Trial Outcomes & Findings for Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment (NCT NCT01316055)

NCT ID: NCT01316055

Last Updated: 2012-11-07

Results Overview

AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 42 participants
• Primary outcome timeframe: 0 and 1,2,3,4,5,6,8, and 12 hours after the last dose
• Results posted on: 2012-11-07

Participant Flow

First subject screened January, 2011. Last subject out August, 2011. Full Service Phase 1 Units.

Participant milestones

Measure	Healthy: Dalfampridine-ER 7.5 mg Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Mild Renal: Dalfampridine-ER 7.5 mg Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Moderate Renal: Dalfampridine-ER 7.5 mg Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
Overall Study STARTED	13	17	12
Overall Study COMPLETED	12	17	12
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	Healthy: Dalfampridine-ER 7.5 mg Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Mild Renal: Dalfampridine-ER 7.5 mg Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Moderate Renal: Dalfampridine-ER 7.5 mg Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Pharmacokinetics (PK) of Dalfampridine-ER 7.5 mg BID in Healthy Volunteers and Subjects With Mild or Moderate Renal Impairment

Baseline characteristics by cohort

Measure	Healthy: Dalfampridine-ER 7.5 mg n=13 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Mild Renal: Dalfampridine-ER 7.5 mg n=17 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Moderate Renal: Dalfampridine-ER 7.5 mg n=12 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	23 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	19 Participants n=4 Participants
Age Continuous	41.9 years STANDARD_DEVIATION 14.65 • n=5 Participants	63.2 years STANDARD_DEVIATION 7.22 • n=7 Participants	67.1 years STANDARD_DEVIATION 7.65 • n=5 Participants	57.7 years STANDARD_DEVIATION 14.71 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	28 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	5 participants n=4 Participants
Race/Ethnicity, Customized White	11 participants n=5 Participants	11 participants n=7 Participants	8 participants n=5 Participants	30 participants n=4 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants

PRIMARY outcome

Timeframe: 0 and 1,2,3,4,5,6,8, and 12 hours after the last dose

Population: Intention to treat (ITT)

AUC(0-12) was based on blood samples taken at specified outcome measure time frame for dalfampridine-ER 7.5 mg tablets in healthy adult volunteers and people with mild or moderate renal impairment.

Outcome measures

Measure	Healthy: Dalfampridine-ER 7.5 mg n=12 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Mild Renal: Dalfampridine-ER 7.5 mg n=17 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Moderate Renal: Dalfampridine-ER 7.5 mg n=12 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
The Steady State Area Under the Drug Concentration Time Curve From 0 to 12 Hours Post Dose AUC(0-12).	157.8 hour*nanogram/milliliter Interval 130.4 to 190.9	276.5 hour*nanogram/milliliter Interval 241.5 to 316.7	415.3 hour*nanogram/milliliter Interval 383.8 to 449.4

SECONDARY outcome

Timeframe: 7 days

Population: ITT

Outcome measures

Measure	Healthy: Dalfampridine-ER 7.5 mg n=12 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Mild Renal: Dalfampridine-ER 7.5 mg n=17 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Moderate Renal: Dalfampridine-ER 7.5 mg n=12 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
The Maximum Measured Plasma Concentration (Cmax) at Steady State, of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.	20.61 nanogram/milliliter Interval 17.76 to 23.92	33.92 nanogram/milliliter Interval 29.92 to 38.47	46.69 nanogram/milliliter Interval 43.68 to 49.91

SECONDARY outcome

Timeframe: 7 days

Population: ITT

Outcome measures

Measure	Healthy: Dalfampridine-ER 7.5 mg n=12 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Mild Renal: Dalfampridine-ER 7.5 mg n=17 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Moderate Renal: Dalfampridine-ER 7.5 mg n=12 Participants Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
The Steady State Fractional Clearance, Calculated as the Dose / AUC(0-12) (CL/Fss) of Dalfampridine-ER 7.5 mg Tablets in Healthy Adult Volunteers and Those With Mild and Moderate Renal Impairment and Examine Between-group Differences.	47.54 liter/hour Interval 39.29 to 57.52	27.12 liter/hour Interval 23.68 to 31.06	18.06 liter/hour Interval 16.69 to 19.54

Adverse Events

Healthy: Dalfampridine-ER 7.5 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Mild Renal: Dalfampridine-ER 7.5 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Moderate Renal: Dalfampridine-ER 7.5 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy: Dalfampridine-ER 7.5 mg n=13 participants at risk Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Mild Renal: Dalfampridine-ER 7.5 mg n=17 participants at risk Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up	Moderate Renal: Dalfampridine-ER 7.5 mg n=12 participants at risk Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
Gastrointestinal disorders Abdominal distension	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	5.9% 1/17 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
General disorders Any TEAEs (treatment emergent adverse effects)	61.5% 8/13 • Number of events 10 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	47.1% 8/17 • Number of events 10 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	33.3% 4/12 • Number of events 7 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	16.7% 2/12 • Number of events 2 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Investigations Blood creatine phosphokinase increased	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	5.9% 1/17 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Gastrointestinal disorders Diarrhoea	7.7% 1/13 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	8.3% 1/12 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Nervous system disorders Dizziness	15.4% 2/13 • Number of events 2 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	5.9% 1/17 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	8.3% 1/12 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.7% 1/13 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	5.9% 1/17 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Nervous system disorders Headache	15.4% 2/13 • Number of events 2 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	17.6% 3/17 • Number of events 3 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 1/13 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	8.3% 1/12 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Vascular disorders Hypertension	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	5.9% 1/17 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	8.3% 1/12 • Number of events 2 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Blood and lymphatic system disorders Lymphadenitis	7.7% 1/13 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Musculoskeletal and connective tissue disorders Muscular weakness	7.7% 1/13 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/17 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	5.9% 1/17 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/13 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	5.9% 1/17 • Number of events 1 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.	0.00% 0/12 • Total study participation was to last for approximately 7 days consisting of 2 in-clinic confinement periods (exclusive of up to 14 days of screening), and follow-up 3 days post final discharge. All adverse events with an onset time after dosing and up to 72 hours after the last dose of study drug were considered treatment-emergent. In addition, adverse events with onset date before start of trial treatment but with worsening in intensity during the treatment period were also considered treatment-emergent.

Additional Information

Herbert Henney, PharmD

Vice President - Clinical Development & Medical Affairs (CDMA)

Phone: (914) 347-4300

Email: hhenney@acorda.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
• Publication restrictions are in place

Restriction type: OTHER