Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets. (NCT NCT02271217)
NCT ID: NCT02271217
Last Updated: 2018-06-07
Results Overview
"The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered "Responders".
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
377 participants
Primary outcome timeframe
Week 12
Results posted on
2018-06-07
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Placebo
|
Dalfampridine-ER 7.5 mg
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 7.5mg
|
Dalfampridine-ER 10mg
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 10mg
|
|---|---|---|---|
|
Overall Study
STARTED
|
126
|
126
|
125
|
|
Overall Study
COMPLETED
|
115
|
113
|
113
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Two Dose Strengths of Dalfampridine Extended Release Tablets.
Baseline characteristics by cohort
| Measure |
Placebo
n=126 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Placebo
|
Dalfampridine-ER 7.5 mg
n=126 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 7.5mg
|
Dalfampridine-ER 10mg
n=125 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 10mg
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 11.68 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 10.48 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 10.01 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 10.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
241 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
100 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
299 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Weight at Screening
|
83.98 kg
STANDARD_DEVIATION 14.914 • n=5 Participants
|
82.43 kg
STANDARD_DEVIATION 14.514 • n=7 Participants
|
84.49 kg
STANDARD_DEVIATION 14.771 • n=5 Participants
|
83.63 kg
STANDARD_DEVIATION 14.72 • n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Includes all randomized subjects who took at least one dose of double-blind study treatment, had at least one 2MinWT assessment during the placebo run-in period, and at least one 2MinWT assessment during the double-blind treatment period.
"The 2MinWT measures the distance a subject can walk in 2 minutes. Participants showing at Least a 20% Improvement on the 2MinWT at 12-weeks are considered "Responders".
Outcome measures
| Measure |
Placebo
n=126 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Placebo
|
Dalfampridine-ER 7.5 mg
n=121 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 7.5mg
|
Dalfampridine-ER 10mg
n=121 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 10mg
|
|---|---|---|---|
|
Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12
Responder
|
17 participants
|
17 participants
|
23 participants
|
|
Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12
Non-Responder
|
97 participants
|
96 participants
|
90 participants
|
|
Proportion of Subjects Who Show at Least a 20% Improvement on the Two Minute Walk Test (2MinWT) at Week 12
Missing
|
12 participants
|
8 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline, week 12Population: Includes all randomized subjects who took at least one dose of double-blind study treatment, had at least one 2MinWT assessment during the placebo run-in period, and at least one 2MinWT assessment during the double-blind treatment period.
The Walk-12 is a 12-question questionnaire that asks subjects to rate limitations of their mobility during the preceding two weeks on a 5-point scale (from 1= not at all to 5=extremely). For each visit, the Walk-12 score will be calculated by summing the 12 components and transforming into a scale with a range of 0 to 100. A higher score indicates a greater degree of limitation in walking. A negative change indicates an improvement in walking. 0 = no limitation in mobility to 100 extreme limitation in mobility. Walk-12 Score = 100 \* \[(Mean of the 12 items) - 1\]/(5-1)
Outcome measures
| Measure |
Placebo
n=126 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Placebo
|
Dalfampridine-ER 7.5 mg
n=121 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 7.5mg
|
Dalfampridine-ER 10mg
n=121 Participants
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 10mg
|
|---|---|---|---|
|
Change From Baseline on the Walking Impact Scale (Walk-12) at Week 12 (Key Secondary)
|
45.40 units on a scale
Standard Deviation 22.96
|
48.34 units on a scale
Standard Deviation 25.43
|
49.26 units on a scale
Standard Deviation 25.98
|
Adverse Events
Placebo
Serious events: 8 serious events
Other events: 75 other events
Deaths: 0 deaths
Dalfampridine-ER 7.5 mg
Serious events: 6 serious events
Other events: 85 other events
Deaths: 0 deaths
Dalfampridine-ER 10mg
Serious events: 3 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=126 participants at risk
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Placebo
|
Dalfampridine-ER 7.5 mg
n=126 participants at risk
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 7.5mg
|
Dalfampridine-ER 10mg
n=122 participants at risk
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 10mg
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.82%
1/122 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Myocardial Infarction
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
General disorders
Gait Disturbance
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.82%
1/122 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.82%
1/122 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Convulstion
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Complex Partial Seizures
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
Other adverse events
| Measure |
Placebo
n=126 participants at risk
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
Placebo
|
Dalfampridine-ER 7.5 mg
n=126 participants at risk
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 7.5mg
|
Dalfampridine-ER 10mg
n=122 participants at risk
Subjects randomized 1:1:1 to receive either dalfampridine-ER 7.5mg, dalfampridine-ER 10mg, or matching placebo tablets taken twice daily 12 hours apart.
dalfampridine-ER 10mg
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.5%
3/122 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.5%
3/122 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
General disorders
Fatigue
|
6.3%
8/126 • Number of events 8
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.2%
4/126 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.5%
3/122 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
General disorders
Gait Disturbance
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
4.8%
6/126 • Number of events 6
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.2%
4/126 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/122
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
General disorders
Edema Peripheral
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
6.3%
8/126 • Number of events 8
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
9.0%
11/122 • Number of events 11
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
5/126 • Number of events 5
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.2%
4/126 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
4.1%
5/122 • Number of events 5
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.2%
4/126 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.82%
1/122 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Bronchitis
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.82%
1/122 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Influenza
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
7/126 • Number of events 7
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
9.5%
12/126 • Number of events 12
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
10.7%
13/122 • Number of events 13
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.3%
4/122 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.3%
4/122 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.5%
3/122 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.82%
1/122 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
4/126 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
4.1%
5/122 • Number of events 5
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.0%
5/126 • Number of events 5
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
4.1%
5/122 • Number of events 5
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.8%
6/126 • Number of events 6
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.3%
4/122 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.5%
3/122 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.82%
1/122 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Dizziness
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
7.9%
10/126 • Number of events 10
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.3%
4/122 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Headache
|
4.8%
6/126 • Number of events 6
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
4.8%
6/126 • Number of events 6
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Balance Disorder
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.5%
3/122 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Psychiatric disorders
Depression
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Psychiatric disorders
Insomnia
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.79%
1/126 • Number of events 1
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
4.1%
5/122 • Number of events 5
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/126
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
2.4%
3/126 • Number of events 3
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/122 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Hypertension
|
4.0%
5/126 • Number of events 5
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
1.6%
2/126 • Number of events 2
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
3.3%
4/122 • Number of events 4
Clinicaltrials.gov definition of Adverse Events is any " Adverse events that are not Serious Adverse Events." The adverse events summary results provided for this study include both Serious Adverse Events and other Adverse Events that are not Serious Adverse Events. Adverse Events are reporting on the Safety Population which includes all subjects who received at least one dose of double-blind study treatment.
|
Additional Information
Holly Roberts, Executive Medical Director
Acorda Therapeutics
Phone: 914-326-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding the study results for a period up to 30 days from the date the communication is submitted to the sponsor. The sponsor shall have the right to defer proposed publication an additional 60 days from the end of the review period. The sponsor cannot require changes to the communication and cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER