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Trial · NCT01606137

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of Adverse Events as a Measure of Subject Safety.Up to 1051 days
Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.
SecondaryChange From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.0 - 52 weeks
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
SecondaryChange From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.0 - 52 weeks.
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
SecondaryChange From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.0 - 52 weeks.
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
SecondaryChange From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.0 - 52 weeks.
Subjects were asked to rate the severity of their primary symptom each week in the diary using an 11-point Numerical Rating Scale, where zero = "best possible" and 10 = "worst possible". A negative value indicates an improvement in score from baseline.
SecondarySubject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.Up to 1051 daysAssessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
SecondaryInvestigator Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.Up to 1051 days
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
SecondarySubject Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.Up to 1051 daysAssessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
SecondaryInvestigator Assessment of Benefit at the Last Study Visit in Those Experiencing Central Neuropathic Pain.Up to 1051days
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
SecondarySubject Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.Up to 1051Assessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
SecondaryInvestigator Assessment of Benefit at the Last Study Visit in Those Experiencing Pain.Up to 1051 days
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
SecondarySubject Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.Up to 1051 daysAssessment of benefit achieved at study completion/withdrawal was evaluated by the subject, and the number of subjects who perceived a benefit from treatment is presented.
SecondaryInvestigator Assessment of Benefit at the Last Study Visit in All Multiple Sclerosis Subjects.Up to 1051 days.
Assessment of benefit achieved at study completion/withdrawal was evaluated by the investigator, and the number of subjects that investigators considered to have experienced a benefit from the treatment is presented.
SecondaryInvestigator Global Assessment at the Last Study Visit in Subjects With Neuropathic Pain Due to Multiple Sclerosis.Up to 1051 days
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.
SecondaryInvestigator Global Assessment at the Last Study Visit in Subjects With Central Neuropathic Pain.Up to 1051 days.
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.
SecondaryInvestigator Global Assessment at the Last Study Visit in Subjects With Pain.Up to 1051 days.
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.
SecondaryInvestigator Global Assessment at the Last Study Visit in Subjects With Multiple Sclerosis.Up to 1051 days.
Investigators rated the global severity of the subject's underlying primary condition, e.g. their MS or spinal cord injury, since the previous visit using a five point scale of "much worse", "worse", "no change", "better", "much better". The number of subjects rated by the investigator as "better" or "much better" at the last study visit is presented.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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