Trial Outcomes & Findings for Retrospective Study of Patients With Spasticity in the Spanish Population (NCT NCT01383681)

Results Overview

The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.

Recruitment status

COMPLETED

Target enrollment

235 participants

Primary outcome timeframe

Baseline

Results posted on

2013-11-14

Participant Flow

This was a retrospective chart review in patients with spasticity in the Spanish population.

Participant milestones

Participant milestones
Measure	All Participants This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
Overall Study STARTED	235
Overall Study COMPLETED	189
Overall Study NOT COMPLETED	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Study of Patients With Spasticity in the Spanish Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=235 Participants This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
Age, Customized 18 to 25 years	21 Participants n=5 Participants
Age, Customized 26 to 35 years	21 Participants n=5 Participants
Age, Customized 36 to 45 years	43 Participants n=5 Participants
Age, Customized 46 to 55 years	48 Participants n=5 Participants
Age, Customized 56 to 65 years	57 Participants n=5 Participants
Age, Customized >65 years	45 Participants n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.

The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Month 12

Population: Planned analysis: All participants. Not enough data was collected for analysis of this outcome measure.

The physician assessed spasticity as per local standard practice. Not enough data was collected for analysis of this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER