time 0) and at 2, 4, 6, and 24 hours post-dose at one visit between treatment week 2 and treatment week 12, and analyzed using validated analytical methods. A total of 22/38 participants consented for intensive pharmacokinetic blood sampling. Minimum plasma concentration (C trough; measured in ng/mL) was directly determined from the concentration-time data.

Outcome measures

Outcome measures
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=12 Participants ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	Methadone n=10 Participants Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-450	170.01 ng/mL Standard Deviation 368.36	458.53 ng/mL Standard Deviation 988.11
Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ritonavir	167.35 ng/mL Standard Deviation 406.50	136.87 ng/mL Standard Deviation 273.44
Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-267	33.75 ng/mL Standard Deviation 17.28	32.78 ng/mL Standard Deviation 14.11
Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333	223.76 ng/mL Standard Deviation 246.63	147.95 ng/mL Standard Deviation 115.20
Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin ABT-333 M1 metabolite	86.98 ng/mL Standard Deviation 110.35	71.10 ng/mL Standard Deviation 83.23
Plasma Trough Concentration (Ctrough) for ABT-450, Ritonavir, ABT-267, ABT-333, ABT-333 M1 Metabolite, and Ribavirin Ribavirin	2555.83 ng/mL Standard Deviation 1115.82	2632.00 ng/mL Standard Deviation 1039.54

Adverse Events

ABT-450/r/ABT-267 and ABT-333, Plus RBV

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=38 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	2.6% 1/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SARCOMA	2.6% 1/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Nervous system disorders CEREBROVASCULAR ACCIDENT	2.6% 1/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).

Other adverse events

Other adverse events
Measure	ABT-450/r/ABT-267 and ABT-333, Plus RBV n=38 participants at risk ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if \<75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
Blood and lymphatic system disorders ANAEMIA	10.5% 4/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Gastrointestinal disorders ABDOMINAL PAIN	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Gastrointestinal disorders DIARRHOEA	7.9% 3/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	7.9% 3/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Gastrointestinal disorders GINGIVAL PAIN	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Gastrointestinal disorders NAUSEA	50.0% 19/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Gastrointestinal disorders VOMITING	10.5% 4/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
General disorders FATIGUE	47.4% 18/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
General disorders IRRITABILITY	10.5% 4/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
General disorders OEDEMA PERIPHERAL	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
General disorders PYREXIA	7.9% 3/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Infections and infestations NASOPHARYNGITIS	7.9% 3/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Infections and infestations ORAL HERPES	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Infections and infestations TOOTH ABSCESS	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Investigations HAEMOGLOBIN DECREASED	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Metabolism and nutrition disorders DECREASED APPETITE	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Musculoskeletal and connective tissue disorders ARTHRALGIA	13.2% 5/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	7.9% 3/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	7.9% 3/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Nervous system disorders DIZZINESS	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Nervous system disorders HEADACHE	31.6% 12/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Nervous system disorders MIGRAINE	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Nervous system disorders PARAESTHESIA	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Psychiatric disorders ANXIETY	13.2% 5/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Psychiatric disorders CONFUSIONAL STATE	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Psychiatric disorders DEPRESSION	7.9% 3/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Psychiatric disorders INSOMNIA	18.4% 7/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Respiratory, thoracic and mediastinal disorders DYSPNOEA	5.3% 2/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).
Skin and subcutaneous tissue disorders RASH	15.8% 6/38 • Adverse events were collected from the time of study drug administration until 30 days after the last dose, up to 16 weeks. Serious adverse events were collected from the time of informed consent until the end of participation in the study (65 weeks).

Additional Information

Global Medical Information

AbbVie

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER